Classifications: anxiolytic; sedative-hypnotic; nonbenzodiazepine; Therapeutic: sedative-hypnotic; antianxiety
Pregnancy Category: C
Controlled Substance: Schedule IV
5 mg, 10 mg capsules
Short-acting nonbenzodiazepine with sedative-hypnotic, muscle relaxant, and anticonvulsant activity.
Reduces difficulty in initially falling asleep. Preserves deep sleep (stage 3 through stage 4) at hypnotic dose with minimal-to-absent
rebound insomnia when discontinued.
Short-term treatment of insomnia.
Hypersensitivity to zaleplon, or tartrazine dye (Yellow 5); suicidal ideation; pregnancy (category C); lactation. Safe
use in children not established.
Hypersensitivity to salicylates; concurrent use of other CNS depressants (e.g., benzodiazepines, alcohol); chronic depression;
history of drug abuse; COPD; respiratory insufficiency; hepatic or renal impairment; pulmonary disease.
Route & Dosage
Adult: PO 10 mg h.s. (max: 20 mg h.s.)
Geriatric: PO 5 mg h.s. (max: 10 mg h.s.)
- Give immediately before bedtime; not while patient is still ambulating.
- Give lower dose of 5 mg to older adult or debilitated patients.
- Store at 20°25° C (68°77° F).
Adverse Effects (≥1%) Body as a Whole:
Asthenia, fever, headache,
migraine, myalgia, back pain. CNS:
Amnesia, dizziness, paresthesia
, somnolence, tremor, vertigo, depression
, hypertonia, nervousness, difficulty concentrating. GI:
Abdominal pain, dyspepsia, nausea, constipation
, dry mouth. Respiratory: Bronchitis
Pruritus, rash. Special Senses:
Eye pain, hyperacusis, conjunctivitis
Interactions Drug: Alcohol, imipramine, thioridazine
may cause additive CNS
of zaleplon; cimetidine
levels of zaleplon. Herbal: Valerian, melatonin
may produce additive sedative effects. Food:
High-fat meals may delay absorption.
Rapidly and completely absorbed, 30% reaches systemic circulation. Onset:
1520 min. Peak:
1 h. Duration:
34 h. Distribution:
60% protein bound. Metabolism:
Extensively in liver (CYP3A4) to inactive metabolites. Elimination:
70% in urine, 17% in feces. Half-Life:
Assessment & Drug Effects
- Monitor behavior and notify physician for significant changes. Use extra caution with preexisting clinical depression.
- Provide safe environment and monitor ambulation after drug is ingested.
- Monitor respiratory status with preexisting compromised pulmonary function.
Patient & Family Education
- Exercise caution when walking; avoid all hazardous activities after taking zaleplon.
- Do not take in combination with alcohol or any other sleep medication.
- Note: Exhibits altered effectiveness if taken with/immediately after high-fat meal.
- Do not use longer than 23 wk.
- Expect possible mild/brief rebound insomnia after discontinuing regimen.
- Report use of OTC medications to physician (e.g., cimetidine).
- Report pregnancy to physician immediately.