RecruitingPhase 2NCT05540574

Trial of Zolpidem for Sleep in Children With Autism

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


Sponsor

Stanford University

Enrollment

26 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether zolpidem (a sleep medication) can improve sleep in children and teenagers with autism spectrum disorder (ASD) who have significant sleep problems. Sleep difficulties are extremely common in autism and can worsen behavior, learning, and family quality of life. You may be eligible if: - Your child is between 8 and 17 years old (12-17 during the first year of the study) - Your child has a confirmed diagnosis of autism spectrum disorder - Your child has clinically significant sleep problems (confirmed by questionnaire and sleep study or actigraphy) - Medications have been stable for at least 2 weeks (or 4 weeks for Prozac) You may NOT be eligible if: - Your child has active suicidal thoughts, schizophrenia, or a severe substance use disorder - Your child has unstable medical conditions such as seizure disorder, serious liver, kidney, or heart problems - Your child is pregnant or sexually active without reliable contraception - Your child is taking benzodiazepines, certain antiepileptics, antidepressants, melatonin, or medications that interact with zolpidem - Your child has a history of severe side effects or an adequate prior trial of zolpidem Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZolpidem

5mg (and up to10mg) Diphenhydramine given orally

DRUGPlacebo

Matching Placebo given orally


Locations(1)

Stanford University

Stanford, California, United States

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NCT05540574


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