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RECRUITING
NCT05540574
PHASE2

Trial of Zolpidem for Sleep in Children With Autism

Sponsor: Stanford University

View on ClinicalTrials.gov

Summary

The purpose of this study is to examine the effect of zolpidem on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Zolpidem is a nonbenzodiazepine GABAa receptor agonist drug that acts as a hypnotic. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of zolpidem on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.

Official title: Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children With Autism

Key Details

Gender

All

Age Range

8 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2023-08-09

Completion Date

2028-04-30

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Zolpidem

5mg (and up to10mg) Diphenhydramine given orally

DRUG

Placebo

Matching Placebo given orally

Locations (1)

Stanford University

Stanford, California, United States