Tablets: 5 mg, 7.5 mg.
Short-term treatment of insomnia characterized by difficulty falling asleep and frequent/early awakenings.
Drug-Drug ↑ risk of CNS depression with other CNS depressants including antihistamines, antidepressants, opioids, sedative/hypnotics and antipsychotics. Levels and effectiveness may be ↓ by drugs that induce the CYP3A4 enzyme system, including carbamazepine, phenobarbital, phenytoin rifampicin and rifampin ; dose increase may be necessary. ↑ 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.
Interacts with GABA-receptor complexes; not a benzodiazepine.
sedative/hypnotics Pharm. Class. cyclopyrrolones. Class. Trade Name(s) Imovane Ther.
PO: (Adults) 5–7.5 mg taken immediay before bedtime; not to exceed 7.5 mg or 7–10 days use. Hepatic Impairment Renal Impairment PO: (Adults) 3.75 mg initially taken immediay before bedtime; may be increased up to 7.5 mg if needed. Geri: 3.75 mg initially taken immediay before bedtime; may be increased up to 7.5 mg if needed.
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.
Therapeutic Effect(s): Improved sleep with decrease latency and increased maintenance of sleep.
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. 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. Pronunciation: zoe- –pi-clone.
Contraindicated in: Hypersensitivity; Myasthenia gravis; Severe hepatic impairment; Severe respiratory impairment (including sleep apnea); OB: May cause fetal harm, neonatal CNS depression or withdrawal; Lactation: Breastfeeding is not recommended; Galactose intolerance (5 mg tablet contains lactose).
Distribution: Rapidly distributed from extravascular compartment Enters breast milk in concentrations that are 50% of plasma levels.
Misc: allergic reactions including anaphylaxis, anaphylactoid reactions and angioedema.
CV: abnormal thinking,, behavioral changes, sleep-driving.
GI: bitter taste, anorexia, constipation, dry mouth, dyspepsia.
Exercise Extreme Caution in: History of substance/alcohol abuse.
Relief of insomnia by improved falling asleep and decreased frequency of nocturnal and early morning awakenings.
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Absorption: Rapidly absorbed (75%) following oral administration.
TIME/ACTION PROFILE ROUTE ONSET PEAK DURATION PO rapid 2 hr 6 hr.
Use Cautiously in: Renal, hepatic or pulmonary impairment (dosage reduction may be recommended); Past history of paradoxical reactions to sedative/hypnotics or alcohol or violent behavior; History of depression or suicidal ideation; Geri: Increased sensitivity may increase the risk of falls, confusion or anterograde amnesia (use lowest effective dose); Pedi: Safe and effective use in children <18 yr has not been established.
Italics indicate most frequent. * CAPITALS indicate life-threatening.