Use in renal insufficiency:

A reduced dosage is recommended; see Posology and method of administration.

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 risk of respiratory depression.

Paediatric population:

Zopiclone should not be used in children and adolescents less than 18 years of age. The safe and effective dose of Zopiclone has not been established in children and young adults less than 18 years.

Use in Elderly:

Elderly should be given a reduced dose (see section 4.2).

Risk of dependence:

Clinical experience to date with Zopiclone 7.5mg tablets 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 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, or those who have marked personality disorders.

The decision to use a hypnotic in such patients should be taken only with this clearly in mind. If physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms (See warnings and precautions). These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion 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 or epileptic seizures.

Rare cases of abuse have been reported.

Withdrawal:

The termination of treatment with Zopiclone 7.5mg, tablets is unlikely to be associated with withdrawal effects when duration of treatment is limited to 4 weeks. Patients may benefit from tapering of the dose before discontinuation (See section 4.8).

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 be also addressed before symptomatic treatment to avoid under treating potentially serious effects of depression. Prescribers are reminded to exclude depression as the underlying source of insomnia.

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 7.5mg tablets there is an absence of any marked tolerance during treatment periods of up to 4 weeks.

Rebound insomnia:

Rebound insomnia is a transient syndrome where the symptoms, which led to the 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 i