See Supplemental Patient Information
- Use cautiously in patients with history of substance or alcohol abuse. Use smallest effective dose in geriatric patients due to risk of heavy sedation resulting in accidental events/falls
- Failure of remission of insomnia following 7- 10 days of therapy may indicate presence of a primary psychiatric and/or medical illness. Re-evaluate the diagnosis in such cases
- Use of zopiclone during last trimester of pregnancy or labor may result in hypothermia, hypotonia, and respiratory depression in fetus and withdrawal symptoms in the newborn
- Anterograde amnesia, transient global amnesia and traveler's amnesia have been reported with use of zopiclone
- Anterograde amnesia is dose-related and more common in elderly. Inform patients to take the dose strictly before bedtime to reduce the occurrence of anterograde amnesia
- Abnormal thinking and behavior changes characterized by decreased inhibition, irritability, hallucinations, anger, nightmares and depersonalization have been reported with use of zopiclone. Discontinue therapy on emergence of any new behavioral symptom and evaluate for presence of any pre-existing psychiatric condition
- Zopiclone may affect mental efficiency, concentration, attention and vigilance, especially in the elderly and patients with cerebral impairment
- Daytime anxiety and/or restlessness have been reported during treatment with zopiclone
- Use cautiously in patients with signs and symptoms of depression due to risk of self-harm or worsening of depression
- Zopiclone is associated with risk of complex sleep-related behaviors such as sleep-driving, making phone calls, or preparing and eating food while asleep. Concomitant use of alcohol and CNS-depressants increases the risk of such behavior
- Rare cases of severe anaphylactic reactions characterized by angioedema of tongue, glottis or larynx, dyspnea, throat closing, nausea and vomiting have been reported with use of zopiclone. If such reactions occur, discontinue therapy and avoid drug rechallenge
- Risk of physical and psychological dependence, and abuse is associated with use of zopiclone, particularly in patients with personality disorders or history of substance/alcohol abuse
- In patients with physical dependence, abrupt discontinuation of therapy may cause withdrawal symptoms characterized by rebound insomnia, mood changes and daytime anxiety. Gradual tapering of dose is recommended prior to discontinuation
Cautions: Use cautiously in
- Mild-moderate hepatic impairment
- Renal impairment
- Chronic respiratory insufficiency
- Hx of substance/alcohol abuse
- Hx of violent behavior
- Hx of unusual reactions to alcohol or sedatives
- Hx/signs of depression
- Cerebral impairment
- Concomitant use of CNS depressant
- Elderly
- Debilitated patients
Supplemental Patient Information
- Instruct patients not to drive or perform any hazardous activities after taking zopiclone until the effects of the medication are fully understood
- Instruct patients not to take zopiclone if a full night’s sleep is not possible before being active and functional again
- Advise patients to avoid taking zopiclone for >7-10 days without consulting their physician
- Advise patients to avoid alcohol intake during therapy
Pregnancy Category:NR
Breastfeeding: Excreted in breast milk, with levels reaching up to 50% of plasma levels. Use in nursing mothers is not recommended due to lack of adequate data regarding safety of zopiclone during lactation.
65 yrs and/or debilitated patients
