NCT05546554

Trial of Suvorexant for Sleep in Children With Autism

Randomized Placebo-Controlled Crossover Trial of Suvorexant for Sleep in Children With Autism

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Conditions

• Autism
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Suvorexant	5 mg (and up to 20 mg) Suvorexant given orally
DRUG	Placebo	Matching Placebo given orally

Timeline

• Start date: 2023-08-09
• Primary completion: 2028-02-28
• Completion: 2028-02-28
• First posted: 2022-09-21
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study