Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

Phase 2 Completed 166 enrolled Idorsia Pharmaceuticals Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to \< 18 years with insomnia disorder.

Timeline

Start: 2022-09-06
Primary completion: 2026-01-12
Completion: 2026-02-05

Publications

Coloma P, Coury D, Wernette S, Beevers V, Dubois C, Di Marco T, Dursun OT, Bruni O. Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial. BMJ Open. 2026 Apr 6;16(4):e099888. doi: 10.1136/bmjopen-2025-099888.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daridorexant	Small molecule	10 mg	Oral
Subject	Daridorexant	Small molecule	25 mg	Oral
Subject	Daridorexant	Small molecule	50 mg	Oral

Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder

Summary

Timeline

Publications

Drugs

Indications