NCT05501678

Trial of Diphenhydramine for Sleep in Children With Autism

Randomized Placebo-controlled Crossover Trial of Diphenhydramine 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: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effect of diphenhydramine on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Diphenhydramine is an anti-histaminergic agent with strong hypnotic properties. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of diphenhydramine on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Conditions

• Autism
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Diphenhydramine	25mg (and up to 50mg) Diphenhydramine given orally
DRUG	Placebo	Matching Placebo given orally

Timeline

• Start date: 2023-08-09
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2022-08-15
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study