Idorsia's daridorexant shows positive Phase II results in pediatric insomnia disorder study

Idorsia Ltd, based in Allschwil, Switzerland, reported positive top-line results from a Phase II dose-finding study of daridorexant in pediatric patients aged 10 to 17 years with insomnia disorder, according to a [press release](https://www.globenewswire.com/news-release/2026/03/30/3264283/0/en/Idorsia-s-daridorexant-delivers-outstanding-results-in-a-Phase-2-study-in-children-with-insomnia-disorder.html) issued March 30. The company said the study met its primary endpoint, showing a statistically significant dose-dependent improvement in objective total sleep time on Day 1, as measured by polysomnography. This is the first controlled clinical dataset for daridorexant in a pediatric population. The [study (NCT05423717)](https://app.allsci.com/clinical-trial/ASC-CT-0000000026931-1.0-1745700230) randomized 165 patients in a 1:1:1:1 ratio to receive 10, 25, or 50 mg daridorexant or placebo for two weeks. Analysis of the primary endpoint — change from baseline in total sleep time on Day 1 — yielded a p-value of 0.0185 for the dose-response relationship. Idorsia reported additional dose-dependent improvements across multiple objective and subjective sleep parameters but did not disclose the magnitude of change in total sleep time or numerical results for secondary endpoints. On safety, the company said the profile at all doses, including 50 mg, was similar to placebo, with no adverse events denoting drug abuse during treatment and no indication of withdrawal symptoms upon discontinuation. The company also stated that a visual analog scale assessing next-morning residual effect showed no residual sleepiness. No adverse event rates or detailed safety tables were provided. The double-blind, placebo-controlled trial enrolled children aged 10 to 11 (21%) and 12 to 17 (79%), including patients with co-morbid neurodevelopmental disorders such as autism spectrum disorder and attention-deficit/hyperactivity disorder. The company noted that efficacy appeared especially pronounced in the neurodevelopmental subgroup, though no subgroup-specific numerical data were disclosed. The data remain interim top-line results from a two-week treatment period in a relatively small sample; the company did not disclose response rates, effect sizes, or longer-term follow-up data. Detailed results are expected at future congresses and in peer-reviewed publications. The study forms part of an FDA-approved Pediatric Study Plan and an EU PDCO-approved Paediatric Investigation Plan, and Idorsia said it will engage with regulators to discuss next steps. Daridorexant is a dual orexin receptor antagonist that suppresses wakefulness by blocking orexin signaling, a mechanism distinct from older hypnotics such as zolpidem, a GABA-A receptor modulator that reduces sleep latency by approximately 15 to 20 minutes versus placebo in adults. There are currently no FDA-approved medications for pediatric insomnia. Suvorexant, another dual orexin receptor antagonist approved for adult insomnia, improved sleep efficiency by 5 to 13 percentage points over placebo at one month in pivotal [Phase III trials](https://app.allsci.com/clinical-trial/ASC-CT-0000000026931-1.0-1745700230), but has not been studied in a controlled pediatric trial. Cross-trial comparisons are limited by differences in study design, duration, and patient populations. --- Spot something wrong? [Report an issue with this article](https://newsgen-prod.reframedata.com/feedback/daridorexant-pediatric-insomnia-idorsias-shows)