The US Food and Drug Administration has approved a new medication for the treatment of insomnia.
The US Food and Drug Administration (FDA) has approved Idorsia’s daridorexant (Quviviq) 25 mg and 50 mg for the treatment of adult patients with insomnia. The approval is based on an extensive clinical program that included more than 160 clinical trials and 1854 adult participants with insomnia across 18 countries.
Daridorexant is a dual orexin receptor antagonist. It blocks the binding of the wake-promoting neuropeptides orexins and may turn down overactive wakefulness.
“After more than 20 years of research and a progressive understanding of the role of orexin in sleep-wake balance and of the potential of orexin receptor antagonism, we designed daridorexant to help address several issues people with insomnia face. 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, Chief Scientific Officer of Idorsia.
Daridorexant demonstrated significant improvement when compared with placebo on objective measures of sleep onset, sleep maintenance, and patient reported total sleep time during the phase 3 clinical program. The 50 mg dose of daridorexant was evaluated in 1 of the 2 pivotal studies, and demonstrated a significant reduction in patient reported daytime sleepiness as measured by a validated instrument. The most common adverse reactions were headache and somnolence or fatigue.
The Head of Global Clinical Development of Idorsia, Guy Braunstein, MD, stated: “In our investigation of daridorexant we were able to demonstrate an improvement on objective sleep parameters, as well as improvement in patient-reported outcomes. What is truly impressive, we have shown a dose response in the efficacy of daridorexant, with no increase in the rate of somnolence or fatigue with increasing doses.”
The FDA has recommended that Quviviq be classified as a controlled substance. It is expected to be available to patients in May 2022.
“As noted in the definition of insomnia, the disorder is not only a problem of the night but affects a patient’s ability to function during the day. Although the personal and societal burden of insomnia is well established, elevating the impact insomnia has on both the night and day remains critical in addressing patients’ needs. I am encouraged to see a new advanced treatment option for the millions of adults struggling with insomnia,” said Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital.
1. Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia. Idorsia. News release. January 10, 2022. Accessed January 11, 2022. https://www.idorsia.com/media/news-details?newsId=2665386