Education and Training

Trial of Zolpidem for Sleep in Children With Autism

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.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Zolpidem
  • drug: Placebo

Eligibility


Inclusion criteria:

Participants will meet the following

   - Outpatients between 8 and 17 years of age with only 12 to 17 years of age 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)

   - 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 and sleep efficiency of 80% or less

   - 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., 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 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), and hepatic
   insufficiency

   - 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, antihistamines and
   antidepressants

   - 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.

Ages Eligible for Study

8 Years - 17 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Joe McGrath
650-736-1235
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