General Information

Quviviq (daridorexant) is an orexin receptor antagonist.

Quviviq is specifically indicated for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Quviviq is supplied as tablets for oral administration. The recommended dosage is 25 mg to 50 mg once per night, taken orally within 30 minutes before going to bed, with at least 7 hours remaining prior to planned awakening.

Time to sleep onset may be delayed if taken with or soon after a meal.

In patients with moderate hepatic impairment the maximum recommended dosage is 25 mg no more than once per night. In patients with severe hepatic impairment Quviviq is not recommended.

Mechanism of Action

The mechanism of action of daridorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

Clinical Trial Results

The efficacy of Quviviq was evaluated in two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, Study 1 and Study 2. and

A total of 1,854 patients with insomnia according to DSM-5 were randomized to receive Quviviq or placebo once daily, in the evening, for 3 months. Study 1 equally randomized 930 subjects to Quviviq 50 mg, 25 mg or placebo. Study 2 equally randomized 924 subjects to Quviviq 25 mg, 10 mg or placebo. At the end of the 3-month treatment period, both studies included a 7-day placebo run-out period, after which patients could enter a 9-month, double-blind, placebo-controlled extension study. A total of 600 subjects were treated for at least 6 months of cumulative treatment, including 373 treated for at least 12 months. Primary efficacy endpoints for both studies were the change from baseline to Month 1 and Month 3 in Latency to Persistent Sleep (LPS) and Wake After Sleep Onset (WASO), measured objectively by polysomnography in a sleep laboratory. LPS is a measure of sleep induction and WASO is a measure of sleep maintenance.

In Study 1, doses of 25 and 50 mg Quviviq showed a statistically significant improvement versus placebo on LPS and WASO and self-reported total sleep (sTST), at Month 1 and Month 3. In Study 2, Quviviq 25 mg showed a statistically significant improvement versus placebo on WASO and sTST at Month 1 and Month 3. Quviviq 10 mg did not show a statistically significant improvement on LPS, WASO, or sTST at Month 1 or Month 3.

The 50 mg dose of Quviviq also demonstrated significant reduction in daytime sleepiness compared to placebo, as measured by the sleepiness domain score from the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)7 at month 1 and month 3, a key secondary endpoint.