How Long Does Zopiclone 3.75 Take To Work

Dosage and strength – Zopiclone tablets come in 2 different strengths: 3.75mg and 7.5mg. The usual dose is one 7.5mg tablet, taken just before you go to bed. It takes around 1 hour to work. A lower dose of 3.75mg may be recommended to begin with if you’re over 65 years old or have kidney or liver problems.

How long does zopiclone 3.75 mg keep you asleep?

The side effects of taking zopiclone – The most frequently reported side effect of zopiclone, reported in about 10% of people, is a bitter or metallic taste.5 Other frequently reported side effects of zopiclone include:

nausea dizziness asthenia (abnormal physical weakness or lack of energy) increased sweating headaches sedation, somnolence and tiredness.

A study in healthy volunteers found no residual effects of the drug on psychomotor performance (i.e. activities such as throwing a ball, using a tool or driving a car) the day after a 7.5mg dose.3 However, there are other reports that do show impairment as a measure of coordination and performance of skilled tasks. Hypnotics are often prescribed to the elderly. There is however a concern that they may impair both balance and memory functions. More adverse effects on how the drugs such as zopiclone tend to have more adverse effects in older people. These include cognitive processes such as being able to concentrate or remember things.

Increased daytime fatigue is also reported more frequently in older people being treated for insomnia. These drugs also tend to affect psychomotor functions more in the elderly too. This refers to carrying out everyday tasks which involve coordinated movement, such as driving a car, playing an instrument, sewing or throwing a ball.

A study compared the effect of three hypnotics — including zopiclone 3.75mg and placebo — in 49 healthy volunteers aged 65 years and above.6 All active drugs were found to have a negative effect on balance and also reaction time on a test of memory. The effects of zopiclone were found to persist for 8-9 hours, suggesting a possibility of a reduction in function after waking the morning after a night-time dose.

How quickly do you fall asleep with zopiclone?

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

What does 3.75 mg of zopiclone do?

How does this medication work? What will it do for me? – Zopiclone belongs to the class of medications called sedative-hypnotics. It is used for the short-term and symptomatic relief of sleep disturbances. Zopiclone can help with difficulty falling asleep, frequent wake-ups during the night, or early morning awakenings.

Zopiclone should usually not be taken for more than 7 to 10 consecutive days. It should be used only by people for whom disturbed sleep results in problems functioning during the day. This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here.

As well, some forms of this medication may not be used for all of the conditions discussed here. Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor.

How often can I take zopiclone 3.75 mg?

How should I take zopiclone? –

Always take this medication exactly as your doctor or pharmacist tells you to. You should check with them if you are not sure. Treatment with this medication should be as short as possible, because the risk of dependence increases with the duration of treatment. Swallow your tablet with a drink of water. Do not crush or chew your tablet. Take your prescribed dose just before bedtime and do not take again during the same night. Only take this medication if you are able to get a full 7 to 8 hours sleep before you need to be active again. The usual length of treatment is 2 days to 3 weeks. Keep taking zopiclone until your doctor tells you to stop. Do not stop taking this medication suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time. If you stop taking zopiclone suddenly, your sleep problems may come back and you may get a ‘withdrawal effect’. If this happens you may get some of the effects listed below. See a doctor straight away if you get any of the following effects:

Feeling anxious, shaky, irritable, agitated, confused or having panic attacks Sweating Headache Faster heartbeat or uneven heartbeat (palpitations) A lower level of awareness and problems with focusing or concentrating Nightmares, seeing or hearing things that are not real (hallucinations) Being more sensitive to light, noise and touch than normal Relaxed grip on reality Numbness and tingling in your hands and feet Aching muscles Stomach problems In rare cases fits (seizures) may also occur.

Is 3.75 zopiclone strong?

Dosage and strength – Zopiclone tablets come in 2 different strengths: 3.75mg and 7.5mg. The usual dose is one 7.5mg tablet, taken just before you go to bed. It takes around 1 hour to work. A lower dose of 3.75mg may be recommended to begin with if you’re over 65 years old or have kidney or liver problems.

Does zopiclone promote deep sleep?

Avoid alcohol – Do not drink alcohol while taking zopiclone. It can make you sleep very deeply. You might not breathe properly and can have difficulty waking up.

Can I take half of 3.75 zopiclone?

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

What sleeping pill is better than zopiclone?

