Using zolpidem to improve sleep in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines the effects of zolpidem, a nonbenzodiazepine hypnotic, on sleep in children and adolescents diagnosed with Autism Spectrum Disorder (ASD). It employs a randomized double-blind placebo-controlled crossover design over 8 weeks, utilizing polysomnography (PSG), actigraphy, and clinical measures to assess sleep physiology and disturbances. Participants will include outpatients aged 8 to 17 years who meet specific diagnostic criteria and have documented sleep issues. The goal is to determine if zolpidem can effectively enhance sleep quality in this population.

Why it matters

Who can join: the full rules

Inclusion criteria:

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 criteria:

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.

Where it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Antonio Y. Hardan, MD — Stanford University
• Study coordinator: Ryan Villacrucis
• Email: acesleepstudy@stanford.edu
• Phone: (650) 736-1235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.