- 1 What happens if I stay awake after taking a sleeping pill?
- 2 Does zopiclone force you to sleep?
- 2.1 How many hours will I sleep with zopiclone?
- 2.2 A Weird Side Effect Of Zopiclone (Imovane) | Pharmacist Explains
- 2.3 What happens if you don’t sleep after taking zolpidem?
- 3 Why does zopiclone feel so good?
- 4 Will I wake up on zopiclone?
- 5 Does zopiclone make it hard to wake up?
- 6 Why doesn’t zopiclone make me sleepy?
- 7 What can you not mix with zopiclone?
- 8 What is the minimum sleep for zolpidem?
- 9 What are the top three sleeping pills?
- 10 How long should you wait to lay down after taking a pill?
- 11 How easy is it to wake up after taking sleeping pills?
What happens if I stay awake after taking a sleeping pill?
Effects Of Sonata – Like Lunesta and Ambien, Sonata should not be taken during waking hours. If it is, it can cause severe reactions that could lead to bodily harm and death. What makes Sonata different is that the user only needs to dedicate four hours to sleep; whereas Lunesta and Ambien require a minimum of 8 hours.
With any of these pills, it is important take them immediately before bed. Staying awake after taking a sleeping pill can cause dangerous side effects to surface, including hallucinations and lapses in memory. However, as with any medication, common side effects can be expected with regular use of Sonata.
Dizziness Headaches Muscle pain Nausea
If any other side effects surface, or those listed are especially severe, then the user should seek help from the prescribing doctor immediately. Taking Sonata within an hour of a heavy meal can also postpone the effects and cause lapses in memory.
Does zopiclone force you to sleep?
About zopiclone Zopiclone is a type of sleeping pill that can be taken for short-term treatment of severe insomnia. It helps you fall asleep more quickly, and also helps stop you waking up during the night. It works by affecting a calming chemical in your brain called gamma-aminobutyric acid (GABA).
Zopiclone takes around 1 hour to work.It’s usually prescribed for just 2 to 4 weeks. This is because your body gets used to it quickly and after this time it’s unlikely to have the same effect. Your body can also become dependent on it.Common side effects are a metallic taste in your mouth, a dry mouth, and daytime sleepiness.Do not drink alcohol while you’re on zopiclone. Having them together can make you go into a deep sleep where you find it difficult to wake up.If zopiclone makes you feel sleepy in the daytime, do not drive a car, ride a bike or use machinery.
Page last reviewed: 18 February 2022 Next review due: 18 February 2025 : About zopiclone
How many hours will I sleep with zopiclone?
– Zopiclone can affect your recent memory, especially if you do not go to bed just after taking it, or if your sleep gets interrupted. Make sure that you can get seven to eight hours of uninterrupted sleep if you are going to take zopiclone. Some people have reported doing things like walking, preparing food, making phone calls, having sex and even driving while they were not fully awake.
Can zopiclone have the opposite effect?
Case Report: Paradoxical insomnia in a patient taking zopiclone 1 Department of Psychiatry, University of Alberta Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada 2 Department of Young Adult, Alberta Hospital Edmonton, Edmonton, Alberta, Canada Find articles by 3 Queen Elizabeth II Hospital, Grande Prairie, Alberta, Canada Find articles by 2017 BMJ Publishing Group Ltd We present a case of a man aged 20 years who was diagnosed with a major depressive disorder and was started on escitalopram and zopiclone.
- The patient had a significant response to escitalopram except that he developed severe insomnia which dramatically resolved following discontinuation of zopiclone.
- The patient was recommenced on low dose of zopiclone and unfortunately redeveloped moderate insomnia.
- The patient was thoroughly investigated and zopiclone was determined to have paradoxically caused the insomnia.
Zopiclone is a commonly prescribed non-benzodiazepine hypnotic drug and it is used as a short-term treatment strategy to improve sleep in a number of psychiatric disorders. It is extremely rare for zopiclone to cause insomnia as a side effect. We present a patient who developed severe insomnia as a result of the short-term use of zopiclone.
The patient was a man aged 20 years who was diagnosed with a major d epressive disorder (MDD) (DSM-V) and was started on escitalopram with beneficial effect for the predominant affective symptoms except for sleep disturbance. The patient was then started on zopiclone and consequently developed a severe insomnia which only resolved after withdrawal of zopiclone and attempt to reintroduce zopiclone at a lower dose resulted in re-emergence of insomnia.
Rebound insomnia had been previously reported following sudden withdrawal of zopiclone. However, we have not come across any case report of intractable insomnia as a direct consequence of the use of zopiclone. It is therefore important to be aware of such an extremely rare side effect when treating patients with worsening insomnia, despite adequate dosage of zopiclone.
We present a man aged 20 years who presented to our psychiatric outpatient clinic with a 3-month history of symptoms of depression characterised by low mood, anhedonia, decreased motivation, lack of energy, recurrent suicidal ideas and decreased total sleep time from his baseline of 9 hours per night to 6 hours.
There were no associated features of psychosis or bipolar disorder. No history of substance abuse, including alcohol, coffee and tobacco. No chronic or acute physical illness, no history of head injury and his physical examination were negative to any stigmata of neurovascular disorder.
- He had a stable and supportive psychosocial environment.
- He has a positive family history of MDD.
- A diagnosis of MDD was made using DSM-V criteria.
- The patient was started on escitalopram which was optimised to a daily dose of 20 mg every morning.
- The patient’s symptoms significantly reduced except for increased sleep latency, despite a self-report of healthy sleep hygiene.
There was no reason to doubt his medication adherence. He was prescribed zopiclone 7.5 mg at bedtime and within 2 days, he was reporting worsening sleep quality but had no other features of mood disorder. Zopiclone was optimised to 15 mg at bedtime, but unfortunately, he developed intractable insomnia characterised by increased sleep latency, decreased total sleep time from baseline of 9 to 3–4 hours and overall dissatisfaction with quality of sleep.
- The patient was referred for sleep study, which ruled out primary insomnia.
- The following investigations were performed.
- Drug urine screening was negative to illicit substances, including benzodiazepines.
- CBC (diff), electrolytes, thyroid function test and liver enzymes were normal.
- EEG shows a mild intermittent bihemispheric disturbance of cerebral activity; no frank epileptiform abnormalities were seen.
CT scan of the brain was normal. We initially thought that this may be an atypical presentation of a bipolar affective disorder. However, there was no persistent elevation of mood or lability of mood. There was no evidence of inflated self-esteem or overtalkativeness and no flight of ideas or racing thoughts.
There was no family history of bipolar disorder. Anxiety disorder was a second differential diagnosis. However, there were no evidence of phobias or free floating anxiety and no history of panic attack. There was no evidence to support post-traumatic stress disorder. The patient had no associated medical comorbidities such as coronary heart disease, obstructive airway disease or endocrine abnormalities.
A Weird Side Effect Of Zopiclone (Imovane) | Pharmacist Explains
We also considered the possibility of primary insomnia but were ruled out following assessment by a sleep specialist. The sleep specialist advised active treatment of the depressive disorder. Hence, optimisation of escitalopram to maximum dosage and further change of antidepressants to duloxetine and mirtazapine and a combination of the latter with escitalopram and cognitive–behavioural therapy focusing on anxiety management and psychoeducation on sleep hygiene were started.
- Unfortunately, the patient continued to have insomnia for over 6 weeks despite active treatment protocol as mentioned above.
- We decided to decrease zopiclone to 7.5 mg from 15 mg bedtime.
- Consequently, the patient reported a moderate improvement of sleep within 24 hours of dose reduction in zopiclone.
It was then decided to discontinue zopiclone which resulted in dramatic improvement of sleep back to baseline of 9 hours per night. The patient consented to a reintroduction of zopiclone at a much lower dose of 3.75 mg at bedtime and almost within the same day, there was a modest disruption in sleep quality with return to normal sleep after stopping the zopiclone 3.75 mg at bedtime.
The patient is currently in remission of his MDD and stabilised on escitalopram 20 mg daily. Zopiclone belongs to a new generation of hypnotic drugs along with zolpidem and zaleplon. They are generally termed as the Z-drugs. Zopiclone is a cyclopyrrolone, a class of non-benzodiazepine hypnotic. It is a α-1 isoform selective agonist of GABA-A/benzodiazepine receptors.
