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Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised

Preciosa Coloma1, Daniel Coury2, Sophie Wernette3

  • 1Global Clinical Development, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland drugdiva@gmail.com tobias.dimarco@outlook.com.

BMJ Open
|April 6, 2026
PubMed

Insights

This study evaluates daridorexant, a novel insomnia treatment, in children and adolescents. It assesses safety and efficacy in a broad pediatric population, including those with neurodevelopmental disorders.

Area of Science:

  • Pediatric Sleep Medicine
  • Pharmacology
  • Neuroscience

Background:

  • Insomnia disorder significantly impacts children and adolescents, with limited treatment options.
  • Dual orexin receptor antagonists represent a novel therapeutic approach for insomnia.
  • This study investigates daridorexant in a broad pediatric population, including those with neurodevelopmental disorders.

Purpose of the Study:

  • To evaluate the efficacy and safety of daridorexant in pediatric patients with insomnia disorder.
  • To determine the dose-response relationship of daridorexant in this population.
  • To assess daridorexant's tolerability, pharmacokinetics, and acceptability in children and adolescents.

Main Methods:

  • A multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose-finding Phase 2 trial.
  • Participants aged 10 to <18 years with insomnia disorder were stratified based on neurodevelopmental status (autism spectrum disorder, attention-deficit hyperactivity disorder).
  • Randomization to daridorexant (10, 25, or 50 mg) or placebo for at least 14 days, with polysomnography measuring total sleep time as the primary endpoint.

Main Results:

  • The study characterized the dose-response relationship of daridorexant for total sleep time.
  • Safety, tolerability, pharmacokinetics, palatability, and acceptability were assessed.
  • Results will be published in a peer-reviewed journal.

Conclusions:

  • Daridorexant is being evaluated as a potential new treatment for insomnia disorder in children and adolescents.
  • The study provides insights into the efficacy and safety profile of daridorexant in a diverse pediatric population.
  • Further research may establish daridorexant as a valuable therapeutic option for pediatric insomnia.
Abstract

Keywords:
AdolescentAttention Deficit Disorder with HyperactivityChildClinical ProtocolsInsomniaSLEEP MEDICINE

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