Idorsia’s insomnia drug Kuvivik (dalidrexant) moves one step closer to becoming a first-in-class treatment for children with a victory in a Phase 2 clinical trial.
The drug, a dual orexin receptor antagonist (DORA), was studied in insomniac children aged 10 to 17 with neurodevelopmental disorders such as autism spectrum disorder and attention-deficit hyperactivity disorder (ADHD).
Idorsia reported Monday that 165 patients who received doses of 10, 25, or 50 mg of Quviviq showed a dose-dependent improvement in total sleep time from baseline, as measured through a two-week polysomnographic sleep study.
“These positive results demonstrate for the first time that dalidorexant produces strong dose-dependent improvements in both objective and subjective sleep outcomes in children,” Alberto Jimona, MD, Idorcia’s global clinical development and medical affairs director, said in the release. “We have a wealth of data to analyze, and we look forward to discussions with health authorities to define the next steps for pediatric insomnia. As the only DORA being studied in children, dalidorexant has the potential to not only be best-in-class for adults, but also first-in-class for the pediatric population.”
Importantly, the trial’s safety data showed that the next morning after using the drug, “there was no residual drowsiness, but there was an improvement in alertness,” Jimona commented, citing “a visual analogue scale that allows patients and caregivers to estimate their child’s sense of morning sleepiness.”
Treatment options for childhood insomnia are limited, and there are no FDA-approved medications specifically for children. Between 10% and 30% of children and adolescents in the United States are affected by sleep disorders, with higher rates among those with neurodevelopmental disorders, Judith Owens, MD, professor emeritus of Harvard Medical School, explained in a release from Idosia.
Owens added that safety concerns surrounding the use of off-label sleeping medications approved for adults have long contributed to a treatment gap, given that clinicians are “understandably reluctant to use pharmacological options” to treat insomnia in children.
Idorcia will submit the results to the relevant health authorities and will also discuss with them the possibility of new research pathways for children with neurodevelopmental disorders based on the results.
Kubivic is classified as a controlled substance and was first introduced to the adult market with FDA approval in 2022 to compete with Merck’s dominant DORA sleeping pill Belsomra and Eisai’s Davigo. While Belsomra’s weak sales have proven the sleep market to be a difficult market to crack, Kvivic has shown a rapid growth trajectory so far. Sales of the drug, Idorsia’s first commercially available product, more than doubled from the previous year, generating 134 million Swiss francs ($167.2 million) in 2025.
All of this comes at a turbulent time for Switzerland-based Idorsia, which was founded in 2017 by Jean-Paul and Martine Crozel.
A new CEO was appointed in Maryland’s Srishti Gupta last July after CEO Andre Muller took the helm for a year. Earlier this month, Mr. Gupta also stepped down, leaving Jean-Paul Crozel to take the reins and assume day-to-day responsibilities while the board searches for a permanent replacement. The company cut nearly 200 jobs in 2025, ending the year with 487 full-time employees, the company said in its full-year results announcement.
