10 January 2022 - The approval of Quviviq – 25 & 50 mg – is based on a robust Phase 3 clinical program that demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, as well as patient reported total sleep time.
Idorsia today announced that the US FDA has approved Quviviq (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterised by difficulties with sleep onset and/or sleep maintenance.