Zopiclone involves in allosteric modulation of the GABA-A receptor, thus enhancing the inhibition of GABA and boosting chloride conductance through GABA-regulated channels. Through this action on sleep centre, zopiclone causes sedative hypnotic effects.
- Zopiclone does not distinguish between GABA-A receptors containing different α-subunits (BZ1 and BZ2 phenotype).
- Zopiclone is recommended for the short-term treatment of primary insomnia and insomnia due to psychiatric disturbances.
- The product monograph reported rebound insomnia with sudden discontinuation of zopiclone but not intractable insomnia while on the medication.
Other commonly reported side effect of zopiclone is the so-called ‘hangover effect’ due to delayed elimination, so there may be a prolonged drug effect resulting in residual sedation or the hangover effect. This side effect of zopiclone may be useful for sustained treatment of insomnia with less waking during the night.
This is the opposite in the case of our patient. There may be a possible explanation of drug interactions between zopiclone and antidepressants as our patient was concomitantly on escitalopram and mirtazapine. Zopiclone is metabolised by different microsomal enzymes and a panel of heterologously expressed Cytochrome P-450 isozymes and CYP3A4 is the major enzyme involved in zopiclone metabolism.
The CYP3A4 are inhibitors and inducers and thus have a lesser effect on their bioavailability of antidepressants, and similarly, there is no significant effect of antidepressants on zopiclone metabolism. It is not uncommon to observe paradoxical aggression with the use of benzodiazepines and therefore not entirely surprising for a GABA modulating drug like zopiclone to rarely cause a paradoxical effect.
What happens if you don’t sleep after taking zolpidem?
Zolpidem – What Is Zolpidem? Zolpidem, commonly known as Ambien, slows down activity in the brain, allowing you to sleep. The immediate release form dissolves right away, helping you fall asleep fast. The extended release version has two layers — the first helps you fall asleep, and the second dissolves slowly to help you stay asleep.
It tends to work very quickly — generally within 30 minutes. Studies have confirmed that zolpidem can help initiate the sleep process. Sleep problems often improve within just 7 to 10 days of being on the medication.
Used correctly, zolpidem may be a great option if you need a short-term medication to help you overcome a temporary bout of insomnia. The Drawbacks of Zolpidem If your health care provider prescribes zolpidem, and you take it as directed, zolpidem may help improve your sleep.
Side effects: Like many prescription drugs, zolpidem comes with a list of possible side effects, from dizziness, to constipation, to uncontrollable shaking. Some side effects, such as rash, chest pain, or difficulty breathing can become serious medical concerns that require immediate care. Rarely, Zolpidem can cause unusual nighttime behaviors, such as night-eating or sleep walking. Contact your health care provider immediately if this occurs. Dependency: Zolpidem may be great for short-term insomnia relief, but it is not meant to be used for longer than a few weeks. The drug can be habit-forming, meaning you eventually will have trouble sleeping without it. Next-day impairment: Taking more than the prescribed dosage, or taking zolpidem and then not getting a full night’s sleep (about 7 to 8 hours), can cause problems the next day, like difficulty driving, daytime drowsiness, dizziness, blurred or double vision, reduced alertness, or prolonged reaction time. Drug interactions: Zolpidem can interact with other medications or supplements, which can cause side effects or impact their effectiveness. And vice versa — drugs for other medical conditions or concerns can impact how well zolpidem works. Let your health care provider know what prescription and nonprescription medications, vitamins, herbal products, or nutritional supplements you’re currently taking, as they may need to adjust dosages.
Alcohol can make these side effects worse, so if you’re an active drinker or vacationing at a winery, you may need to steer clear of zolpidem.
How many hours of sleep do you need after taking sleeping pills?
Taking sleeping pills – If your best attempts to get a good night’s sleep have failed, prescription sleeping pills may be an option. Here’s some advice on how to use them safely.
- Get a medical evaluation. Before you take sleeping pills, see your health care provider for a thorough exam. Often your provider may be able to find specific causes for your insomnia. If you’re taking sleeping pills for more than a few weeks, talk to your provider about an appropriate follow-up schedule to discuss your medicines.
- Read the medication guide. Read the medication guide for patients so that you understand how and when to take your medicine and what the major potential side effects are. If you have any questions, ask your pharmacist or health care provider.
- Never take a sleeping pill until you’re going to bed. Sleeping pills can make you less aware of what you’re doing, increasing the risk of dangerous situations. Wait to take your sleeping pill until you’ve completed all of your evening activities, immediately before you plan on sleeping.
- Take your sleeping pill when you can get a full night’s sleep. Only take a sleeping pill when you know you can get a full night’s sleep of at least 7 to 8 hours. A few short-acting sleeping pills are intended for middle of the night awakenings, so you may take them when you can stay in bed for at least four hours.
- Watch for side effects. If you feel sleepy or dizzy during the day or if you experience any other side effects that bother you, talk to your health care provider. Your provider may suggest trying a different medicine, changing your dose or weaning you off pills. Don’t take a new sleeping pill the night before an important appointment or activity because you won’t know how it affects you.
- Avoid alcohol. Never mix alcohol and sleeping pills. Alcohol increases the sedative effects of the pills. Even a small amount of alcohol combined with sleeping pills can make you feel dizzy, confused or faint. Combining alcohol with certain sleeping pills can lead to dangerously slowed breathing or unresponsiveness. And alcohol can actually cause insomnia.
- Don’t take sleeping pills with opioids. Opioids are a wide class of pain-relieving drugs. They include prescription medicines, such as oxycodone, hydrocodone, morphine, methadone and the synthetic opioid fentanyl. This class also includes illegal drugs, such as heroin. Combining an opioid with sleeping pills can be dangerous. The combination increases the sedative effects of the pills and can lead to slowed breathing or unresponsiveness. It can even cause you to stop breathing.
- Take sleeping pills strictly as prescribed by your health care provider. Some prescription sleeping pills are for short-term use only. Be sure to contact your provider for advice. Also, don’t take a higher dose than prescribed. If the initial dose doesn’t produce the intended effect on sleep, don’t take more pills without first talking to your provider.
- Quit carefully. When you’re ready to stop taking sleeping pills, follow your health care provider’s or pharmacist’s instructions or the directions on the label. Some medicines must be stopped gradually. Also, be aware that you may have some short-term rebound insomnia for a few days after you stop taking sleeping pills.
If you continue to have trouble sleeping, ask your health care provider for more help.
Is 7.5 mg of zopiclone strong?
Dosing information –
Adults. The recommended dose in adults is one zopiclone 7.5mg tablet just before bedtime. Elderly – aged over 65 years old. The usual starting dose in elderly patients is one zopiclone low-strength (LS) tablet (3.75 mg) or half a full-strength (7.5 mg) tablet just before bedtime. Your doctor may decide to increase your dose to one 7.5 mg tablet if needed. People with liver or kidney problems. The recommended dose for people with liver and kidney problems is one zopiclone low-strength (LS) tablet (3.75 mg) or half a full-strength (7.5 mg) tablet just before bedtime. Children and adolescents. Zopiclone should not be used in children and adolescents less than 18 years. The safety and efficacy of this medication children and adolescents aged less than 18 years have not been established.
See the full prescribing information for further zopiclone dosing information. Serious side effects of zopiclone include:
Allergic reactions. The signs of an allergic reaction may include:
a rash swallowing or breathing problems swelling of your lips, face, throat or tongue Stop taking this medication and see a doctor or go to the emergency room straight away if you develop symptoms of an allergic reaction.
