Decreases sleep latency with repeated use for periods up to 30 days in duration.
Most useful for sleep initiation disorders; does not substantially increase total sleep time or decrease the number of awakenings.
Dosage and Administration
Administration
Oral Administration
Administer orally, generally without regard to meals.
Avoid administration with a high-fat or heavy meal; may decrease rate of absorption and effect on sleep latency.
Administer immediately before retiring (when ready to sleep) or after retiring when experiencing difficulty falling asleep.
Use only when able to get ≥4 hours of sleep; amnesic episodes may result with less (e.g., overnight flight of <4 hours’ duration) sleep.
Dosage
Adults
Insomnia
Oral
Individualize dosage.
Adults <65 years of age: 10 mg. Although risk of certain adverse effects appears to be dose dependent, 20-mg doses have been adequately tolerated; may consider if unresponsive to a trial of lower dosage.
Generally, limit use to 7–10 days; reevaluate patient if plan to use >2–3 weeks.
Prescribing Limits
Adults
Insomnia
Doses >20 mg not adequately studied; not recommended by manufacturer.
Special Populations
Hepatic Impairment
In patients with mild to moderate hepatic impairment, 5 mg; doses >10 mg not recommended. Not recommended in patients with severe hepatic impairment.
Renal Impairment
No dosage adjustment necessary in patients with mild to moderate renal impairment. Not adequately studied in patients with severe renal impairment.
Geriatric Patients
In adults ≥65 years of age, 5 mg may be sufficient; doses >10 mg not recommended.
Debilitated or Low-weight Patients
In debilitated patients or low-weight patients <65 years of age, 5 mg may be sufficient; doses >10 mg not recommended.
Patients Receiving Cimetidine
In patients receiving cimetidine concomitantly, initial dose of 5 mg recommended. (See Specific Drugs under Interactions.)
Cautions
Contraindications
Hypersensitivity to zaleplon or any ingredient in the formulation.
Warnings/Precautions
Warnings
Adequate Patient Evaluation
Insomnia may be a manifestation of an underlying physical and/or psychiatric disorder; carefully evaluate patient before providing symptomatic treatment.
Failure of insomnia to remit after 7–10 days of treatment, worsening of insomnia, or emergence of new abnormal thinking or behavior may indicate the presence of an underlying psychiatric and/or medical condition.
Adverse Psychiatric Events
Abnormal thinking and behavioral changes (e.g. aggressiveness, uncharacteristic extroversion, bizarre behavior, agitation, hallucinations, depersonalization, amnesia) may occur unpredictably. Immediately evaluate any new behavioral sign or symptom.
Complex Sleep-related Behaviors
Potential risk of complex sleep-related behaviors such as sleep-driving (i.e., driving while not fully awake after ingesting a sedative-hypnotic drug, with no memory of the event), making phone calls, or preparing and eating food, while asleep.
Withdrawal Effects
Rapid dosage reduction or abrupt discontinuance of sedatives or hypnotics has resulted in signs or symptoms of withdrawal.
Rebound insomnia (1 day in duration) observed, principally in patients receiving 20-mg dose. At least 2 cases of seizure (1 with seizure history) reported.
Abuse Potential
Abuse potential of high doses (2.5–7.5 times recommended hypnotic dose) similar to that of benzodiazepines and related hypnotics.
Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.
CNS Effects
Rapid onset of CNS effects (short-term memory impairment, hallucinations, impaired coordination, dizziness, lightheadedness); administer only immediately before going to bed or after unsuccessfully attempting to sleep.
Peformance of activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle) may be impaired the day after ingestion.
Concurrent use of other CNS depressants may cause additive or potentiated CNS depression. (See Specific Drugs under Interactions.)
Sensitivity Reactions
Potential risk of anaphylaxis and angioedema; may occur as early as the first dose of the drug.
Tartrazine
Preparations contain tartrazine (FD&C; yellow No. 5). Tartrazine may cause allergic reactions including bronchial asthma in susceptible individuals. Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin.
General Precautions
Respiratory Effects
Possible depressed respiration with sedative-hypnotics. No respiratory depressant effects reported at hypnotic doses of zaleplon in healthy individuals or in patients with mild to moderate COPD or moderate obstructive sleep apnea.
Caution is advised in patients with impaired respiratory function.
Concomitant Disease
Limited experience in patients with concomitant systemic disease. Use with caution in patients with diseases affecting metabolism or hemodynamic response.
Suicide
Use with caution in depressed patients. Potential for suicidal tendencies; overdosage more frequent in such patients. Prescribe and dispense drug in the smallest feasible quantity. Do not prescribe more than 30-day supply.
Specific Populations
Pregnancy
Category C.
Lactation
Distributed into milk. Use not recommended.
Pediatric Use
Safety and efficacy not established in children <18 years of age.
Geriatric Use
Possibility exists of greater sensitivity to pharmacologic and adverse effects of sedatives and hypnotics in patients ≥65 years of age; reduce initial and maximum dose. (See Geriatric Patients under Dosage and Administration.)
Hepatic Impairment
Reduce dosage for mild to moderate hepatic impairment. Use not recommended in patients with severe hepatic impairment. (See Hepatic Impairment under Dosage and Administration.)
Debilitated Patients
Potential increased sensitivity to sedatives and hypnotics or impaired motor performance after repeated exposure. Reduce dosage and monitor closely. (See Debilitated or Low-weight Patients under Dosage and Administration.)
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