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Pharmacologic class: Pyrazolopyrimidine, nonbenzodiazepine hypnotic
Therapeutic class: Sedative-hypnotic
Controlled substance schedule IV
Pregnancy risk category C
Binds to omega-1 receptor of gamma-aminobutyric acid receptor complex, relaxing smooth muscles, reducing anxiety, and producing sedation. Also has anticonvulsant effect.
Capsules: 5 mg, 10 mg
Indications and dosages
Adults younger than age 65: 10 mg P.O. at bedtime. Dosage above 20 mg is not recommended.
• Mild to moderate hepatic impairment
• Elderly or debilitated patients
• Hypersensitivity to drug or its components
Use cautiously in:
• tartrazine sensitivity
• severe renal impairment (use not recommended), mild to moderate hepatic impairment, respiratory impairment, depression
• history of suicide attempt
• patients weighing less than 50 kg (110 lb)
• patients older than age 65
• pregnant or breastfeeding patients (use not recommended)
• children younger than age 18 (safety not established).
• Give at bedtime.
• Don't administer with high-fat meal.
CNS: headache, amnesia, anxiety, hallucinations, light-headedness, dizziness, drowsiness, depersonalization, transient memory or psychomotor impairment, incoordination, malaise, vertigo, asthenia, hyperesthesia, paresthesia, tremor
CV: peripheral edema
EENT: abnormal vision, eye pain, ear pain, hearing sensitivity, epistaxis
GI: nausea, abdominal pain, colitis, dyspepsia, anorexia
Other: altered sense of smell, fever
Drug-drug. Cimetidine: decreased metabolism and increased effects of zaleplon
CNS depressants (including antihistamines, opioids, other sedative-hypnotics, phenothiazines, tricyclic antidepressants): additive CNS depression
CYP450-3A4 inducers (such as carbamazepine, phenobarbital, phenytoin, rifampin): decreased blood level and reduced efficacy of zaleplon
CYP450-3A4 inhibitors (such as erythromycin, ketoconazole): increased zaleplon blood level
Drug-food. High-fat meal: delayed drug absorption
Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression
Drug-behaviors. Alcohol use: increased CNS depression
• Monitor drug efficacy. Insomnia persisting after 7 to 10 days warrants reevaluation for underlying psychological or physical illness.
• Stay alert for adverse drug reactions.
• Explain therapy to patient. Emphasize importance of taking drug just before bedtime or after trying to sleep-but only if he will be able to get at least 4 hours of sleep.
• Inform patient that high-fat meal slows drug absorption and delays drug effects.
• Caution patient to avoid driving and other hazardous activities while under drug's influence.
• Instruct patient to avoid alcohol during therapy.
• Tell patient rebound insomnia may occur for 1 or 2 nights after he stops taking drug.
• Advise female of childbearing age to notify prescriber if she is or plans to become pregnant or if she is breastfeeding.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, foods, herbs, and behaviors mentioned above.