CONCLUSIONS – Chronic insomnia and pain are common interrelated comorbidities. There is a higher prevalence of chronic pain and insomnia in nonelderly adults compared to elderly patients. Regular opioid analgesic use is a risk factor for insomnia, but multimodal nonopioid analgesia may minimize insomnia.

Clonidine reliably provides and augments analgesia. Clonidine is significantly better than zopiclone with respect to analgesia, tolerability profile, and patient safety. Clonidine is significantly better than zopiclone in terms of overall sleep quality, total Likert sleep score, time to fall asleep, feeling rested on waking in the morning, and total sleep duration.

Further and larger clinical studies comparing clonidine with other insomnia medications would be beneficial.

Will zopiclone help with anxiety?

Zopiclone reduces day time anxiety; has low frequency of rebound insomnia – Indicators of the propensity for dependence with a hypno-sedative such as zopiclone are day time anxiety and rebound insomnia. A study 3 comparing 4 weeks’ treatment with zopiclone 7.5mg, triazolam 0.5mg and placebo in patients with generalised anxiety disorder found significantly (p 4 zopiclone was associated with a lower frequency and lesser intensity of rebound insomnia following abrupt discontinuation than triazolam.

What can you not take with zopiclone?

Strong painkillers such as codeine, methadone, morphine, oxycodone, pethidine or tramadol. erythromycin or clarithromycin, antibiotics used to treat infections. medicines used to treat fungal infections, such as ketoconazole or itraconazole. ritonavir, a medicine used to treat HIV infections.

Can you have 15mg of zopiclone?

Abstract – Sixty insomniac patients participated in a controlled double-blind parallel group study designed to investigate the dose-response relationship of zopiclone. Following 1 day of treatment with placebo, patients were randomly assigned to 1 of 6 groups and received treatment for 7 days with either placebo, or flurazepam 30 mg, or zopiclone, 3.75 mg, 7.5 mg, 11.25 mg or 15 mg.

Four patients were dropped from the study; two from the placebo group due to ineffectiveness and one each in zopiclone 11.25 mg and 15 mg groups due to side-effects. Flurazepam 30 mg significantly improved sleep induction and maintenance by comparison to placebo and was indistinguishable from zopiclone 7.5 mg or higher.

Results of a self-administered sleep questionnaire found a predominantly linear relationship between the dose of zopiclone administered and the degree of sleep improvement. The greatest increment in improvement was generally obtained with 3.5 mg and 7.5 mg of zopiclone, with some additional benefit occurring with zopiclone 11.25 mg.

What is the elimination time for zopiclone?

Zopiclone should be used at the lowest effective dose and only for short periods – Zopiclone is indicated for the short-term treatment of insomnia in adults 1, The approved adult dose is 7.5 mg taken shortly before bedtime for up to a maximum of 4 weeks.

Medsafe has not assessed the safety and efficacy of longer-term use. Use of zopiclone for longer than 4 weeks should be considered ‘off-label’. If zopiclone is needed to manage insomnia, it should be used in conjunction with non-pharmacological approaches, such as managing expectations about sleep duration, improving sleep hygiene, modifying lifestyle factors, and addressing underlying health issues and psychological stress 2–4,

Long term use of zopiclone may cause tolerance and dependence, leading to withdrawal and rebound insomnia if the medicine is stopped abruptly. A gradual reduction in dose and/or frequency of use can reduce the likelihood of withdrawal effects after long-term use 1–3,

Will zopiclone make me sleepy the next day?

Key Messages –

• Patients taking zopiclone should be warned that their ability to drive or operate dangerous machinery may be impaired the next day.
• Effects on driving performance may be significantly impaired for at least 11 hours after taking the medicine.
• Zopiclone is intended for occasional use in adults at a dose of 7.5 mg orally shortly before bedtime. It should not be used for more than four weeks.
• The initial dose should be reduced in older people.

Zopiclone is used for the treatment of short-term and chronic insomnia in adults. This includes difficulties with falling asleep (initial insomnia) and night time awakening (middle insomnia). Patients taking zopiclone should be warned that their ability to drive or operate dangerous machinery may be impaired the next day.

Importantly the patient may not be aware that they are impaired, especially if they feel they have had a good night’s sleep. A recent article concluded that zopiclone 7.5 mg caused a significant impairment of driving performance for at least 11 hours after administration. These effects did not differ between males and females and did not increase with age,

Concomitant intake of even small amounts of alcohol is also known to increase the risk of zopiclone adversely affecting a patient’s driving ability, In the last 10 years, the Centre of Adverse Reactions Monitoring (CARM) has received 15 reports of psychomotor impairment experienced within 24 hours of taking zopiclone.

