Apo-Zopiclone Warnings

General: Benzodiazepines and benzodiazepine-like agents should be used with extreme caution in patients with a history of substance or alcohol abuse.
The smallest possible effective dose should be prescribed for elderly patients. Inappropriate heavy sedation in the elderly may result in accident events/falls.
Worsening of insomnia or the emergence of new abnormalities of thinking or behavior may be the consequence of an unrecognized psychiatric or physical disorder. These have also been reported to occur in association with the use of drugs that act at the benzodiazepine receptors.
Memory Disturbance: Anterograde amnesia of varying severity has been reported following therapeutic doses of benzodiazepines or benzodiazepine-like agents. The event is rare with zopiclone.
Anterograde amnesia is a dose-related phenomenon and elderly subjects may be at particular risk.
Cases of transient global amnesia and "traveller's amnesia" have also been reported in association with benzodiazepine, the later in individuals who have taken the drug, often in the middle of the night, to induce sleep while travelling. Transient global amnesia and traveller's amnesia are unpredictable and not necessarily dose-related phenomena. Patients should be warned not to take APO-ZOPICLONE under circumstances in which a full night's sleep and clearance of the drug from the body are not possible before they need again to resume full activity.
Abnormal Thinking and Psychotic Behavioural Changes: Abnormal thinking and psychotic behavioural changes have been reported to occur in association with the use of benzodiazepines and benzodiazepine-like agents including zopiclone, although rarely. Some of the changes may be characterised by decreased inhibition, e.g. aggressiveness or extroversion that seems excessive, similar to that seen with alcohol and other CNS depressants (e.g. sedative/hypnotics). Particular caution is warranted in patients with a history of violent behavior and a history of unusual reactions to sedatives including alcohol and the benzodiazepines or benzodiazepine-like agents. Psychotic behavioural changes that have been reported include bizarre behavior, hallucinations, and depersonalization. Abnormal behaviour associated with the use of benzodiazepines or benzodiazepine-like agents have been reported more with chronic use and/or high doses but they may occur during the acute, maintenance or withdrawal phases of treatment.
It can rarely be determined with certainty whether a particular instance behaviours listed previously is drug induced, spontaneous in origin, or a result of an underlying psychiatric disorder. Nevertheless, the emergence of any new behavioural sign or symptom of concern requires careful and immediate evaluation.
Confusion: The benzodiazepines and benzodiazepine-like agents affect mental efficiency, e.g. concentration, attention and vigilance. The risk of confusion is greater in the elderly and in patients with cerebral impairment.
Anxiety, Restlessness: An increase in daytime anxiety and/or restlessness have been observed during treatment with zopiclone. This may be a manifestation of interdose withdrawal, due to the short elimination half-life of the drug.
Depression: Caution should be exercised if APO-ZOPICLONE is prescribed to patients with signs and symptoms of depression that could be intensified by hypnotic drugs. The potential for self-harm (e.g. intentional overdose) is high in patients with depression and thus, the least amount of drug that is feasible should be available to them at any one time.
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 zopiclone should be strongly considered for patients who report such behaviours.
Use in Pregnancy: Benzodiazepines may cause fetal damage when administered during pregnancy. During the first trimester of pregnancy, several studies have suggested an increased risk of congenital malformations associated with the use of benzodiazepines.
Insufficient data are available on zopiclone to assess its safety during human pregnancy. Thus the use of APO-ZOPICLONE (zopiclone) during pregnancy is not recommended. If APO-ZOPICLONE is prescribed to a woman of child-bearing potential, the patient should be warned of the potential risk to a fetus and advised to consult the physician regarding the discontinuation of the drug if the patient intends to become pregnant or suspects that the patient is pregnant.
During the last weeks of pregnancy, ingestion of therapeutic doses of a benzodiazepine hypnotic has resulted in neonatal CNS depression due to transplacental distribution. Similar effects can be expected to occur with zopiclone, due to its pharmacological effects.