Daridorexant (Quviviq)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Quviviq not be reimbursed by public drug plans for the management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
• Evidence from 2 clinical trials (Study 301 and Study 302) in adults with chronic insomnia disorder (CID) showed that treatment with Quviviq resulted in improvements in the time it takes to fall asleep, the time spent awake after initially falling asleep, and the total sleep duration compared with placebo. However, it was uncertain whether the results were clinically meaningful based on the suggested minimal important differences (MIDs).
• Patients identified a need for treatments that provide consistent, restorative sleep, minimize daytime sedation, and carry a low risk of dependency or cognitive side effects. However, based on the evidence reviewed in the initial meeting and the reconsideration meeting, the Canadian Drug Expert Committee (CDEC) could not determine whether Quviviq meets these needs. The uncertainty was mainly due to a lack of meaningful effect compared to placebo as well as no direct or indirect evidence compared to other treatments used for insomnia.