1. The reported reactions include impaired concentration, somnolence (sleepiness), headache and hangover.
2. In adults, the usual dose is 7.5 mg shortly before bedtime for a maximum of 2–4 weeks,,
3. Due to poorer metabolism, the dose for older people is reduced to an initial dose of 3.75 mg, ­— taking a full dose will increase the risk of next-day impairment.

To reduce the risk of next-day impairment, this dose should not be exceeded. Prescribers are also reminded that zopiclone should only be used as a short term treatment (should not exceed four weeks).

How long does zopiclone peak?

My Account Area – 1. Name of the medicinal product Zimovane 7.5 mg film-coated tablets 2. Qualitative and quantitative composition Zopiclone 7.5 mg Excipient(s) with known effect: Lactose Wheat starch (containing gluten) (see section 4.4) For the full list of excipients, see section 6.1.3. Pharmaceutical form Film-coated tablet (tablet) White, elliptical, biconvex film-coated tablets with a score-line on one side. The tablet can be divided into equal halves.4. Clinical particulars 4.1 Therapeutic indications Zimovane is indicated for the short-term treatment of insomnia in adults.4.2 Posology and method of administration Posology Use the lowest effective dose. Zimovane should be taken in a single intake and not be re-administered during the same night. As with all hypnotics, long term use of zopiclone is not recommended. Treatment should be as short as possible and should not exceed four weeks including the period of tapering off. Extension beyond the maximum treatment period should not take place without re-evaluation 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. Adults The recommended dose is one Zimovane tablet (7.5 mg zopiclone) by the oral route shortly before retiring. Elderly patients 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. Paediatric population Zopiclone should not be used in 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. Patients with hepatic insufficiency As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower dose of 3.75 mg zopiclone nightly is recommended. The standard dose of 7.5 mg zopiclone may be used with caution in some cases, depending on effectiveness and acceptability. Renal insufficiency Accumulation of zopiclone or its metabolites has not been seen during treatment of insomnia in patients with renal insufficiency. However, it is recommended that patients with impaired renal function should start treatment with 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. Method of administration For oral use only. Each tablet should be swallowed without sucking or chewing.4.3 Contraindications Zimovane is contraindicated in patients: • With myasthenia gravis • With respiratory failure • With severe sleep apnoea syndrome • With severe hepatic insufficiency • With hypersensitivity to zopiclone or to any of the excipients listed in section 6.1 • Who have previously experienced complex sleep behaviours after taking zopiclone (see section 4.4). As with all hypnotics Zimovane should not be used in children.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. Specific patient groups Use in hepatic insufficiency A reduced dosage is recommended (see section 4.2). Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy (see section 4.3). Use in renal insufficiency A reduced dosage is recommended (see section 4.2). 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 in 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). Risk of dependence Use of zopiclone may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence increases with dose and duration of treatment. Cases of dependence have been reported more frequently in patients treated with Zimovane for longer than 4 weeks. The risk of abuse and dependence is also greater in patients with a history of psychiatric disorders and/or alcohol, substance or drug abuse. Zimovane should be used with extreme caution in patients with current or a history of alcohol, substance or drug abuse or dependence. If physical dependence is developed, a sudden discontinuation of treatment will be accompanied by withdrawal symptoms (see section 4.8). Withdrawal The termination of treatment with Zimovane is unlikely to be associated with withdrawal effects when duration of treatment is limited to 4 weeks. Patients may benefit from tapering off the dose before discontinuation (see section 4.8). Suicidal ideation/suicide attempt/suicide depression Some epidemiological studies show an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression, and treated with benzodiazepines and other hypnotics, including zopiclone. However, a causal relationship has not been established. As with other hypnotics, zopiclone does not constitute a treatment for depression and may even mask its symptoms (suicide may be precipitated in such patients). Zimovane should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present therefore the least amount of Zimovane that is feasible should be supplied to these patients to avoid the possibility of intentional overdose by the patient. Pre-existing depression may be unmasked during use of Zimovane. Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists. Any underlying cause of the insomnia should also be addressed before symptomatic treatment to avoid under treating potentially serious effects of depression. 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 Zimovane there is an absence of any marked tolerance during treatment periods of up to 4 weeks. 