BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (1).

• Use the lowest dose effective for the patient (2.1).
• Recommended dose is 10 mg, no more than once per night taken within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not effective, the dose can be increased, not to exceed 20 mg once daily (2.1, 2.2).
• Time to effect may be delayed if taken with or soon after a meal (2.5).

Tablets, 5 mg, 10 mg, 15 mg, 20 mg (3).

• Do not use in patients with narcolepsy (4).

• Daytime somnolence: Risk of impaired alertness and motor coordination, including impaired driving; risk increases with dose; caution patients taking 20 mg against next-day driving and other activities requiring complete mental alertness (5.1).
• Need to eva luate for co-morbid diagnoses: Reeva luate if insomnia persists after 7 to 10 days of treatment (5.2).
• Nighttime "sleep-driving" and other complex behaviors while out of bed and not fully awake. Risk increases with dose, with use of CNS depressants, and with alcohol (5.3).
• Depression: Worsening of depression or suicidal thinking may occur. Risk increases with dose. Immediately eva luate any new behavioral changes (5.4).
• Compromised respiratory function: Effect on respiratory function should be considered (5.5, 8.6).
• Sleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-like symptoms: Risk increases with dose (5.6).

The most common adverse reaction (reported in 5% or more of patients treated with BELSOMRA and at least twice the placebo rate) with BELSOMRA was somnolence (6.1).
 

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• CYP3A inhibitors: Recommended dose is 5 mg when used with moderate CYP3A inhibitors. Dose can be increased to 10 mg once daily if the 5 mg dose is not effective. Not recommended for use in patients taking strong CYP3A inhibitors (2.4, 7.2).
• Strong CYP3A inducers: Efficacy may be reduced (7.2).
• Digoxin: Monitor digoxin concentrations (7.3).

• Pregnancy: Based on animal data, may cause fetal harm (8.1).
• Patients with severe hepatic impairment: Not recommended (8.7).