Trial of Zolpidem for Sleep in Children With Autism
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Zolpidem, then Placebo Participants will first receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. Participants will then receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. |
Drug: Zolpidem
5mg (and up to10mg) Diphenhydramine given orally
Other Names:
Drug: Placebo
Matching Placebo given orally
|
| Experimental: Placebo, then Zolpidem Participants will first receive Placebo (fake tablet) for a 4-week period. A 5 mg dose of matching Placebo will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. Participants will then receive Zolpidem for a 4-week period. A 5 mg dose of Zolpidem will be given at bedtime for one week and then will increase to 10 mg if needed and if well tolerated. |
Drug: Zolpidem
5mg (and up to10mg) Diphenhydramine given orally
Other Names:
Drug: Placebo
Matching Placebo given orally
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in sleep architecture as measured by polysomnography (PSG), examples include sleep latency and non-rapid eye movement (NREM) [Baseline, Week 4 and Week 8]
Secondary Outcome Measures
- Change from baseline in sleep efficiency as measured by actigraphy [Baseline, Week 4 and Week 8]
Other Outcome Measures
- Change from baseline on Children's Sleep Habits Questionnaire (CSHQ) subscale score [Baseline, Week 4 and Week 8]
- Change from baseline on Aberrant Behavior Checklist, Second Edition (ABC-2) subscale scores [Baseline, Week 4 and Week 8]
- Change from baseline on Parent Sleep Habits Questionnaire Parent (PSHQ) scores [Baseline, Week 4 and Week 8]
- Change from baseline on Clinical Global Impression Scale (CGI) scores [Baseline, Week 4 and Week 8]
- Change from baseline on Child Behavior Checklist (CBCL) scores [Baseline, Week 4 and Week 8]
- Change from baseline on Social Responsiveness Scale, Second Edition (SRS-2) scores [Baseline, Week 4 and Week 8]
- Change from baseline on Repetitive Behavior Scale - Revised (RBS-R) scores [Baseline, Week 4 and Week 8]
- Change from baseline on Sensory Profile Questionnaire (SPQ) scores [Baseline, Week 4 and Week 8]
- Change from baseline on Stanford Social Dimension Scale (SSDS) scores [Baseline, Week 4 and Week 8]
- Change from baseline on Dimensional Assessment of Repetitive Behaviors (DARB) scores [Baseline, Week 4 and Week 8]
- Change from baseline on NEuroPSYchological Assessment, 2nd Edition (NEPSY-2) Affect Recognition scores [Baseline, Week 4 and Week 8]
Eligibility Criteria
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)
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Males and females
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Availability of polysomnography (PSG) and actigraphy data
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Sleep disturbances as assessed using Children's Sleep Habits Questionnaire (CSHQ) with a score of 41 or higher
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care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interacts with participant on a regular basis
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stable medications for at least 4 weeks
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no planned changes in psychosocial and biomedical interventions during the trial
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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
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active suicidal ideation or DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
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active medical problems: migraine, asthma, seizure disorder, significant physical illness (e.g., anaphylaxis, serious liver, renal, or cardiac pathology)
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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
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pregnant or sexually active females not using a reliable method of contraception (urinary tests for pregnancy will be employed in this study)
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individuals taking beta-blockers (local or systemic), benzodiazepines, antiepileptic medications, serotonin selective re-uptake inhibitors, melatonin and antihistamines
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history of hypersensitivity to zolpidem
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history of severe side effects from zolpidem
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history of adequate trial of zolpidem
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current use of any medications known to interact with zolpidem such as medications inhibiting CYP3A4 and CYP1A2
-
history of complex sleep-related behaviors
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Stanford University
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Antonio Y. Hardan, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-67221