Overview

Trial of Zolpidem for Sleep in Children With Autism

Status:
Not yet recruiting
Trial end date:
2027-06-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborator:
National Institutes of Health (NIH)
Treatments:
Zolpidem
Criteria
Inclusion criteria:

Participants will meet the following

- Outpatients between 8 and 17 years of age

- 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)

- Males and females

- Availability of polysomnography (PSG) and actigraphy data

- Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with
a score of 41 or higher

- care provider who can reliably bring participant to clinic visits, provide trustworthy
ratings, and interacts with participant on a regular basis

- stable medications for at least 4 weeks

- no planned changes in psychosocial and biomedical interventions during the trial

- willingness to provide additional saliva samples and participate in key study
procedures (i.e., PSG and actigraphy at week 4 and 8, and safety measurements every
visit).

Exclusion criteria:

Participants will be excluded if one or more of the following is met

- active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective
disorder, or psychotic disorder

- active medical problems: migraine, asthma, seizure disorder, significant physical
illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology)

- evidence of a genetic mutation known to cause autism or intellectual disability (e.g.,
Fragile X Syndrome), metabolic, or infectious etiology for the participant's autism on
the basis of medical history, neurologic history, and available tests for inborn
errors of metabolism and chromosomal analysis

- pregnant or sexually active females not using a reliable method of contraception
(urinary tests for pregnancy will be employed in this study)

- individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic
medications, serotonin selective re-uptake inhibitors, melatonin and antihistamines

- history of hypersensitivity to zolpidem

- history of severe side effects from zolpidem

- history of adequate trial of zolpidem

- current use of any medications known to interact with zolpidem such as medications
inhibiting CYP3A4 and CYP1A2

- history of complex sleep-related behaviors