Tell your doctor as soon as possible if you have any of the following side effects, which are rare or of unknown frequency:
Poor memory (amnesia) since starting this medication. This problem is less likely to occur if you have 7-8 hours of uninterrupted sleep after taking this medication. Seeing or hearing things that are not real (hallucinations) Falling, especially in the elderly Thinking things that are not true (delusions) Feeling low or sad (depressed mood)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Including the following common side effects of zopicolne:
A mild bitter or metallic taste in your mouth or a dry mouth Feeling drowsy or sleepy Dry mouth
Including the following uncommon side effects of zopiclone:
Feeling sick (nausea) or being sick (vomiting) Feeling dizzy or sleepy Headache Nightmares Feeling physically or mentally tired Agitation
Including the following rare side effects of zopiclone:
Feeling confused Itchy, lumpy rash (urticaria) Feeling irritable or aggressive Reduced sex drive Difficulty breathing or being short of breath
Including the following side effects of unknown frequency of zopiclone:
Feeling restless or angry Feeling light headed or having problems with your coordination Double vision Moving unsteadily or staggering Muscular weakness Indigestion Becoming dependent on this medication Slower breathing (respiratory depression) Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia) Mental problems such as poor memory Difficulty paying attention Disrupted normal speech Zopiclone may cause sleepwalking or other unusual behavior (such as driving, eating, making a phone call, or having sex etc.) while not being fully awake.
These are not all of the possible side effects of zopiclone. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Why does zopiclone feel so good?
Why Do You Get Withdrawal Symptoms? – Zopiclone works by increasing the activity of the neurotransmitter GABA. Since GABA is an inhibitory transmitter, which slows or stops the firing of other neurotransmitters, by increasing GABA activity you quiet the brain’s overall activity level.
GABA is the brain’s natural sedative, and zopiclone simply enhances its functioning. GABA suppresses excitatory neurotransmitters like dopamine, serotonin, epinephrine (noradrenaline) and acetylcholine. These excitatory transmitters play important roles in memory, muscle movement, alertness, emotional regulation, heart rate and blood pressure and hormonal secretions.
When taking zopiclone you quiet your whole brain’s activity level. This reduces anxiety and insomnia, but also causes changes to many of the body’s essential systems. This is why taking chronic high doses of zopiclone can cause such a variety of health problems and why people experience such a wide array of withdrawal symptoms after stopping.
Reduce the daily dose by half of a 3.75 mg tablet (1.875 mg) every 2 weeks. The target dose for when to stop is when the person is taking only half of a 3.75 mg tablet.
Please NOTE: because these are potentially drugs of abuse we have a practice policy that lost/stolen scripts are not replaced unless we have a police log and if you over-use and run out we do NOT issue early scripts. By taking these medicines you agree to understand and abide by this rule.
Strive to eat a healthy diet with lots of fresh fruits and vegetables. Drink lots of water Avoid caffeine Exercise (as much as you canyou can’t do too much). MINDset gym and Active4life websites can help with this. Rest up as well as you can Keep a recovery diary and chart the progress you make Ask for help and support from friends or family for things like household chores and general responsibilities If interested, explore alternative healing, such as acupuncture or Chinese medicine Avoid using alcohol or drugs. They may help in the short term but will exacerbate symptoms over the long run Avoid making major decisions or adding unnecessary stress to your life while going through withdrawals Relax in a hot bath Practice relaxation techniques, like deep breathing exercises Meditate and practice mindfulness The Harbour Centre in Plymouth can be really helpful and are on 01752 434343. If sleep is an issue take a look at the Northumberland, Tyne and Weir website on sleeping problems and sleep hygiene ( https://www.cntw.nhs.uk/resource-library/how-to-cope-with-sleep-problems/ )
Often people on zopiclone also struggle with their mental health. There are heaps of services in Plymouth that might help such as:
Plymouth Options on 01752 435419 You can also refer yourself to MIND on 01752 512280. The waits for both services, particularly MIND, is not that long these days. RETHINK on 01752 251072. They also do some group work and 1-2-1 work and are also useful if you physically can’t attend services HEADSPACE Plymouth (tel 07890257614) is a great place for assistance if you are in crisis. Staff and volunteers will be on hand to provide support in both 1:1 and group settings. As well as crisis management, they assist with setting achievable goals and (where appropriate) working with the Wellness Recovery Action Plan.
Our aim is for you to lead as full a life as possible with minimal symptoms and the minimum of harmful medication. From the next script we will support you with the dose reduction suggested above. We hope that you understand the rationale for this and we wish you all the best. Best wishes, Pathfields Medical Group
Does zopiclone only work for 3 hours?
Introduction – Zopiclone is one of the so-called “Z drugs”, along with zolpidem and zaleplon, and was introduced during the second half of the 1980s as a treatment for insomnia. These drugs were developed as safer alternatives to benzodiazepines which can be highly addictive and whose use can lead to dependence.
- Zopiclone was the first compound developed with a different chemical structure to the benzodiazepines but which binds to the same cell receptors as they do.1 It’s often called a short-acting hypnotic because of how quickly it’s eliminated from the body.
- It has a ‘half-life’ of about 5 hours (range of 3.5-6.5 hours), which refers to how long it takes for the concentration of the drug to be reduced by half in the body.
In the elderly, the half-life is slightly longer, at around 7 hours.
Will I wake up on zopiclone?
Zopiclone is used to treat short-term sleep problems or insomnia. It helps you fall asleep more quickly, and also helps stop you waking up during the night. It works on chemicals in your brain to make you relaxed and sleepy.
Does zopiclone make it hard to wake up?
Common questions about zopiclone How does zopiclone work?
- Zopiclone boosts the effectiveness of a chemical in the brain called gamma-aminobutyric acid (GABA).
- GABA blocks transmission across nerves in the brain and has a calming effect.
- By boosting the effectiveness of GABA, zopiclone improves sleep.
How long does it take to work? Zopiclone takes around 1 hour to work. Can I get addicted to zopiclone? If you just take it for up to 4 weeks, you’re unlikely to become addicted to zopiclone. You may become dependent on it if you take it for longer than 4 weeks.
- Do not suddenly stop taking this medicine without telling your doctor, as you may get withdrawal symptoms.
- This is when, for a few days or weeks, your insomnia comes back and is worse than before.
- You may also feel anxious or restless, have mood changes, and become very sensitive to light, noise and being touched.
Speak to your doctor about coming off zopiclone. They may suggest that you reduce your dose slowly, over a few days or weeks, to prevent withdrawal symptoms. But if you’ve been taking zopiclone for less than a month, you’re unlikely to have any of these symptoms. How long will it stay in my system?
- Zopiclone does not stay in your system for more than about 12 hours.
- But some people feel sleepy the next morning when they wake up.
- If this happens to you, do not do any activities that need you to be fully alert, such as driving, cycling, or using tools or machinery.
Will I sleepwalk with zopiclone? Some people have reported doing things like, making food and making phone calls while they’re asleep after taking zopiclone. They do not remember when they wake up. This is more likely to happen if you take zopiclone with alcohol or other medicines for mental health problems like or,
If this happens to you, go back to your doctor for advice. Will it affect my contraception? Zopiclone does not affect how any type of contraception works, including the and, Can I drive or ride a bike? Do not drive a car, ride a bike or operate machinery if zopiclone makes you sleepy during the daytime, gives you blurred vision, or makes you feel dizzy, clumsy or unable to concentrate or make decisions.
This may be more likely when you first start taking zopiclone, but could happen at any time, for example, when starting another medicine. It’s an offence to drive a car if your ability to drive safely is affected. It’s your responsibility to decide if it’s safe to drive.
- If you’re in any doubt, do not drive.
- Talk to your doctor or pharmacist if you’re unsure whether it’s safe for you to drive while taking zopiclone.
- Can I drink alcohol with it? No.
- Do not drink alcohol while you’re on zopiclone.
- Alcohol and zopiclone together can make you sleep very deeply, so you do not breathe properly and can have difficulty waking up.
Is there any food or drink I need to avoid? Do not have drinks that contain caffeine, like coffee, tea, cola or energy drinks, while you’re on zopiclone. Caffeine has the opposite effect of zopiclone in your body and stops it working. Will recreational drugs affect it? Using cannabis with zopiclone will make its sleep-inducing effects worse.
You could go into a very deep sleep, where you have difficulty waking up. Using heroin or with zopiclone may also increase the sedative effects of both of them. Again, you could go into a very deep sleep and have difficulty waking up. Talk to your doctor if you think you might use recreational drugs while you’re taking zopiclone.
