Trial of Zolpidem for Sleep in Children With Autism

Recruiting Phase 2 Interventional Study
Autism Autism Spectrum Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
8 – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
26 (estimated)
Sponsor
Stanford University · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion criteria: Participants will meet the following * Outpatients between 8 and 17 years of age with only 12- 17 years of age at time of consent during year 1 * Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluati…
Contacts

Ryan Villacrucis

(650) 736-1235

acesleepstudy@stanford.edu

CONTACT

Robin Libove, BS

(650) 736-1235

rlibove@stanford.edu

CONTACT