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  • Imovane
    / Sanofi

    Active Ingredient
    Zopiclone 7.5 mg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    20 X 7.5 mg

    partial basket chart 48590 9115

    Related information


    Treatment should always be initiated at the lowest effective dose and should never exceed the maximum dose. Imovane should be taken in bed before going to sleep. The 3.75 mg dosage strength is specifically suitable for elderly subjects over the age of 65 and special risk populations.
    Adults: The recommended dose is 7.5 mg by the oral route shortly before retiring.
    Elderly : A lower dose of 3.75 mg should be employed to start treatment in the elderly. Depending on effectiveness and acceptability, the dosage subsequently may be increased if clinically necessary.
    Children and young adults less than 18 years : The safe and effective dose has not been established.
    Patients with hepatic insufficiency: As elimination  may be reduced in patients with hepatic dysfunction, a lower dose of 3.75 mg nightly is recommended. The standard dose of 7.5 mg 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. In all cases, the daily dose of this drug should not exceed 7.5 mg.
    For full details see prescribing information.


    Hypnotic when the disorder of insomnia is severe and disabling.


    Hypersensitivity to Zopiclone or any of the excipients. Myasthenia gravis, respiratory failure, severe sleep apnea syndrome, severe hepatic insufficiency As with all hypnotics this drug should not be used in children.           

    Special Precautions

    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.
    Use in renal insufficiency: A reduced dosage is recommended.
    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. A lower dose is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.
    Use in children: The safe and effective dose of Zimovane has not been established in children and young adults less than 18 years. Use in Elderly Elderly should be given a reduced dose.
    Risk of dependence:
    Clinical experience to date suggests that the risk of dependence is minimal when the duration of treatment is limited to not more than 4 weeks. Use of benzodiazepines and benzodiazepine-like agents (even at therapeutic doses) may lead to the development of physical and psychological dependence or abuse upon these products. The risk of dependence or abuse increases with: Dose and duration of treatment. Use with alcohol or other psychotropics. It is also greater in patients with a history of alcohol and or drug abuse. Those patients who have marked personality disorders. The decision to use a hypnotic in such patients should be taken only with this clearly in mind.
    Withdrawal: The termination of treatment 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.
    Depression: 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). Any underlying cause of the insomnia should also be addressed before symptomatic treatment to avoid under treating potentially serious effects of depression. As insomnia may be a symptom of depression, depression must be treated. If insomnia persists, the clinical diagnosis should be re-evaluated. In patients with a major depressive episode: Benzodiazepines and related drugs should not be prescribed alone as they do not treat depression, which will therefore follow its own course, with a persistent or higher risk of suicide. As these patients may be at risk for suicide, the smallest number tablets must be made available to them (prescribed and supplied) in order to minimize the risk of intentional overdose.
    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 Imovane 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.
    Amnesia: Amnesia is rare, but anterograde amnesia may occur, especially when sleep is interrupted or when retiring to bed is delayed after the intake of 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 to 8 hours).
    Driving: It has been reported that the risk that Zopiclone adversely affects driving ability is increased by the concomitant intake of alcohol. Therefore, it is recommended not to drive while taking Zopiclone and alcohol concomitantly.
    Other psychiatric and paradoxical reactions: Other psychiatric and paradoxical reactions have been reported, like restlessness, agitation, irritability, aggression, delusion, anger, nightmares, hallucinations, inappropriate behavior 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.
    Sonambulism and associated behavior:  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. The use of alcohol and other CNS-depressants with Zopiclone appears to increase the risk of such behaviours, as does the use at doses exceeding the maximum recommended dose. Discontinuation should be strongly considered for patients who report such behaviours.
    Risk of drug accumulation: Benzodiazepines and related drugs, (like any medicinal product), remain in the body for a period of approximately 5 elimination half-lives. In elderly patients and those with hepatic insufficiency, the elimination half-life may be considerably longer. Following repeated doses, Zopiclone or its metabolites reach steady state much later and at a much higher level. The efficacy and safety of the drug can only be evaluated once steady state has been reached. Dosage may need to be adjusted. Clinical studies of Zopiclone have not revealed any plasma accumulation in patients with renal insufficiency.
    Duration of treatment: The duration of treatment must be clearly indicated to the patient depending on the type of insomnia.
    Tapering-off process: Patients should be clearly instructed on how to gradually discontinue treatment. In addition to the need to gradually decrease dosage, patients should be warned of the risk of rebound insomnia in order to minimize any insomnia that might result from the withdrawal symptoms caused by treatment discontinuation, even when this is gradual.Patients must be informed of possible discomfort during the tapering-off period.
    Special Precautions for use: Extreme caution is recommended in patients with a history of alcoholism or other addictions, to medicinal products or other substances. In all cases, insomnia should be assessed systematically, and the underlying causes treated, before prescribing a hypnotic agent. Insomnia may be a sign of an underlying physical or psychiatric disorder. The clinical diagnosis should be re-evaluated if the insomnia persists or worsens after a short treatment period.
    For full details see prescribing information.

    Side Effects

    Dysgeusia, somnolence, dry mouth and withdrawal syndrome has been reported upon discontinuation of zopiclone. Withdrawal symptoms vary and may include rebound insomnia, 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.
    For full details see prescribing information.

    Drug interactions

    The sedative effect of Zopiclone may be enhanced when used in combination with alcohol, concomitant use is therefore not recommended. In combination with CNS depressants an enhancement of the central depressive effect may occur. The therapeutic benefit of co-adminstration with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines should therefore be carefully weighed. Concomitant use of benzodiazepines or benzodiazepine-like agents with narcotic analgesics may enhance their euphoric effect and could lead 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.
    Since Zopiclone is metabolized by the cytochrome P450 (CYP) 3A4 isoenzyme, plasma levels may be increased when co adminstered with CYP3A4 inhibitors such as Erythromycin, Clarithromycin, Ketoconazole, Itraconazole and Ritonavir. A dose reduction may be required when it is coadminstered with CYP3A4 inhibitors. Conversely, plasma levels may be decreased when co-administered with CYP3A4 inducers such as Rifampicin, Carbamazepine, Phenobarbital, Phenytoin and St. John’s wort.
    For full details see prescribing information.

    Pregnancy and Lactation

    Insufficient data are available to assess its safety during human pregnancy and lactation.
    Pregnancy: Experience of use during pregnancy in humans is limited although there have been no adverse findings in animals. Use in pregnancy is therefore not recommended.
    Lactation: Zopiclone is excreted in breast milk, although the concentration in the breast milk is low, use in nursing mothers must be avoided.
    For full details see prescribing information.


    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.
    For full details see prescribing information.

    Sanofi Winthrop Industrie, France