You can find out more the side effects of some recreational drugs on the, Can lifestyle changes help with insomnia? There are a number of things you can do to help with and :
- set regular times for going to bed and waking up
- relax before bedtime – try taking a warm bath or listening to calming music
- use thick curtains or blinds, an eye mask and earplugs to stop you being woken up by light and noise
- avoid caffeine, cigarettes, vaping, alcohol, heavy meals and exercise for a few hours before going to bed
- do not watch TV or use phones, tablets or computers just before going to bed
- do not nap during the day
- write a list of your worries, and any ideas about how to solve them, before you go to bed to help you forget about them until the morning
Some people find sleeping tablets you can buy in a pharmacy helpful, as an alternative to prescription medicines such as zopiclone. They cannot cure insomnia and they can have unwanted side effects, but they may help you sleep better for 1 to 2 weeks.
Can you take 2 zopiclone at once?
4.2 Dose and method of administration Zopiclone Actavis should be taken in a single intake and not be readministered during the same night. Adults 7.5 mg by oral administration shortly before retiring. This dose should not be exceeded.
Why doesn’t zopiclone make me sleepy?
How long to take it for – You’ll usually be prescribed zopiclone for just 2 to 4 weeks. This is because your body gets used to this medicine quickly, and after this time it’s unlikely to have the same effect. Your body can also become dependent on it. Do not stop taking zopiclone suddenly without speaking to your doctor.
They may suggest you reduce your dose slowly to prevent withdrawal symptoms. However you’re unlikely to have withdrawal symptoms if you’ve been taking it for less than a month. If you still have sleeping problems after finishing your course of zopiclone, try lifestyle changes to help you get to sleep.
See your doctor again if these do not help.
What can you not mix with zopiclone?
Zopiclone and other medicines – Tell your GP or pharmacist if you are taking any other medicines. This includes herbal remedies, vitamins or supplements. Some medicines and zopiclone can interfere with each other. This can increase your chance of side effects. Talk to your GP or pharmacist if you are taking medicines for:
- schizophrenia and
- surgery (anaesthetics)
- sleep problems, anxiety or to calm you
- hay fever, rashes, or other allergies that can make you sleepy
- pain such as codeine, methadone, morphine, oxycodone, pethidine, or tramadol
- infections, including the antibiotics erythromycin or clarithromycin
- fungal infections, such as ketoconazole and itraconazole
- HIV, such as ritonavir
Taking zopiclone with codeine, methadone, morphine, oxycodone, pethidine, or tramadol may increase the risk of side effects. This can lead to dependency. It may also increase the risk of drowsiness and difficulties in breathing. This may lead to coma and could be life-threatening.
Is there a stronger sleeping pill than zopiclone?
BRIEF SUMMARY – Current Knowledge/Study Rationale: Good sleep management will improve quality of life outcomes for patients with insomnia and/or pain. Sleep medications may cause adverse effects, but clonidine may offer better qualities for sleep management.
What is the minimum sleep for zolpidem?
Zolpidem – Zolpidem is a sedative-hypnotic type medication used for the treatment of insomnia in adults. It comes in both immediate and extended-release forms; the immediate release preparations are used to treat symptoms related to delayed sleep onset.
The extended-release preparation treats both delayed sleep onset and decreased sleep latency. For immediate release formulations, women should be started on a dose of 5mg and men with 5 or 10mg immediately before bedtime. Women should begin with 6.25mg and men with 6.25mg or 12.5mg if using extended-release formulations.
In patients 65 years or older, the minimum dose should be used to minimize adverse effects, not exceeding 5mg for immediate release and 6.25mg for extended release. Zolpidem should only be used for short-term treatment of insomnia and should only be taken when the patient has 7 to 8 hours to sleep before being active again.
Caution should be used when prescribing this medication to patients taking other drugs, especially medicines for seizures, sleep, anxiety, muscle relaxants, or opioids.22 Pregnant women should only be prescribed zolpidem when potential benefits outweigh potential risks to the fetus as there are no adequate and well-controlled studies of use in pregnant women.
For elderly or debilitated patients, the risk of impaired motor or cognitive performance is higher, and patients should be monitored more closely. All patients, regardless of age, should be monitored for adverse effects once therapy is initiated, specifically for the remission of insomnia symptoms, abnormal thinking or behavioral changes, or severe reactions such as anaphylaxis.
Can I take zolpidem at 2am?
Proper Use – Drug information provided by: Merative, Micromedex ® Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).
- This medicine should come with a Medication Guide.
- Read and follow the instructions carefully.
- Ask your doctor if you have any questions.
- Take zolpidem just before going to bed, when you are ready to go to sleep or when you are having trouble falling asleep.
- This medicine works very quickly to put you to sleep.
Swallow the extended-release tablet and capsule whole. Do not open, divide, crush, or chew it. Do not take this medicine when your schedule does not permit you to get a full night’s sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.
Can I take another zolpidem if I wake up?
Before taking zolpidem, –
- tell your doctor and pharmacist if you are allergic to zolpidem, any other medications, or any of the ingredients in the zolpidem product you are using. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants (‘mood elevators’) including imipramine (Tofranil) and sertraline (Zoloft); chlorpromazine; itraconazole (Onmel, Sporanox); ketoconazole (Nizoral); medications for anxiety, colds or allergies, mental illness, pain, or seizures; rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- you should not take more than one sleeping pill on the same night. If you have taken a zolpidem product or a different type of sleeping pill at bedtime and you wake up in the middle of the night, you should not take a zolpidem sublingual tablet (Intermezzo) or any other sleeping pill.
- tell your doctor what herbal products you are taking, especially St. John’s wort.
- tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had depression; mental illness; thoughts of harming or killing yourself or trying to do so; a problem with heavy snoring; sleep apnea (condition in which breathing briefly stops many times during the night); other breathing problems or lung diseases such as asthma, bronchitis, and emphysema; myasthenia gravis (condition that causes weakness of certain muscles); or kidney or liver disease.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, plan to become pregnant, or are breastfeeding. If you become pregnant while taking zolpidem, call your doctor.
- talk to your doctor about the risks and benefits of taking zolpidem if you are 65 years of age or older. Older adults should not usually take zolpidem because it is not as safe or effective as other medications that can be used to treat the same condition.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking zolpidem.
- you should know that zolpidem may cause drowsiness, decreased mental alertness, prolonged reaction time, problems with coordination the day after you take it, and may increase the risk that you could fall. Take extra care to be sure you do not fall, especially if you get out of bed in the middle of the night. Your ability to drive or operate machinery the day after you take zolpidem may be impaired even if you feel fully awake. Do not drive a car or operate machinery the day after you take an extended-release zolpidem product. Talk to your doctor about the risks of driving or operating machinery the day after you take any other zolpidem products.
- do not drink alcohol during your treatment with zolpidem. Alcohol can make the side effects of zolpidem worse.
- you should know that your behavior and mental health may change in unexpected ways while you are taking this medication. It is hard to tell if these changes are caused by zolpidem or if they are caused by physical or mental illnesses that you may already have or suddenly develop. Tell your doctor right away if you experience any of the following symptoms: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, difficulty concentrating, anxiety, becoming easily agitated, slowed speech or movements, new or worsening depression, thinking about killing yourself or trying to do so, confusion, and any other changes in your usual thoughts, mood, or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.
Unless your doctor tells you otherwise, continue your normal diet. This medication is taken as needed. You may take zolpidem even if it is later than the usual time, as long as you will be able to remain in bed for the required number of hours after you take it.
How many zopiclone 7.5 mg can I take?
