After notching a phase 2 trial win, Idorsia’s insomnia med Quviviq (daridorexant) is one step closer to potentially becoming a first-in-class treatment for children.
The drug, a dual orexin receptor antagonist (DORA), was studied in children with insomnia between the ages of 10 and 17 years old, including those with neurodevelopmental disorders such as autism spectrum disorder and attention-deficit/hyperactivity disorder (ADHD).
As measured through a two-week polysomnography sleep study, 165 patients who received a 10-, 25- or 50-mg dose of Quviviq experienced dose-dependent improvements in total sleep time from baseline, Idorsia reported on Monday.
“These positive results show for the first time that daridorexant delivers strong, dose‑dependent improvements in both objective and subjective sleep outcomes in children,” Idorsia’s head of global clinical development and medical affairs, Alberto Gimona, M.D., said in a release. “With a wealth of data to analyze, I’m looking forward to the discussions with health authorities to define the next steps in pediatric insomnia. As the only DORA being investigated in children, daridorexant could become not only best‑in‑class for adults, but first‑in‑class for the pediatric population.”
Importantly, safety data from the trial show that there was “no residual sleepiness but improved alertness” in the morning after the use of the drug, Gimona commented, citing a “visual analog scale where patients and caregivers estimate the feeling of the child’s morning sleepiness.”
Treatment options for pediatric insomnia are limited, with no FDA-approved medications meant specifically for children. Between 10% and 30% of U.S. children and adolescents are impacted by the sleep disorder, with higher rates seen among those with neurodevelopmental disorders, Harvard Medical School professor Emerita Judith Owens, M.D., explained in Idorsia’s release.
Safety concerns tied to the use of off-label sleep meds approved for adults have long fostered a treatment gap, given that clinicians are “understandably reluctant to use pharmacologic options” to treat insomnia in children, Owens added.
Idorsia plans to present the results to relevant health authorities and will also discuss with them a new potential investigation pathway for children with neurodevelopmental disorders based on the results.
Quviviq is classified as a controlled substance and first hit the market for adults with its 2022 FDA approval, challenging Merck’s reigning DORA sleep med Belsomra and Eisai’s Dayvigo. Belsomra’s lackluster sales proved that the sleep market is a difficult one to crack, but Quviviq is so far showing a speedy growth trajectory. The drug, which was Idorsia’s first commercial product, more than doubled its sales year over year, generating CHF 134 million ($167.2 million) in 2025.
All this comes at a turbulent time for Swiss-based Idorsia, which was established by husband-and-wife team Jean-Paul and Martine Clozel in 2017.
After one year of CEO André Muller manning the helm, a new CEO was named last July in Srishti Gupta, M.D. Earlier this month, Gupta hit the exit as well, leaving Jean-Paul Clozel to take the reins and handle day-to-day responsibilities as the board searches for a permanent replacement. The company cut nearly 200 jobs in 2025 and ended the year with 487 full-time staffers, it said in its full-year results announcement.