A course of treatment should employ the lowest effective dose for the minimum length of time necessary for effective treatment. See Posology and method of administration section for guidance on possible treatment regimen. A course of treatment should not continue for longer than 4 weeks including any tapering off.

Amnesia:

Amnesia is rare, but anterograde amnesia may occur, especially when sleep is interrupted or when retiring to bed is delayed after taking the film coated tablet. Therefore, patients should ensure that they take the film coated 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).

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.

Other psychiatric and paradoxical reactions:

Other psychiatric and paradoxical reactions have been reported (see section 4.8, undesired 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.

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)

Somnambulism and associated behaviours:

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 of zopiclone at doses exceeding the maximum recommended dose. Discontinuation of zopilcone should be strongly considered for patients who report such behaviours (see Section 4.5 Interactions with other medicinal products and other forms of interactions)

Excipients:

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galastose malabsorption should not take this medicine.

4.5 Interaction with other medicinal prod