My Account Area – 1. Name of the medicinal product Zopiclone 7.5 mg film-coated tablets 2. Qualitative and quantitative composition Zopiclone 7.5 mg film-coated tablets: Each film-coated tablet contains 7.5 mg zopiclone. Excipient with known effect: Each film-coated tablet contains 80.00 mg lactose monohydrate. Each 7.5 mg film-coated tablet contains 0.13 mg sodium. For the full list of excipients, see section 6.1.3. Pharmaceutical form Film-coated tablet Zopiclone 7.5 mg film-coated tablets: White, round, (diameter: 7.6mm), biconvex film coated tablets debossed with ‘Z & 2’ separated with break line on one side and break line on the other side. The tablet can be divided into equal doses.4. Clinical particulars 4.1 Therapeutic indications Short-term treatment of insomnia in adults, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient. Long term continuous use is not recommended. A course of treatment should employ the lowest effective dose.4.2 Posology and method of administration Use the lowest effective dose. Zopiclone should be taken in a single intake and not be re-administered during the same night. Treatment should be as short as possible. Posology Adults The recommended dose for adults is 7.5 mg (two tablets of 3.75 mg or one tablet of 7.5 mg) by the oral route shortly before retiring. Elderly A lower dose of 3.75mg zopiclone should be employed to start treatment in the elderly. Depending on effectiveness and acceptability, the dosage subsequently may be increased if clinically necessary. Patients with hepatic insufficiency: As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower dose of 3.75mg zopiclone nightly is recommended. The standard dose of 7.5mg zopiclone may be used with caution in some cases, depending on effectiveness and acceptability. Renal insufficiency: Although no accumulation of zopiclone or its metabolites have been found in patients with renal insufficiency, it is advisable to begin treatment of patients with reduced renal function at 3.75 mg. Chronic respiratory insufficiency In patients with chronic respiratory insufficiency, a starting dose of 3.75 mg zopiclone is recommended initially. The dosage subsequently may be increased to 7.5 mg. Paediatric population: Zopiclone should not be used children and adolescents less than 18 years. The safety and efficacy of zopiclone in children and adolescents aged less than 18 years have not been established. Treatment duration Transient insomnia 2 – 5 days. Short term insomnia 2 – 3 weeks. A single course of treatment should not continue for longer than 4 weeks including any tapering off., Extension beyond the maximum treatment period should not take place without reevaluation of the patient’s status since the risk of abuse and dependence increases with the duration of treatment (see section 4.4). The product should be taken just before retiring for the night. Method of administration For oral use. Each tablet should be swallowed without sucking, chewing or breaking.4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Myasthenia gravis • Respiratory failure • Severe sleep apnoea syndrome • Children and adolescents under 18 years of age • Severe hepatic insufficiency • Who have previously experienced complex sleep behaviours after taking zopiclone, see section 4.4 4.4 Special warnings and precautions for use The cause of insomnia should be identified wherever possible and the underlying factors treated before a hypnotic is prescribed. The lack of relief from insomnia after 7-10 days of treatment indicates possibly the presence of a primary psychiatric and / or medical pathology or the presence of an erroneous perception of the state of sleep Specific patient groups Use in hepatic insufficiency: A reduced dosage is recommended, see Posology. Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy (see section 4.3 contraindications). Use in renal insufficiency : A reduced dosage is recommended, see Posology. Use in respiratory insufficiency: As hypnotics have the capacity to depress respiratory drive, precautions should be observed if zopiclone is prescribed to patients with compromised respiratory function (see section 4.8). A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Use in Paediatric population: Zopiclone should not be used children and adolescents less than 18 years. The safety and efficacy of zopiclone in children and adolescents aged less than 18 years have not been established. Use in Elderly patients Elderly should be given a reduced dose (see section 4.2). Due to the muscle relaxant effect of zopiclone, there is a risk of fall, especially in the elderly if they get up during the night. Risk of dependence: Clinical experience to date with Zopiclone suggests that the risk of dependence is minimal when the duration of treatment is limited to not more than 4 weeks. The use of benzodiazepines and benzodiazepine-like substances (even at therapeutic doses) can lead to the development of physical and psychological dependence or abuse upon these products. The risk of dependence or abuse increases the higher the dose and the longer the period of treatment; the risk of dependence or abuse is also greater in patient with a history of alcohol or other pshychotropics or drug abuse or those who have marked personality disorders. The decision to use a hypnotic in such patients should be taken only with this clearly in mind. If physical dependence occurs, sudden discontinuation of the treatment will be accompanied by withdrawal symptoms (see warnings and precautions). These may be expressed as headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise or physical contact, hallucinations or epileptic seizures. Rare cases of abuse have been reported. Withdrawal The termination of treatment with Zopiclone is unlikely to be associated with withdrawal effects when duration of treatment is limited to 4 weeks. Patients may benefit from tapering of the dose before discontinuation. (See also section 4.8. Undesirable Effects). Depression: As with other hypnotics, zopiclone does not constitute a treatment for depression and may even unmask its symptoms (suicide may be precipitated in such patients). Any underlying cause of insomnia should be addressed carefully before symptomatic treatment to avoid under treating potentially serious effects of depression. Suicidal tendencies maybe present, therefore the least amount of zopiclone that is feasible should be supplied to these patients to avoid the possibility of intentional overdose by the patient. Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists. Suicidality: Some epidemiological studies indicate an increased incidence of suicide and suicide attempts in patients with or without depression, and treated with benzodiazepines or hypnotics, including zopiclone. However, a causal association has not been demonstrated. Rebound insomnia A transient syndrome where the symptoms which led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form on discontinuation of therapy. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal/rebound phenomena is increased after prolonged treatment, or abrupt discontinuation of therapy, it is, therefore, recommended to decrease the dosage gradually and to advise the patient accordingly. A course of treatment should employ the lowest effective dose for the minimum length of time necessary for effective treatment. See posology for guidance on possible treatment regimen. A course of treatment should not continue for longer than 4 weeks including any tapering off (see section 4.8). Tolerance Some loss of efficacy to the hypnotic effect of benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. However, with zopiclone there is an absence of any marked tolerance during treatment periods of up to 4 weeks. Amnesia Anterograde amnesia may occur, especially when sleep is interrupted or when retiring to bed is delayed after taking the tablet. Therefore to reduce the possibility of anterograde amnesia, patients should ensure that they take the tablet when certain of retiring for the night and they are able to have a full night’s sleep (uninterrupted sleep of about 8 hours). Psychomotor impairment Like other sedative/hypnotic drugs, zopiclone has CNS-depressant effects. The risk of psychomotor impairment, including impaired driving ability, is increased if: zopiclone is taken within 12 hours of performing activities that require mental alertness, a dose higher than the recommended dose is taken, or zopiclone is co-administered with other CNSdepressants, alcohol or with other drugs that increase the blood levels of zopiclone (see section 4.5). Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle following administration of zopiclone and in particular during the 12 hours following that administration. Other Psychiatric and paradoxical reactions Other psychiatric and paradoxical reactions have been reported (see section 4.8 Undesirable effects), like restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, inappropriate behaviour and other adverse behavioural effects are known to occur when using sedative/hypnotic agents like zopiclone. Should this occur, use of zopiclone should be discontinued. These reactions are more likely to occur in the elderly. Somnambulism and associated behaviours Complex sleep behavior, including sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, or making phone calls, with amnesia for the event, have been reported in patients who have taken zopiclone and were not fully awake. These events may occur following the first or any subsequent use of zopiclone. The use of alcohol and other CNS-depressants with zopiclone appears to increase the risk of such behaviours, as does the use of zopiclone at doses exceeding the maximum recommended dose. Discontinuation of zopiclone should be strongly considered for patients who report such behaviours (see section 4.3). Risk from concomitant use of opioids: Concomitant use of zopiclone and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Zopiclone with opioids should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe zopiclone concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to be aware of these symptoms (see section 4.5). Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance,total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Zopiclone contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.4.5 Interaction with other medicinal products and other forms of interaction Association not recommended: Concomitant use with alcohol is not recommended because the sedative effect of zopiclone may be intensified when used in combination with alcohol. In particular, this may affect the ability to drive or operate machines. Associations to be taken in to account: In combination with CNS depressants an enhancement of the central depressive effect may occur. The therapeutic benefit of co-administration with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines should therefore be carefully weighed. In the case of narcotic analgesics, enhancement of euphoria may also occur leading to an increase in psychic dependence. Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines and benzodiazepine-like agents. Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines and benzodiazepine-like agents. Since zopiclone is metabolised by P450 (CYP)3A4 isoenzyme (see section 5.2 Pharmacokinetic Properties), the plasma levels of zopiclone and thus the effect of zopiclone may be increased when used in combination with drugs which inhibit CYP3A4, such as such as erythromycin, clarithromycin, azole antimycotics such as ketoconazole, itraconazole and ritonavir. Dose reduction should be considered if zopiclone is co-administered with CYP3A4 inhibitors. Co-administration with Drugs which induce CYP3A4, like phenobarbital, phenytoin, carbamazepine, rifampicin and products containing St John’s wort, may reduce zopiclone plasma levels and thus the effect of zopiclone. A dose increase for zopiclone may be required when it is co-administered with CYP3A4 inducers. The effect of erythromycin on the pharmacokinetics of zopiclone has been studies in 10 healthy subjects. The AUC of zopiclone is increased by 80% in presence of erythromycin which indicates that erythromycin can inhibit the metabolism of drugs metabolised by CYP 3A4. As a consequence, the hypnotic effect of zopiclone may be enhanced. Opioids: The concomitant use of sedative medicines such as benzodiazepines or related drugs such as Zopiclone with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dosage and duration of concomitant use should be limited (see section 4.4).4.6 Fertility, pregnancy and lactation Pregnancy Zopiclone should not be used during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Zopiclone crosses the placenta. A large amount of data on pregnant women (more than 1000 pregnancy outcomes) collected from cohort studies has not demonstrated evidence of the occurrence of malformations following exposure to benzodiazepines or benzodiazepine like substances during the first trimester of pregnancy. However, certain case-control studies reported an increased incidence of cleft lip and palate associated with use of benzodiazepines during pregnancy. Cases of reduced fetal movement and fetal heart rate variability have been described after administration of benzodiazepines or benzodiazepine-like substances during the second and/or third trimester of pregnancy Moreover, if zopiclone is prescribed during the last three months of pregnancy or during labour, due to the pharmacological action of the product, effects on the neonate, such as hypothermia, hypotonia, feeding difficulties ( floppy infant syndrome ) and respiratory depression can be expected due to the pharmacological action of the product. Cases of severe neonatal respiratory depression have been reported. Infants born to mothers who took benzodiazepines or benzodiazepine-like agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended. If the product is prescribed to a woman of child bearing potential, she should be advised to contact her physician about stopping the product if she intends to become pregnant, or suspects that she is pregnant, Breast feeding Zopiclone is excreted in breast milk, although the concentration of zopiclone in the breast milk is low, use in nursing mothers must be avoided. Fertility In a double-blind long-term study on healthy male volunteers, no negative changes in sperm volume, sperm concentration, sperm motility and cell morphology were found in spermatograms at doses of 7.5 mg zopiclone over a period of 84 days.4.7 Effects on ability to drive and use machines Because of its pharmacological properties and its effect on central nervous system, Zopiclone may adversely affect the ability to drive or to use machines. The risk of psychomotor impairment, including impaired driving ability, is increased if: • zopiclone is taken within 12 hours of performing activities that require mental alertness, • a dose higher than the recommended dose is taken, or • zopiclone is co-administered with other CNS depressants, alcohol, or with other drugs that increase the blood levels of zopiclone. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle following administration of zopiclone and in particular during the 12 hours following that administration.4.8 Undesirable effects The following CIOMS frequency rating is used, when applicable: Frequency estimate: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (<1/10,000); not known (cannot be estimated from the available data). Immune system disorders
|Very Rare:||angiooedema, anaphylactic reaction, Stevens-Johnson syndrome, toxic epidermal necrosis, erythema multiforme.|
|Rare:||confusional state, libido disorder, irritability, aggression, hallucination|
|Not known:||restlessness, delusion, anger, depressed mood, abnormal behaviour (possibly associated with amnesia) and complex sleep behavior including somnambulism (see Section 4.4: somnambulism and associated behaviour), dependence (see Section 4.4), withdrawal syndrome (see below)|
Nervous system disorders
|Common:||dysgeusia (Bitter taste), somnolence (residual)|
|Not known:||Ataxia, paraesthesia, cognitive disorders such as memory impairment, disturbance in attention, speech disorder|
Eye disorders Respiratory, thoracic and mediastinal disorders
|Rare:||dyspnoea (see section 4.4)|
|Not known:||respiratory depression (see section 4.4)|
|Very rare:||transaminases increased and/or blood alkaline phosphatase increased (mild to moderate)|
Skin and subcutaneous tissue disorders
|Rare:||urticaria or rash, pruritus|
Musculoskeletal and connective tissue disorders
|Not known:||muscular weakness|
General disorders and administration site conditions
|Not known:||light headedness, incoordination Injury, poisoning and procedural complications|
|Rare:||fall (predominantly in elderly patients)|
Injury, poisoning and procedural complications
|Rare:||fall (predominantly in elderly patients)|
Withdrawal syndrome has been reported upon discontinuation of zopiclone. (See section 4.4. Special Warnings and Precautions for Use). Withdrawal symptoms vary and may include rebound insomnia, muscle pain,anxiety, tremor, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations, panic attacks, muscle aches/cramps, gastrointestinal disturbances and irritability.
In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations. In very rare cases, seizures may occur. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose Fatal dose not known.
Symptoms In the cases of overdosage reported,Overdose is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma according to the quantity ingested. In mild cases, symptoms include drowsiness, confusion and lethargy; in more severe cases, symptoms may include ataxia, hypotonia, hypotension, methaemoglobinaemia, respiratory depression, and coma.
Overdose should not be life threatening unless combined with other CNS depressants, including alcohol. Other risk factors, such as the presence of concomitant illness and the debilitated state of the patient, may contribute to the severity of symptoms and very rarely can result in fatal outcome.
Management Symptomatic and supportive treatment in adequate clinical environment is recommended, attention should be paid to respiratory and cardiovascular functions. Consider activated charcoal if an adult has ingested more than 150 mg or a child more than 1.5 mg/kg within one hour. Alternatively, consider gastric lavage in adults within one hour of a potentially life threatening overdose.
Hemodialysis is not effective because it is high zopiclone distribution volume If CNS depression is severe consider the use of flumazenil. It has a short half-life (about an hour). NOT TO BE USED IN MIXED OVERDOSE OR AS A “DIAGNOSTIC” TEST. Management should include general symptomatic and supportive measures including a clear airway and monitoring cardiac and vital signs until stable.5.
- Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: hypnotic-sedative.
- ATC code N05C F01 Mechanism of action: Zopiclone is a benzodiazepine-like hypnotic agent which belongs to the group of cyclopyrrolones.
- It rapidly initiates and sustains sleep without reduction of total REM sleep and with preservation of slow wave sleep.
Negligible residual effects are seen the following morning. The pharmacological properties are: hypnotic, sedation, anxiolysis, anticonvulsion, muscle relaxation. These effects are related to a specific agonistic effect on central receptors belonging to the GABAA, macromolecular complex which regulates the opening of chloride channels.
- However, it has been shown that zopiclone and other cyclopyrrolones act on a different site to those of benzodiazepines including different conformational changes in the receptor complex.
- Pharmacodynamic effects Zopiclone has been found to increase the duration of sleep and improve the quality of sleep, reduce the nightly and early morning awakenings in humans.
This activity is supplemented by characteristic results of electroencephalography. Sleep registration has proven that zopiclone decreases the phase-one sleep and increases the phase-two sleep, while maintaining and lengthening the deep sleep phases (III and IV) and does not affect the paradoxical (REM) sleep in patients suffering from insomnia.5.2 Pharmacokinetic properties Absorption Zopiclone is swiftly absorbed.
- Maximum plasma concentrations are achieved after 1½ – 2 hours and are approximately 30 and 60 ng/ml after administration of 3.75 mg and 7.5 mg respectively.
- Absorption is the same in men and women and is not affected by simultaneous ingestion of food or repetition of doses.
- Distribution Zopiclone is swiftly distributed from the vascular compartment.
The plasma protein binding is at least 45% and is not saturable. There is very little risk of drug interactions due to protein binding. The volume of distribution is 91.8 – 104.6 litres. The decrease in plasma level does not depend on the dose between 3.75 and 15 mg.
No accumulation occurs after repeated administration and individual differences appear slight. During lactation, zopiclone kinetics in plasma and milk are similar, the milk/plasma ratio of zopiclone was about 0.5 and remained constant over time and the maximum zopiclone concentration in milk was found between 1 and 6 hours following maternal administration.
It is estimated that the infant can consume no more than 1.0% of the maternal dose in 24 hours with human milk. Biotransformation The most important metabolites are the N-oxide derivative (pharmacologically active in animals) and the N-desmethyl metabolite (pharmacologically inactive in animals).
An in-vitro study indicates that cytochrome P450 (CYP) 3A4 is the major isoenzyme involved in the metabolism of zopiclone to both metabolites, and that CYP2C8 is also involved with N-desmethyl zopiclone formation. Their apparent half-life times are approximately 4.5 hours and 1.5 hours respectively. No significant accumulation of the compound is seen following repeat dosing, (15mg) for 14 days.
