This monograph describes a medication approved for use in Canada by the Therapeutic Products Directorate, a division of Health Canada’s Health Products and Food Branch. The medication is not approved by the United States Food and Drug Administration; however, a similar formulation carrying a different generic or brand name might be available in the US.
Short-term treatment of insomnia characterized by difficulty falling asleep and frequent/early awakenings.
Interacts with GABA-receptor complexes; not a benzodiazepine.
Improved sleep with decrease latency and increased maintenance of sleep.
Absorption: Rapidly absorbed (75%) following oral administration.
Distribution: Rapidly distributed from extravascular compartment. Enters breast milk in concentrations that are 50% of plasma levels.
Metabolism and Excretion: Extensively metabolized (mostly by the CYP3A4 enzyme system), metabolites have minimal sedative/hypnotic activity; 4–5% excreted unchanged in urine.
Half-life: 5 hr.
|PO||rapid||2 hr||6 hr|
- Myasthenia gravis;
- Severe hepatic impairment;
- Severe respiratory impairment (including sleep apnea);
- Galactose intolerance (5 mg tablet contains lactose);
- OB: May cause fetal harm, neonatal CNS depression or withdrawal;
- Lactation: Breast feeding not recommended.
Use Cautiously in:
- Renal, hepatic or pulmonary impairment (dosage ↓ may be recommended);
- Past history of paradoxical reactions to sedative/hypnotics or alcohol or violent behavior;
- History of depression or suicidal ideation;
- Geri: ↑ sensitivity may ↑ the risk of falls, confusion or anterograde amnesia (use lowest effective dose);
- Pedi: Safety and effectiveness not established.
Exercise Extreme Caution in:
History of substance/alcohol abuse.
Adverse Reactions/Side Effects
CV: abnormal thinking, behavioral changes, sleep-driving
GI: bitter taste, anorexia, constipation, dry mouth, dyspepsia
Misc: allergic reactions including anaphylaxis, anaphylactoid reactions and angioedema
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
- ↑ risk of CNS depression with other CNS depressants including antihistamines, antidepressants, opioids, sedative/hypnotics, and antipsychotics.
- ↑ levels and risk of CNS depression with drugs that inhibit the CYP3A4 enzyme system, including erythromycin ketoconazole, itraconazole, clarithromycin, nefazodone, ritonavir, and nelfinavir ; ↓ dose may be necessary.
- Levels and effectiveness may be ↓ by drugs that induce the CYP3A4 enzyme system, including carbamazepine, phenobarbital, phenytoin, rifampicin, and rifampin ; dose ↑ may be necessary.
PO (Adults): 5–7.5 mg taken immediately before bedtime; not to exceed 7.5 mg or 7–10 days use. Geri: 3.75 mg initially taken immediately before bedtime; may be ↑ up to 7.5 mg if needed.
Hepatic Renal Impairment
PO (Adults): 3.75 mg initially taken immediately before bedtime; may be ↑ up to 7.5 mg if needed.
Tablets: 5 mg, 7.5 mg
- Assess mental status, sleep patterns, and previous use of sedative/hypnotics. Prolonged use of >7–10 days may lead to physical and psychological dependence.
- Assess alertness at time of peak of drug. Notify health care professional if desired sedation does not occur.
- Assess patient for pain. Medicate as needed. Untreated pain decreases sedative effects.
- Risk for injury
Before administering, reduce external stimuli and provide comfort measures to increase effectiveness of medication.
- Protect patient from injury. Raise bed side rails. Assist with ambulation. Remove patient's cigarettes.
- Use lowest effective dose.
- PO Tablets should be swallowed with full glass of water. For faster onset of sleep, do not administer with or immediately after a meal.
- Instruct patient to take zopiclone as directed. Advise patient not to take zopiclone unless able to stay in bed a full night (7–8 hr) before being active again. Do not take more than the amount prescribed because of the habit-forming potential. Not recommended for use longer than 7–10 days. If used for 2 wk or longer, abrupt withdrawal may result in fatigue, nausea, flushing, light-headedness, uncontrolled crying, vomiting, GI upset, panic attack, or nervousness. Instruct patient to read Patient Information for correct product before taking and with each Rx refill, changes may occur.
- Because of rapid onset, advise patient to go to bed immediately after taking zopiclone.
- May cause daytime drowsiness or dizziness. Advise patient to avoid driving or other activities requiring alertness until response to this medication is known.
- Caution patient that complex sleep-related behaviors (sleep-driving) may occur while asleep.
- Advise patient to notify health care professional immediately if signs of anaphylaxis (swelling of the tongue or throat, trouble breathing, and nausea and vomiting) occur.
- Caution patient to avoid concurrent use of alcohol or other CNS depressants.
Relief of insomnia by improved falling asleep and decreased frequency of nocturnal and early morning awakenings.
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