Sleep-wake disorders:

Indications for: BELSOMRA

Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Adult Dosage:

Use lowest effective dose. Take within 30mins of bedtime if able to get full night’s sleep (≥7hrs) before awakening. 10mg once per night; may increase if ineffective; max 20mg once daily. Concomitant moderate CYP3A inhibitors: 5mg once daily; max 10mg once daily. Effect may be delayed if taken with or soon after a meal.

Children Dosage:

Not established.

BELSOMRA Contraindications:


BELSOMRA Warnings/Precautions:

Monitor for CNS depression, somnolence; discontinue or reduce dose if daytime somnolence develops. Risk of next-day impairment (including impaired driving). Discontinue immediately if complex sleep behaviors develop. Depression. Monitor for suicidal ideation. Compromised respiratory function (eg, COPD, obstructive sleep apnea). Increased risk of exposure-related effects in obese women. Monitor for worsening insomnia or abnormal thinking and behavioral changes. Reevaluate if unresponsive after 7–10 days of treatment. Severe hepatic impairment: not recommended. Drug or alcohol abusers. Elderly. Pregnancy. Nursing mothers.

BELSOMRA Classification:

Orexin receptor antagonist.

BELSOMRA Interactions:

Avoid alcohol. Potentiates CNS depression with other CNS depressants (eg, benzodiazepines, opioids, tricyclic antidepressants, alcohol); may need to adjust doses. Concomitant strong CYP3A inhibitors (eg, ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan): not recommended. Concomitant moderate CYP3A inhibitors (eg, amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil): reduce dose (see Adults). May be antagonized by strong CYP3A inducers (eg, rifampin, carbamazepine, phenytoin). Monitor digoxin.

Adverse Reactions:

Somnolence, headache, dizziness; complex sleep behaviors (eg, sleep-driving), sleep paralysis, hallucinations, cataplexy-like symptoms.

Generic Drug Availability:


How Supplied: