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Study details
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Trial of Zolpidem for Sleep in Children With Autism

Stanford University
NCT IDNCT05540574ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

26

Study length

about 4.7 years

Ages

8–17

Locations

1 site in CA

What this study is about

Researchers are testing whether zolpidem helps children with autism sleep better. The trial will compare zolpidem to a placebo (an inactive pill) over 8 weeks, using tests like polysomnography and actigraphy to measure sleep patterns.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Placebo
  • 2.Take Zolpidem

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

zolpidem (Non-benzodiazepine hypnotic; enhances GABA to induce sleep)

Endpoints

Primary: Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)

Secondary: Change from baseline in sleep efficiency as measured by actigraphy

Body systems

Psychiatry / Mental Health