In animals, no enzyme induction has been observed even at high doses. Elimination The low renal clearance of zopiclone (on average 8.4 ml/min) compared to the plasma clearance (232 ml/min) shows that zopiclone is cleared chiefly by metabolism. Zopiclone is eliminated in the urine (approximately 80%) in the form of unconjugated metabolites (N-oxide and N-desmethyl derivatives) and in the faeces (approximately 16%).The elimination half-life of unchanged zopiclone at recommended doses is approximately 5 hours.
- Special patient groups In various trials with elderly patients, no accumulation of zopiclone was observed in the plasma after repeated doses, in spite of a slight reduction in the renal function and extension of the elimination half-life to approximately 7 hours.
- In renal insufficiency, no accumulation of zopiclone or its metabolites have been detected after prolonged administration.
Zopiclone crosses the dialysing membrane. However, in the event of an overdose, hemodialysis is not effective in the event of an overdose due to the large volume of distribution of zopiclone and the low molecular weight (see section 4.9). In patients with cirrhosis of the liver the plasma clearance of zopiclone is reduced by approximately 40% due to a decrease of the demethylation process and an extended half-life of about 8 hours is observed.
- For this reason the initial dosage should be reduced for these patients.5.3 Preclinical safety data Chronic toxicity Hepatotoxic effects were elicited in repeated dose toxicity studies conducted in rats and dogs.
- In dogs anaemia were evident in some studies.
- Mutagenicity and carcinogenicity Zopiclone did not show a mutagenic potential in vitro and in vivo.
An increased incidence of mammary carcinomas in female rats at high multiples of the maximum plasma concentration of therapeutic doses in humans have been attributed to elevated serum levels of 17-beta-estradiol. An increased incidence of thyroid tumors in rats has been attributed to elevated TSH serum levels.
In humans, zopiclone has no effects on thyroid hormones. Reproduction toxicity Fertility was reduced in two rat studies, while zopiclone did not adversely affect fertility in rabbits.Foetal developmental retardations and foetotoxic effects in rats and rabbits were observed only at doses well above the maximum human dosage.
There was no evidence of a teratogenic potential.6. Pharmaceutical particulars 6.1 List of excipients Tablet core: Lactose monohydrate Calcium hydrogen phosphate dihydrate Starch, Pre-gelatinized (Maize Starch) Povidone (K-30) Sodium starch glycolate (Type A) Magnesium Stearate Tablet coat: Hypromellose (6cps) Macrogol Titanium Dioxide (E171) 6.2 Incompatibilities Not applicable.6.3 Shelf life 3 years 6.4 Special precautions for storage This medicinal product does not require any special storage conditions.6.5 Nature and contents of container Zopiclone film-coated tablets are available in white opaque PVC-Aluminium blister pack.
Pack sizes: Blister packs: 5, 10, 14, 20, 28, 30, 50, 60 and 90 film-coated tablets Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.7. Marketing authorisation holder Milpharm Limited Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom 8.
Marketing authorisation number(s) PL 16363/0542 9. Date of first authorisation/renewal of the authorisation 10. Date of revision of the text 17/02/2022
What are the top three sleeping pills?
Sleeping Pills for Insomnia: What You Should Know About Lunesta, Ambien, and Sonata. Key takeaways: Ambien, Lunesta, and Sonata are three non-benzodiazepine medications used to help with sleep. The medications are similar in how well they work and their side effects.
Can you drink alcohol and take a sleeping pill?
Side Effects of Mixing Sleeping Pills and Alcohol – Because there are so many different types of sleeping pills, their exact interactions with alcohol may differ slightly, with some being more dangerous than others. In general, it is advised to never mix sedatives or hypnotics with alcohol.
Drowsiness. Dizziness. Memory problems. Confusion/disorientation. Unusual behavior. Impaired motor control. Slowed heart rate. Lowered blood pressure. Slowed or difficulty breathing. Increased risk of overdose, Death.
Drinking even one alcoholic beverage in combination with sleeping pills can be dangerous. Some sleeping pills have adverse and/or unusual effects such as memory loss and sleepwalking, even when taken on their own.3,4 People have reported engaging in behaviors such as eating, talking on the phone, and sometimes even driving a motor vehicle with no recollection after taking a sleeping pill.5
Can a person wake up after taking sleeping pills?
Is it hard to wake up after taking sleeping pills? – Sleeping pills are not anesthetics. Most of the time, you would wake up naturally after taking them. However, it is important to time your sleep medicine properly to allow a full seven to eight hours of sleep. If you take a sleeping pill and wake up after only a few hours, you will likely feel groggy, off-balance, and confused.
What not to do after taking sleeping pills?
Don’t mix over-the-counter (OTC) or prescription sleep medicines with alcohol or other drugs that depress the nervous system.7. Don’t drive a car or operate machinery after taking any kind of sleep product.
How long should you wait to lay down after taking a pill?
When is it best to sit or stand? – Sometimes your pharmacist may advise you to swallow your medicine sitting, standing, or lying down for reasons other than speeding up absorption. For example, certain drugs are more likely to cause side effects such as heartburn, where stomach acid leaks from the stomach and moves up into the oesophagus (food pipe). Some medicines can irritate the throat or cause heartburn. So it’s best to take these upright. Shutterstock Some medicines can irritate the throat if they become stuck. This is because they damage the protective mucosal barrier that lines your oesophagus and stomach, causing irritation and inflammation.
How easy is it to wake up after taking sleeping pills?
How to Use Sleep Medications Safely are one of the most common treatments for insomnia National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.
Used properly, they can be a helpful way of drifting off on nights when sleep is difficult. Unfortunately, studies have found that many people develop unsafe habits National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.
regarding sleep aids. By working with a doctor and understanding the risks associated with sleep medications, you can minimize your chances of unwanted side effects. Sleep medications are only one part of an overall treatment plan for, Because they can be addictive and they often come with side effects, the American College of Physicians National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.
- And the American Academy of Sleep Medicine recommend using other techniques before turning to pharmaceutical sleep aids.
- Cognitive behavioral therapy National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.
for insomnia (CBT-I) is the preferred first line of treatment. Your health provider can help you work through stress, anxiety, or other emotions that may be affecting your sleep. They can also teach you habits that can lead to long-lasting benefits for sleep.
- That said, for some people, a short-term course of pharmaceutical sleep aids may help in developing these healthy behaviors and learning to manage insomnia.
- Many sleep problems are actually due to an undiagnosed sleep disorder or medical condition.
- Conducting a sleep study or other tests can shed light on these problems, which may need to be treated along with the insomnia itself.
You should always talk to your doctor before starting a new kind of medication. Even over-the-counter sleep aids and herbal supplements carry potential risks. A thorough discussion with a healthcare professional can help you decide if the benefits outweigh the risks.
There are many, Before prescribing a specific sleeping pill, your doctor will take note of existing mental or physical health concerns and ensure that the sleep aid will not interact with any medications, recreational drugs, or herbal remedies you are currently taking. You should also confirm that you are not allergic to any ingredients in the sleep aid.
Different sleep aids may help you fall asleep faster, reduce nighttime awakenings, or sleep for longer. Your doctor will choose a short-acting or long-acting sleep aid based on what is more appropriate for your situation. Experts recommend taking the lowest dose possible to reduce potential side effects.
- If you have a sleep disorder that can be treated with a specific type of sleep aid, your doctor will also take this into account.
- Once your doctor chooses a sleep aid, you should read the pamphlet carefully, follow your doctor’s instructions on dosage and timing, and ask any relevant questions.
- Avoid starting treatment right before an important event, in case the medication causes unexpected side effects.
Most sleep aids are designed to be effective during four or eight hours. Taking a pill when you need to wake up before this time may cause next-day grogginess. For people who have trouble falling asleep but sleep soundly once they are asleep, it may be more appropriate to use a shorter-acting sleep aid.
- Experts advise against taking sleeping pills before driving or doing other activities that require your full attention.
- This also applies to cases where you might need to wake up during the night, such as if you are caring for a dependent person.
- Sleep aids should be taken right before bedtime, as taking them too early in the evening may interfere with evening activities.
Keep in mind that some sleeping pills will take longer to kick in if taken with food. It may take a few nights before you start to see improvements to your sleep, so don’t change your dose without first talking to your doctor. Some sleep medications can cause rebound insomnia if they are stopped too suddenly. Most experts agree that sleep aids should not be used long-term. Sleeping pills are best used for short-term stressors, jet lag, or similar sleep problems. There is limited evidence on the safety and efficacy of using sleep aids for more than four weeks, but some studies have found that daily use of sleep aids may be linked to a higher risk of mortality National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.
- Sleep aids may also affect sleep stages National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.
- With corresponding effects on sleep quality.
- Many people develop a tolerance to sleep aids, meaning they need higher doses of the drug over time to get the same effects.
This may be accompanied by addiction or withdrawal symptoms, including rebound insomnia, anxiety, irritability, or strange dreams. For people with insomnia that resists other forms of treatment, doctors may give you prescription sleeping medication to be taken regularly.
To lower the risk of developing tolerance or addiction, doctors may prescribe these long-term sleep aids for only a few nights a week. OTC sleep aids are not intended for long-term use. Many people use sleeping pills with no major problems. However, virtually all sleep aids currently on the market do come with potential, such as next-day grogginess, nausea, and headaches.
Taking the lowest dose possible may help limit these side effects. Physicians also suggest people avoid taking sleep aids on nights before they may need to make big decisions. More rarely, you may experience more serious effects Merck Manual First published in 1899 as a small reference book for physicians and pharmacists, the Manual grew in size and scope to become one of the most widely used comprehensive medical resources for professionals and consumers.
- Rebound Insomnia: It’s common to experience a short bout of insomnia after you stop taking sleep aids, even if you only used them for a short time. Where possible, most doctors recommend weaning yourself off the medication by gradually lowering your doses.
- Complex Sleep Behaviors: In rare cases, sleep medications may cause people to carry out activities while not fully conscious, such as driving National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information., These events may happen the first time you take the sleep aid, or after you’ve been taking it for a while. Complex sleep behaviors can be very dangerous and may lead to death or serious injuries. Contact your doctor immediately if you experience a complex sleep behavior.
- Interactions with Other Medications: Extreme care should be taken when mixing sleeping pills with alcohol, opiates, antidepressants, or antihistamines. In particular, combining two or more drugs that depress the central nervous system can lead to slowed breathing and even death. The FDA advises doctors to only prescribe these combinations where there is no other alternative.
Overdosing on certain sleep aids can lead to delirium, impaired breathing and circulation, and death. Sleep aids may have additional risks for those with other medical or mental disorders, people who are taking other medications at the same time, and people with health conditions such as kidney disease, liver problems, low blood pressure, breathing difficulties, arrhythmia, or seizures.
Women and older adults tend to metabolize medicine slower, so they usually require lower doses. As there is limited research on the effects of sleep aids while pregnant or breastfeeding, it is generally recommended for pregnant women to avoid taking these medications. Some evidence suggests they may carry risk of harm to a developing fetus.
Older adults are more vulnerable to side effects and injuries from falls National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.
- So care should be taken to prevent alertness and balance problems when taking sleep medications.
- Some sleep aids may also contribute to dementia National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.
Very few studies have been conducted on the use of sleep medication for children, and most experts advise against using sleep aids in this age group. Among the different families of sleep medications National Library of Medicine, Biotech Information The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.
- Benzodiazepines: Though still widely used, benzodiazepines are considered among the more addictive sleep aids. They are not usually prescribed long-term, because most people quickly develop a tolerance to their effects.
- Non-Benzodiazepine “Z Drugs”: Newer Z drugs perform similarly to benzodiazepines, but they have a more favorable side effect profile and less risk of abuse. That said, the FDA recently released a warning U.S. Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. after discovering that Z drugs are more likely to cause complex sleep behaviors.
- Orexin Receptor Antagonists: It appears that the risk for dependence with orexin receptor antagonists is lower than with other drugs. So far, the primary side effect of this newer sleep aid is somnolence.
- Antidepressants: Antidepressants used for sleep may cause headaches and daytime sleepiness. However, the antidepressants most commonly used for insomnia are usually prescribed at lower doses that are less likely to cause side effects. While some people with insomnia do also suffer from bipolar disorder, antidepressants may make insomnia worse.
- Barbiturates : Formerly very popular, barbiturates have now proved to be habit-forming with a high risk of overdose. The FDA recommends against using these except in very specific cases.
- Over-the-Counter Sleep Aids: The active ingredient in sleeping pills is usually an antihistamine. Most people quickly develop a tolerance to antihistamines, and research suggests that antihistamines may lead to poor sleep quality and next-day sleepiness.
- Melatonin: Melatonin is considered one of the safest over-the-counter sleep aids, with few side effects. A prescription drug called ramelteon is designed to mimic the effects of melatonin. Like melatonin, it is not considered habit-forming and it does not affect balance.
Many people assume OTC sleep aids are the safest sleep medications because they are available without a prescription. However, OTC sleep aids may still have serious side effects. Moreover, medications and herbal supplements that are not approved for insomnia by the FDA U.S.
Food and Drug Administration (FDA) The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
may carry additional risks. It is strongly advised to consult a doctor before using OTC medications or Medical Disclaimer: The content on this page should not be taken as medical advice or used as a recommendation for any specific treatment or medication.
- Sateia, M.J., Buysse, D.J., Krystal, A.D., Neubauer, D.N., & Heald, J.L. (2017). Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 13(2), 307–349.
- Moore, T.J., & Mattison, D.R. (2018). Assessment of Patterns of Potentially Unsafe Use of Zolpidem. JAMA internal medicine, 178(9), 1275–1277.
- Qaseem, A., Kansagara, D., Forciea, M.A., Cooke, M., Denberg, T.D., & Clinical Guidelines Committee of the American College of Physicians (2016). Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Annals of internal medicine, 165(2), 125–133.
- Okajima, I., Nakamura, M., Nishida, S., Usui, A., Hayashida, K., Kanno, M., Nakajima, S., & Inoue, Y. (2013). Cognitive behavioural therapy with behavioural analysis for pharmacological treatment-resistant chronic insomnia. Psychiatry research, 210(2), 515–521.
- Sivertsen, B., Madsen, I.E., Salo, P., Tell, G.S., & Øverland, S. (2015). Use of Sleep Medications and Mortality: The Hordaland Health Study. Drugs – real world outcomes, 2(2), 123–128.
- Pagel, J.F., & Parnes, B.L. (2001). Medications for the treatment of sleep disorders: an overview. Primary Care Companion to the Journal of Clinical Psychiatry, 3(3), 118–125.
- Schwab, R.J. (2020, June). Merck Manual Consumer Version: Insomnia and Excessive Daytime Sleepiness (EDS)., Retrieved December 6, 2020, from
- Hansen, R.N., Boudreau, D.M., Ebel, B.E., Grossman, D.C., & Sullivan, S.D. (2015). Sedative Hypnotic Medication Use and the Risk of Motor Vehicle Crash. American journal of public health, 105(8), e64–e69.
- Donnelly, K., Bracchi, R., Hewitt, J., Routledge, P.A., & Carter, B. (2017). Benzodiazepines, Z-drugs and the risk of hip fracture: A systematic review and meta-analysis. PloS one, 12(4), e0174730.
- Schroeck, J.L., Ford, J., Conway, E.L., Kurtzhalts, K.E., Gee, M.E., Vollmer, K.A., & Mergenhagen, K.A. (2016). Review of Safety and Efficacy of Sleep Medicines in Older Adults. Clinical therapeutics, 38(11), 2340–2372.
- Lie, J.D., Tu, K.N., Shen, D.D., & Wong, B.M. (2015). Pharmacological treatment of insomnia. P & T: A Peer-Reviewed Journal for Formulary Management, 40(11), 759–771.
- Center for Drug Evaluation and Research. (2019, May 14). FDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines.U.S. Food and Drug Administration., Retrieved December 6, 2020, from
- Center for Drug Evaluation and Research. (2019, April 30). Sleep Disorder (Sedative-Hypnotic) Drug Information.U.S. Food and Drug Administration., Retrieved December 6, 2020, from
: How to Use Sleep Medications Safely