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 may be 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 section 4.2). A course of treatment should not continue for longer than 4 weeks including any tapering off (see section 4.8). Amnesia Amnesia is rare, but 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 7 – 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 CNS depressants, 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. Risks from concomitant use with opioids Concomitant use of opioids with benzodiazepines or other sedative-hypnotic drugs, including zopiclone may result in sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of opioids and benzodiazepines for use in patients for whom alternative treatment options are inadequate. If a decision is made to prescribe zopiclone concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation (see section 4.5). Other psychiatric and paradoxical reactions Other psychiatric and paradoxical reactions have been reported (see section 4.8), like restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, abnormal behaviour, delirium 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 behaviour, including sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, making phone calls or having sex, with amnesia for the event have been reported in patients who had taken zopiclone and were not fully awake. These events may occur following the first or any subsequent use of zopiclone. Discontinue treatment immediately if a patient experiences a complex sleep behaviour, due to the risk to the patient and others (see section 4.3). 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. Excipients with known effect Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Wheat starch (containing gluten): This medicine contains only very low levels of gluten (from wheat starch) and is very unlikely to cause problems in case of coeliac disease. One 7.5 mg tablet contains no more than 6 micrograms of gluten. Patients with wheat allergy (different from coeliac disease) should not take this medicine.4.5 Interaction with other medicinal products and other forms of interaction Association not recommended: The sedative effect of zopiclone may be enhanced when used in combination with alcohol, concomitant use is therefore not recommended. In particular this could affect the patient’s ability to drive or use machines. Associations to be taken into 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. The effect of erythromycin on the pharmacokinetics of zopiclone has been studied 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. Since zopiclone is metabolised by the cytochrome P450 (CYP) 3A4 isoenzyme (see section 5.2), plasma levels of zopiclone may be increased when co-administered with CYP3A4 inhibitors such as erythromycin, clarithromycin, ketoconazole, itraconazole and ritonavir. A dose reduction for zopiclone may be required when it is co-administered with CYP3A4 inhibitors. Conversely, plasma levels of zopiclone may be decreased when co-administered with CYP3A4 inducers such as rifampicin, carbamazepine, phenobarbital, phenytoin and St. John’s wort. A dose increase for zopiclone may be required when it is co-administered with CYP3A4 inducers. Opioids: The concomitant use of benzodiazepines and other sedative-hypnotic drugs, including zopiclone, and opioids increases the risk of sedation, respiratory depression, coma, and death because of additive CNS depressant effect. Limit dosage and duration of concomitant use of benzodiazepines and opioids (see section 4.4).4.6 Fertility, pregnancy and lactation Pregnancy The use of zopiclone is not recommended 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. Administration of benzodiazepines or benzodiazepine-like substances, including zopiclone, during the late phase of pregnancy or during labour have been associated with effects on the neonate, such as hypothermia, hypotonia, feeding difficulties (‘floppy infant syndrome’), and respiratory depression, due to the pharmacological action of the product. Cases of severe neonatal respiratory depression have been reported. Moreover, infants born to mothers who took sedative/hypnotics agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at risk of developing withdrawal symptoms in the postnatal period. Appropriate monitoring of the newborn in the postnatal period is recommended. If zopiclone is prescribed to a woman of childbearing potential, she should be warned to contact her physician about stopping the product if she intends to become 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.4.7 Effects on ability to drive and use machines Because of its pharmacological properties and its effect on central nervous system, Zimovane 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: 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); very rare (< 1/10,000); not known (cannot be estimated from the available data). Immune system disorders Very rare: angioedema, anaphylactic reaction Psychiatric disorders Uncommon: nightmare, agitation Rare: confusional state, libido disorder, irritability, aggression, hallucination Not known: restlessness, delirium, delusion, anger, abnormal behaviour (possibly associated with amnesia) and complex sleep behaviours including somnambulism (see section 4.4), dependence, withdrawal syndrome (see below) Nervous system disorders Common: dysgeusia (bitter taste), somnolence (residual) Uncommon: dizziness, headache Rare: anterograde amnesia Not known: ataxia, paraesthesia, cognitive disorders such as memory impairment, disturbance in attention, speech disorder Eye disorders Not known: diplopia Respiratory, thoracic and mediastinal disorders Rare: dyspnoea (see section 4.4) Not known: respiratory depression (see section 4.4) Gastrointestinal disorders Common: dry mouth Uncommon: nausea, vomiting Not known: dyspepsia Hepatobiliary disorders 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 Uncommon : fatigue Not known: light headedness, incoordination Injury, poisoning and procedural complications Rare: fall (predominantly in elderly patients) Withdrawal syndrome has been reported upon discontinuation of zopiclone (see section 4.4). 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 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 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. 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: Hypnotics and sedatives; Benzodiazepine related drugs, ATC Code: N05C F01 Mechanism of action Zopiclone is a hypnotic agent, and a member of the cyclopyrrolone group of compounds. 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. Its pharmacological properties include hypnotic, sedative, anxiolytic, anticonvulsant and muscle-relaxant actions. These are related to its high affinity and specific agonist action at central receptors belonging to the 'GABA' macromolecular receptor complex modulating the opening of the chloride ion channel. 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.5.2 Pharmacokinetic properties Absorption Zopiclone is absorbed rapidly. Peak concentrations are reached within 1.5 – 2 hours and they are approximately 30 ng/ml and 60 ng/ml after administration of 3.75 mg and 7.5 mg respectively. Absorption is not modified by gender, food or repetition of doses. Distribution The product is rapidly distributed from the vascular compartment. Plasma protein binding is weak (approximately 45%) and non-saturable. There is very little risk of drug interactions due to protein binding. The volume of distribution is 91.8 – 104.6 L. At doses between 3.75 – 15 mg, plasma clearance does not depend on dose. The elimination half-life is approximately 5 hours. After repeated administration, there is no accumulation, and inter-individual variations appear to be very small. Metabolism Zopiclone is extensively metabolised in humans to two major metabolites, N-oxide zopiclone (pharmacologically active in animals) and N- desmethyl zopiclone (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-lives (evaluated from the urinary data) are approximately 4.5 hours and 1.5 hours respectively. No significant accumulation is seen on repeated dosing (15 mg) for 14 days. In animals, no enzyme induction has been observed even at high doses. Excretion The low renal clearance value of unchanged zopiclone (mean 8.4 ml/min) compared with the plasma clearance (232 ml/min) indicates that zopiclone clearance is mainly metabolic. The product is eliminated by the urinary route (approximately 80%) in the form of free metabolites (n-oxide and n-desmethyl derivatives) and in the faeces (approximately 16%). Special patient groups In elderly patients, notwithstanding a slight decrease in hepatic metabolism and lengthening of elimination half-life to approximately 7 hours, various studies have shown no plasma accumulation of drug substance on repeated dosing. In renal insufficiency, no accumulation of zopiclone or of its metabolites has been detected after prolonged administration. Zopiclone crosses dialysis membranes. In cirrhotic patients, the plasma clearance of zopiclone is clearly reduced by the slowing of the desmethylation process, dosage will therefore have to be modified in these patients.5.3 Preclinical safety data There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.6. Pharmaceutical particulars 6.1 List of excipients Tablet Core: Lactose monohydrate Calcium hydrogen phosphate dihydrate Wheat starch Sodium starch glycollate Magnesium stearate Film-coating: Hypromellose Titanium dioxide Macrogol 6000 Purified water Or Opadry OY-S-38906 Purified water 6.2 Incompatibilities Not applicable.6.3 Shelf life 24 months 6.4 Special precautions for storage Store below 30°C. Keep the blister in the outer carton in order to protect from light and moisture.6.5 Nature and contents of container PVC/aluminium foil blisters containing 56, 28, 14, 7 or 3 film-coated tablets, and in a starter pack containing 3 film-coated tablets. Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling No special requirements.7. Marketing authorisation holder Aventis Pharma Limited 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Trading as: Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK 8. Marketing authorisation number(s) PL 04425/0624 9. Date of first authorisation/renewal of the authorisation Date of first authorisation: 06 May 1993 Date of latest renewal: 18 March 2005 10. Date of revision of the text 06/07/2023 LEGAL CLASSIFICATION POM

How long do sleeping pills make you sleep?

How effective are sleeping pills? – Studies show that sleeping pills aren’t that helpful in promoting a good night’s rest. Most people who take sleep aids fall asleep about eight to 20 minutes faster than those without medicine. On average, you might get an additional 35 minutes of shuteye.

Can I take half of 3.75 zopiclone?

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