Daridorexant

FDA Drug Profile — QUVIVIQ

Drug Details

Generic Name
Daridorexant
Brand Names
QUVIVIQ
Application Number
NDA214985
Sponsor
Idorsia Pharmaceuticals Ltd
NDC Codes
2
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
DARIDOREXANT

Indications and Usage

1 INDICATIONS AND USAGE QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1) ] . QUVIVIQ is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )