Sleep-wake disorders:

Indications for: SONATA

Short-term treatment of insomnia.

Adult Dosage:

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.

Children Dosage:

Not established.

SONATA Contraindications:

Prior history of complex sleep behaviors with Sonata.

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 Classification:

Pyrazolopyrimidine hypnotic.

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.

Adverse Reactions:

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

Generic Drug Availability:


How Supplied: