Randomized Placebo-Controlled Crossover Trial of Suvorexant for Sleep in Children With Autism
Stanford University
Summary
The purpose of this study is to examine the effect of suvorexant on sleep in children and adolescents with Autism Spectrum Disorder (ASD). Suvorexant is a selective, dual orexin receptor antagonist (DORA) used for the treatment of sleep onset difficulties and/or sleep maintenance. To accomplish this, the investigators will use a randomized double-blind placebo-controlled crossover 8-week study design to examine the effect of suvorexant on sleep physiology as assessed by polysomnography (PSG), actigraphy, circadian rhythm, and clinical measures.
Eligibility
- Age range
- 13–17 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion criteria: Participants will meet the following * Outpatients between 13 and 17 years of age at time of consent * Diagnostic and Statistical Manual, 5th edition (DSM-5) criteria for Autism Spectrum Disorder (ASD) on the basis of clinical evaluation, confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule, 2nd Ed (ADOS-2) or the Childhood Autism Rating Scale, Second Edition (CARS-2) * Males and females * Availability of polysomnography (PSG) and/or actigraphy data * Sleep disturbances as assessed using Children's Sleep Habits Ques…
Interventions
- DrugSuvorexant
5 mg (and up to 20 mg) Suvorexant given orally
- DrugPlacebo
Matching Placebo given orally
Location
- Stanford UniversityStanford, California