RecruitingPhase 2NCT05540574

Trial of Zolpidem for Sleep in Children With Autism

Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children With Autism

Sponsor

Stanford University

Enrollment

26 participants

Start Date

Aug 9, 2023

Study Type

INTERVENTIONAL

Conditions

Autism Autism Spectrum Disorder

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.

Eligibility

Min Age: 8 YearsMax Age: 17 Years

Inclusion Criteria11

Participants will meet the following
Outpatients between 8 and 17 years of age with only 12- 17 years of age at time of consent during year 1
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 Questionnaire (CSHQ) with a score of 41 or higher and sleep efficiency of 85% or less and/or total sleep time less than 7 hours and/or wake after sleep onset of more than 30 minutes as measured by polysomnography (PSG) or actigraphy.
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 2 weeks, with the exception of Prozac which is required to be stable 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., safety measurements every visit, PSG at weeks 4 and 8, and wear the actigraphy watch for 2 weeks before the beginning of trial as well as during the 8 weeks of the trial)
requirement of dual protection contraception use in females who are sexually active and are of childbearing potential. Dual use contraceptive methods involve the use of both a hormonal method (oral contraceptives, long-acting reversible contraceptives, etc.) and a barrier method (condoms).

Exclusion Criteria12

Participants will be excluded if one or more of the following is met
active suicidal ideation or DSM-5 diagnosis of severe depression, substance use disorder, schizophrenia, schizoaffective disorder, or psychotic disorder
unstable medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology) and hepatic insufficiency
evidence of a 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;
pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
individuals taking benzodiazepines, antiepileptic medications when prescribed for seizure disorder/epilepsy, antidepressants, melatonin and centrally-acting 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
individuals using alcohol, marijuana and other substances.