Risk of dependence:As with the benzodiazepines and other benzodiazepine-like drugs, there is a risk of physical and psychological dependence. This risk increases with dose and length of treatment. Patients with a history of alcohol and/or drug abuse or those with personality disorders are more at risk of dependence and this should be considered when prescribing zopiclone. If a patient does become dependent, abrupt cessation of treatment may result in withdrawal symptoms including: anxiety, headaches, muscle pain, tension, confusion and restlessness and irritability. In severe cases symptoms may also include personality disturbances, derealisation, numbness of the extremities, hypersensitivity to noise, light and physical contact, hallucinations or epileptic seizures.
Rebound insomnia:On cessation of treatment with zopiclone, there may be a transient, and often enhanced, recurrence of insomnia which may be accompanied by some of the withdrawal symptoms described above. Abrupt discontinuation of treatment should be avoided, instead, the dosage should be reduced gradually.Depression:Zopiclone does not constitute a treatment for depression. 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 effects of benzodiazepines and benzodiazepine-like agents may develop after repeated use for a few weeks. However with Zopiclone no marked tolerance occurred during treatment periods of up to four weeks.
Amnesia:If sleep is interrupted or retiring to bed is delayed after taking the tablet, the patient may suffer anterograde amnesia, situations when this might occur should therefore be avoided.
Psychiatric and 'Paradoxical' reactions:It is known that reactions such as restlessness, agitation, irritability, aggression, delusion, outbursts of rage, nightmares, hallucinations, psychoses, unsuitable behaviour and other behavioural disturbances may occur during the use of benzodiazepines and benzodiazepine-like substances. If this is the case administration of the medicinal product should be discontinued.
Somnambulism and associated behaviours:Sleepwalking 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. It appears that there is an increased risk of such behaviour with the concomitant use of alcohol, other CNS depressants or the use of zopiclone at doses exceeding the maximum recommended dose. If such behaviours are reported, administration of zopiclone should be discontinued (see Section 4.5).
Specific patient groups:For the elderly: Hypnotics should be avoided in the elderly who are at risk of becoming ataxic and confused and so liable to fall and injure themselves. If, based on clinical need, a decision to treat is nevertheless taken, treatment should be initiated at a lower dose (see section 4.2) and co-administration of zopiclone with CYP3A4 inhibitors should be avoided (see section 4.5).A lower dose is advised for patients with chronic respiratory insufficiency due to the risk of respiratory depression. Benzodiazepines and benzodiazepine-like substances are not suitable for the treatment of patients with severe hepatic insufficiency, since they may promote the occurrence of encephalopathy. Benzodiazepines and benzodiazepine-like substances are not recommended as the primary treatment of psychoses. Benzodiazepines and benzodiazepine-like substances should not be used as the sole treatment of depression or anxiety linked with depression (suicide may be triggered in such patients). Benzodiazepines and benzodiazepine-like substances should be administered with extreme caution to patients with a previous history of alcohol and drug abuse.Before starting treatment with zopiclone any underlying cause of insomnia should be addressed carefully.
Period of treatment:The period of treatment should be as short as possible (see Posology and method of administration) but not longer than 4 weeks including the tapering off process. This period should only be exceeded after re-evaluation of the patient's condition. It may be of benefit to inform the patient at the beginning of treatment that the treatment will be of short duration, and to explain precisely how to reduce the dose gradually. It is also important to point out to the patient the possibility of the occurrence of rebound phenomena in order to keep to a minimum any worries about the occurrence of such symptoms during the tapering off period of the treatment. In the case of benzodiazepines and benzodiazepine-like substances with a short period of action, there are indications that withdrawal symptoms may occur within the dosage interval, especially if the dose is high.Excipients:Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.