Trial of Zolpidem for Sleep in Children With Autism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zolpidem, Placebo.
- Who it may be relevant to
- Registry conditions: Autism, Autism Spectrum Disorder. Basic parameters: 8 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children With Autism
Overview
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.
Interventions
- Drug Zolpidem
5mg (and up to10mg) Diphenhydramine given orally - Drug Placebo
Matching Placebo given orally
Primary outcome measures
- Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM) [Time frame: Baseline, Week 4 and Week 8]
Secondary outcome measures (1)
- Change from baseline in sleep efficiency as measured by actigraphy [Time frame: Baseline, Week 4 and Week 8]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Stanford University — Stanford
Identifiers
NCT: NCT05540574 · IRB-67221 · 1P50HD109861