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IMOVANE (ZOPICLONE): WARNINGS

General

Benzodiazepine and benzodiazepine-like compounds should be used with extreme caution in patients with a history of substance or alcohol abuse.

Because some of the adverse effects of Imovane (Zopiclone) may be dose related, the smallest possible effective dose should be prescribed, especially for elderly patients. Inappropriate, heavy sedation in the elderly, may result in accidental events/falls. The use of the lowest effective dose is also consistent with management of other dose-related risks associated with zopiclone.

The cause of insomnia should be identified wherever possible and the underlying factors treated before a hypnotic is prescribed. The failure of insomnia to remit after 7-10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness or the presence of sleep state misperception.

Worsening of insomnia or the emergence of new abnormalities of thinking or behaviour 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.

Imovane (Zopiclone) tablets should be used with caution in patients who in the past manifested paradoxical reactions to alcohol and/or sedative medications.

Lactose is a non-medicinal ingredient in Imovane 5 mg. Patients with rare hereditary diseases of galactose intolerance (galactosemia or glucose-galactose malabsorption) should not take Zopiclone (Imovane) 5 mg. Imovane 7.5 mg tablets does not contain lactose.

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 Imovane (Zopiclone) during pregnancy is not recommended. If this medication 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 her physician regarding the discontinuation of the drug if she intends to become pregnant or suspects that she is pregnant.

During the last weeks of pregnancy or during labor, ingestion of therapeutic doses of benzodiazepine hypnotic drugs has resulted in neonatal CNS depression due to transplacental distribution. Similar effects can be expected to occur with zopiclone, due to its pharmacological effects. If Zopiclone (Imovane) is used during the last three months of pregnancy or during labour, effects on the neonate, such as hypothermia, hypotonia, and respiratory depression can be expected.

A child born to a mother who took sedative/hypnotics agents chronically during the latter stages of pregnancy may have developed physical dependence and may be at risk for developing withdrawal symptoms in the postnatal period.

Amnesia

Anterograde amnesia of varying severity has been reported following therapeutic doses of benzodiazepines or benzodiazepine-like agents. The event is rare with Imovane (Zopiclone) tablets. Anterograde amnesia may occur, especially when sleep is interrupted or when retiring to bed is delayed after the intake of the tablet. Anterograde amnesia is a dose-related phenomenon and elderly subjects may be at particular risk.

Cases of transient global amnesia and "traveler's amnesia" have also been reported in association with benzodiazepines, the latter in individuals who have taken the drug, often in the middle of the night, to induce sleep while travelling. Transient global amnesia and traveler's amnesia are unpredictable and not necessarily dose-related phenomena.

To reduce the possibility of anterograde amnesia, patients should ensure that they take the tablet strictly when retiring for the night. Patients should be warned not to take Zopiclone (Imovane) 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 behavioural changes

Abnormal thinking and other behavioural changes have been reported to occur in association with the use of benzodiazepines and benzodiazepine-like agents including Zopiclone (Imovane) tablets, although rarely. Some of the changes may be characterized by decreased inhibition, e.g., aggression 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 behaviour 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 restlessness, abnormal behaviour, agitation, hallucinations, irritability, delusion, nightmare, anger and depersonalization. Abnormal behaviours 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 of abnormal behaviours listed above is drug induced, spontaneous in origin, or a result of an underly ing psychiatric disorder. Nevertheless, the emergence of any new behavioural sign or symptom of concern requires careful and immediate evaluation. Should these occur, use of the product should be discontinued. These reactions are more likely to occur in the elderly.

Cognitive Function

The benzodiazepines and benzodiazepine-like agents affect mental efficiency, e.g., attention, concentration 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 Imovane (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 Zopiclone (Imovane) 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.

As with other hypnotics, Imovane (Zopiclone) tablets does not constitute a treatment of depression and may even mask its symptoms.

Complex sleep-related behaviours

Complex sleep-related behaviours such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in patients who have taken Zopiclone (Imovane) tablets. Other potentially dangerous behaviours have been reported in patients who got out of bed after taking a sedative-hypnotic and were not fully awake, including preparing and eating food, making phone calls, leaving the house, etc. As with "sleep-driving", patients usually do not remember these events. Although complex sleep-related behaviours may occur with Ieovane alone at therapeutic doses, the use of alcohol and other CNS-depressants with Zopiclone appears to increase the risk of such behaviours, as does the use of this drug at doses exceeding the maximum recommended dose.

Imovane (Zopiclone) is not to be taken with alcohol.

Caution is needed with concomitant use of other CNS depressants drugs.

Caution is recommended in patients with a personal or family history of sleepwalking. Although complex sleep-related behaviours have been reported in patients with or without history of sleepwalking, it is possible that some predisposed patients are at increased risk of experiencing these complex behaviours during treatment with Zopiclone (Imovane).

The use of Imovane (Zopiclone) tablets in patients with other disorders known to affect sleep and induce frequent awakenings (e.g. sleep apnea, Restless Legs Syndrome, Periodic Limb Movement Disorder) is discouraged, as they may be also at increased risk of complex sleep-related behaviours.

Treatment with Zopiclone (Imovane) tablets is limited to a short duration.

Patients should be instructed not to exceed the recommended dose.

Caution should be exercised with concomitant use of potent CYP3A4 inhibitors.

Due to the risk to the patient and the community, discontinuation of Imovane should be strongly considered for patients who report any such complex sleep-related behaviours.

CNS Depressant Effects and Next-Day Impairment

Like other sedative/hypnotic drugs, Imovane (Zopiclone) has CNS-depressant effects. Due to the rapid onset of action, Zopiclone should be ingested immediately prior to going to bed. 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 after ingesting the drug.

This includes potential impairment of the performance of such activities that may occur the day following ingestion of Zopiclone (Imovane). The risk of next day psychomotor impairment, including impaired driving, is increased if this medicine is taken with less than a full night of sleep remaining; if a higher dose than the recommended dose is taken; if co-administered with other CNS depressants; or if co-administered with other drugs that increase the blood level of zopiclone. Patients should be cautioned against taking Imovane (Zopiclone) tablets in these circumstances.

The lowest effective dose for the patient should be used.

Zopiclone (Imovane) tablets are not to be taken with alcohol or other sedative hypnotics (including other zopiclone products) at bedtime or the middle of the night. If concomitant use of another CNS depressant or a drug that increases zopiclone blood levels is clinically warranted, dosage adjustments of Imovane may be necessary.

Even if this medication is taken as instructed, some patients may still have zopiclone blood levels in the morning high enough to produce impairment.

Patient counseling information regarding next-day impairment: Tell patients that Imovane (Zopiclone) has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients not to drive a car or engage in hazardous activities requiring complete alertness until they experience how the drug affects them the next day. Tell patients that if they took Zopiclone as instructed and do not feel drowsy in the morning, they still have to wait for at least 12 hours after dosing before driving or engaging in other activities requiring full mental alertness, especially for elderly patients and for patients who take the 7.5 mg dose. Inform patients that impairment can be present despite feeling fully awake.

Severe Anaphylactic and Anaphylactoid Reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Zopiclone (Imovane). Some patients have had additional symptoms such as dyspnea, throat closing or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis or larynx, airway obstruction may occur and be fatal.

Patients who develop angioedema after treatment with Imovane (Zopiclone) tablets should not be rechallenged with the drug.

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