zopiclone

General

Canada-Approved Medicine

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.

Pronunciation:
zoe-pi-clone

Trade Name(s)

  • ImovaneCanadian Tradename

Ther. Class.
sedative/hypnotics

Pharm. Class.
cyclopyrrolones

Indications

Short-term treatment of insomnia characterized by difficulty falling asleep and frequent/early awakenings.

Action

Interacts with GABA-receptor complexes; not a benzodiazepine.

Therapeutic Effect(s):

Improved sleep with decrease latency and increased maintenance of sleep.

Pharmacokinetics

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.

TIME/ACTION PROFILE

ROUTEONSETPEAKDURATION
POrapid2 hr6 hr

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity;
  • 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.

Interactions

Drug-Drug

Route/Dosage

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 Impairment


Renal Impairment
PO: (Adults) 3.75 mg initially taken immediately before bedtime; may be ↑ up to 7.5 mg if needed.

Availability

Tablets: 5 mg, 7.5 mg

Assessment

  • 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.

Potential Diagnoses

  • Insomnia
  • Risk for injury

Implementation

  • 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.

Patient/Family Teaching

  • Instruct patient to take zopiclone as directed. Advise patient not to take zopiclone unless able to stay in bed a full night (7–8 hours) 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.

Evaluation/Desired Outcomes

Relief of insomnia by improved falling asleep and decreased frequency of nocturnal and early morning awakenings.

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