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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Placebo
  • 2.Take Zolpidem
PhasePhase 2
DrugZolpidem
Primary goalChange from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low8%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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