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 decreased 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.
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.
Emergency Central is a collection of disease, drug, and test information including 5-Minute Emergency Medicine Consult, Davis’s Drug, McGraw-Hill Medical’s Diagnosaurus®, Pocket Guide to Diagnostic Tests, and MEDLINE Journals created for emergency medicine professionals. Complete Product Information.