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Drug Interactions: Zopiclone may produce additive CNS depressants effect when co-administered with alcohol, sedative antihistamines, anticonvulsants, or psychotropic medications which themselves can produce CNS depression.
Compounds which inhibit certain hepatic enzymes (particularly cytochrome P450) may enhance the activity of benzodiazepines and benzodiazepine-like agents. Examples include cimetidine or erythromycin.
Drug Abuse, Dependence and Withdrawal: Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, dysphoria, perceptual disturbances and insomnia) have occurred following abrupt discontinuation of benzodiazepines and benzodiazepine-like agents including zopiclone. The more severe symptoms are usually associated with higher dosages and longer usage, although patients given therapeutic dosages for as few as 1 - 2 weeks can also have withdrawal symptoms including daytime anxiety between nightly doses. Consequently, abrupt discontinuation should be avoided and a gradual dosage tapering schedule is recommended in any patient taking the drug for more than a few weeks. The recommendation for tapering is particularly important in patients with a history of seizures.
The risk of dependence is increased in patients with a history of alcoholism, drug abuse, or in patients with marked personality disorders. Interdose daytime anxiety and rebound anxiety may increase the risk of dependency in APO-ZOPICLONE treated patients.
As with all hypnotics, repeat prescriptions should be limited to those who are under medical supervision.
Patient with Specific Conditions: APO-ZOPICLONE should be given with caution to patients with impaired hepatic or renal function, or severe pulmonary insufficiency. Respiratory depression has been reported in patients with compromised respiratory function.
Patients Requiring Mental Alertness: Because of zopiclone's CNS depressant effect, patients receiving the drug should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be warned against the concomitant ingestion of APO-ZOPICLONE and alcohol or CNS depressant drugs.
Use in Pregnancy: For teratogenic effects see Warnings. Non teratogenic effects: a child born to mother who is on benzodiazepines or benzodiazepine-like agents may be at risk for withdrawal symptoms from the drug during the postnatal period.
Use in Lactation: Zopiclone is excreted in human milk, and its concentration may reach 50% of the plasma levels. Therefore, the administration of APO-ZOPICLONE to nursing mothers is not recommended.
Use in Children: The safety and effectiveness of zopiclone in children and young adults below the age of 18 have not been established.
Use in the Elderly: Elderly patients are especially susceptible to dose-related adverse effects, such as drowsiness, dizziness, or impaired coordination. Inappropriate heavy sedation may result in accidental event/falls. Therefore, the lowest possible dose should be used in these subjects.
