Quviviq

The approval was based on data from a comprehensive development program that included 2 pivotal phase 3 studies (ClinicalTrials.gov Identifier: NCT03545191 [Study 1] and NCT03575104 [Study 2]). The multicenter, double-blind phase 3 studies compared the efficacy and safety of daridorexant to placebo in 1854 patients 18 years of age and older with insomnia for 3 months. 

Study 1

The multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of daridorexant in 930 patients (39.1% ≥65 years of age) with insomnia. Patients were randomly assigned to receive daridorexant 25mg, 50mg or placebo orally once in the evening for 3 months. The coprimary endpoints were the change from baseline to months 1 and 3 in sleep onset, as measured by a decrease in latency to persistent sleep, and sleep maintenance, as measured by a decrease in wake time after sleep onset. A key secondary end point was subjective total sleep time (sTST), measured daily with a patient diary at home.

Results showed that daridorexant 25mg and 50mg significantly improved sleep onset and sleep maintenance at months 1 and 3 compared with placebo, which was assessed objectively in a sleep lab by polysomnography. Additionally, both doses of daridorexant significantly increased sTST from baseline. Patients treated with daridorexant 50mg also demonstrated a significant improvement in daytime performance at months 1 and 3.

Study 2

The multicenter, double-blind, placebo-controlled study evaluated the efficacy and safety of daridorexant in 924 adult patients (39.3% ≥65 years of age) with insomnia. Patients were randomly assigned to receive either daridorexant 10mg, 25mg, or placebo once in the evening. The coprimary endpoints were the change from baseline to months 1 and 3 in sleep onset, as measured by a decrease in latency to persistent sleep, and sleep maintenance, as measured by a decrease in wake time after sleep onset. 

Findings showed that daridorexant 25mg significantly improved sleep maintenance at months 1 and 3 compared with placebo, as measured objectively in a sleep lab by polysomnography. Daridorexant 25mg also significantly improved sTST (key secondary endpoint), as measured daily with a patient diary at home. 

Additionally, improvements in sleep onset and daytime functioning consistent with that seen in the first phase 3 trial were also observed with the 25mg dose, however, these endpoints did not reach statistical significance. While the 10mg dose of daridorexant was associated with improvements across all efficacy measures, these were not found to be statistically significant.

Effects on Driving

A randomized, double-blind, placebo- and active-controlled, 4-way crossover study evaluated the effects of nighttime administration of Quviviq on next-morning driving performance. Zopiclone 7.5mg was used as an active comparator. Findings showed both Quviviq 50mg and 100mg caused a statistically significant impairment in next morning driving performance in adult or elderly participants (compared with placebo) after the first dose. After 4 consecutive nights of treatment, the mean effect on driving performance was not statisitcally significant (vs placebo), however driving ability was impaired in some participants after taking Quviviq.