The Food and Drug Administration (FDA) has approved Quviviq™ (daridorexant) for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Daridorexant is a dual orexin receptor antagonist designed to suppress wake drive by blocking the binding of wake-promoting neuropeptides orexin A and orexin B to its receptors. 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.
Findings from Study 1 and Study 2 showed that daridorexant demonstrated statistically significant and clinically meaningful improvements in sleep onset, sleep maintenance, and patient reported total sleep time. Patients treated with daridorexant also had a significant reduction in daytime sleepiness, as assessed by a validated sleep diary questionnaire.
The safety profile of daridorexant was found to be comparable to placebo. The most common adverse reactions were headache and somnolence or fatigue. Daridorexant was not associated with next morning residual effects, rebound insomnia, or withdrawal symptoms upon discontinuation.
“Daridorexant properties include a potent inhibition of both orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic profile such that around 80% of daridorexant has been eliminated after a night of sleep to help minimize residual effects,” said Martine Clozel, MD and Chief Scientific Officer of Idorsia.
Quviviq is supplied as 25mg and 50mg tablets in 30-count bottles. The product is expected to be available in May 2022 following scheduling by the US Drug Enforcement Administration.
- Idorsia receives US FDA approval of Quviviq (daridorexant) 25 and 50 mg for the treatment of adults with insomnia. News release. Idorsia Pharmaceuticals Ltd. Accessed January 10, 2022. https://www.globenewswire.com/news-release/2022/01/10/2363527/0/en/Idorsia-receives-US-FDA-approval-of-QUVIVIQ-daridorexant-25-and-50-mg-for-the-treatment-of-adults-with-insomnia.html
- Quviviq. Package insert. Idorsia Pharmaceuticals Ltd; 2021. Accessed January 10, 2022. https://www.idorsia.us/documents/us/label/Quviviq_PI.pdf