• Sleep-wake disorders

Sonata Generic Name & Formulations

General Description

Zaleplon 5mg, 10mg; caps; contains tartrazine.

Pharmacological Class

Pyrazolopyrimidine hypnotic.

How Supplied



Generic Availability


Sonata Indications


Short-term treatment of insomnia.

Sonata Dosage and Administration


Use lowest effective dose. Effects delayed if taken with or after a heavy/high-fat meal. Usually 10mg immediately prior to bedtime or after patient has gone to bed and experienced difficulty falling asleep (with at least 7–8hrs of sleep remaining); max 20mg. Mild to moderate hepatic impairment, concomitant cimetidine, or low weight patients: 5mg. Elderly, debilitated: 5mg; max 10mg.


Not established.

Sonata Contraindications


Prior history of complex sleep behaviors with Sonata.

Sonata Boxed Warnings

Boxed Warning

Complex sleep behaviors.

Sonata Warnings/Precautions


Risk of complex sleep behaviors (eg, sleep-walking, sleep-driving, engaging in other activities while not fully awake); discontinue immediately if occur. Monitor for CNS depressant effects and next-day impairment. Evaluate for co-morbid diagnoses (eg, physical and/or psychiatric disorders) prior to treatment. Reevaluate if insomnia fails to remit after 7–10 days of use. Depression. Suicidal tendencies. Evaluate any new onset of behavioral changes. Compromised respiratory function. Conditions that affect metabolism or hemodynamic response. Drug or alcohol abuse. Severe hepatic impairment: not recommended. Avoid abrupt cessation. Write ℞ for smallest practical amount. Elderly (higher risk of falls). Debilitated. Pregnancy, nursing mothers: not recommended.

Sonata Pharmacokinetics

See Literature

Sonata Interactions


Concomitant other sedative-hypnotics at bedtime or middle of the night: not recommended. Potentiates CNS depression with alcohol, other CNS depressants; adjust dose. May be potentiated by CYP3A4 inhibitors (eg, erythromycin, ketoconazole) and drugs that inhibit aldehyde oxidase (eg, cimetidine, possibly diphenhydramine). May be antagonized by promethazine, CYP3A4 inducers (eg, rifampin, phenytoin, carbamazepine, phenobarbital); consider alternatives.

Sonata Adverse Reactions

Adverse Reactions

Headache, GI upset, abdominal pain, dizziness, somnolence; abnormal thinking and behavioral changes; rare: anaphylaxis, angioedema (do not rechallenge).

Sonata Clinical Trials

See Literature

Sonata Note

Not Applicable

Sonata Patient Counseling

See Literature