suvorexant

FDA Drug Profile — BELSOMRA

Drug Details

Generic Name
suvorexant
Brand Names
BELSOMRA
Application Number
NDA204569
Sponsor
Merck Sharp & Dohme LLC.
NDC Codes
8
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
SUVOREXANT

Indications and Usage

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