ZOPICLONE

Posology Use the lowest effective dose. Zopiclone 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.

4). The product should be taken just before retiring for the night. 5 mg zopiclone) by the oral route shortly before retiring. 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 patients 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. 75 mg zopiclone nightly is recommended.

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.

. 75 mg.. 75 mg zopiclone is recommended initially. 5 mg. Method of administration For oral use only. Each tablet should be swallowed without sucking or chewing.

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 reactions Psychiatric disorders Uncommon: nightmare, agitation.

4), dependence, withdrawal syndrome (see below). Nervous system disorders Common: dysgeusia (bitter taste), somnolence (residual) Uncommon: Headache, dizziness Rare: anterograde amnesia Not known: ataxia, paraesthesia, congnitive disorders such as memory impairment, disturbance in attention, speech disorder.

4) Gastrointestinal disorders Common: dry mouth.

Uncommon: nausea and 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 the elderly patients). 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. uk/yellowcard.

The cause of insomnia should be identified wherever possible and the underlying factors treated before a hypnotic is prescribed. 2). 3). 2). 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. 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 Zopiclone 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.

Zopiclone should be used with extreme caution in patients with current or a history of alcohol, substance or drug abuse or dependence. 8). Withdrawal The termination of treatment with Zopiclone is unlikely to be associated with withdrawal effects when duration of treatment is limited to 4 weeks.

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). Zopiclone should be administered with caution in patients exhibiting symptoms of depression.

Suicidal tendencies may be 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. Pre-existing depression may be unmasked during use of Zopiclone.

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 Zopiclone 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. 2).

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. 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 […]

Zopiclone is contra-indicated 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.

− Who have previously experienced complex sleep behaviours after taking Zopiclone. As with all hypnotics Zopiclone should not be used in children.