Actively Recruiting
Trial of Zolpidem for Sleep in Children With Autism
Led by Stanford University · Updated on 2026-03-27
26
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of Zolpidem for Sleep in Children With Autism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 8 to 17 years (12 to 17 years old at consent during year 1)
- Diagnosed with Autism Spectrum Disorder (ASD) confirmed by clinical evaluation and standardized diagnostic tools (ADI-R, ADOS-2, or CARS-2)
- Both males and females eligible
- Availability of polysomnography (PSG) and/or actigraphy sleep data
- Sleep disturbances identified by Children's Sleep Habits Questionnaire (CSHQ) score of 41 or higher and sleep efficiency of 85% or less and/or total sleep time under 7 hours and/or wake after sleep onset over 30 minutes measured by PSG or actigraphy
- Caregiver able to reliably bring participant to visits, provide accurate ratings, and have regular interaction
- Stable medications for at least 2 weeks, except Prozac which requires 4 weeks stability
- No planned changes in psychosocial or biomedical treatments during the study
- Willingness to provide saliva samples and participate in study procedures including safety checks at every visit, PSG at weeks 4 and 8, and wearing actigraphy watch before and during the trial
- Female participants who are sexually active and of childbearing potential must use dual contraceptive methods
You will not qualify if you...
- Active suicidal thoughts or diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
- Unstable medical conditions such as migraine, asthma, seizure disorder, serious liver, kidney, or heart problems, or liver failure
- Evidence of metabolic or infectious causes for autism
- Pregnant females or sexually active females not using reliable contraception
- Use of benzodiazepines, antiepileptic drugs for seizure disorders, antidepressants, melatonin, or centrally-acting antihistamines
- Known allergy or severe side effects from zolpidem
- Previous adequate trial of zolpidem
- Current use of medications that interact with zolpidem (e.g., CYP3A4 and CYP1A2 inhibitors)
- History of complex sleep-related behaviors
- Use of alcohol, marijuana, or other substances
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305-5719
Actively Recruiting
Research Team
R
Ryan Villacrucis
CONTACT
R
Robin Libove, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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