Using zolpidem to improve sleep in children with autism
Randomized Placebo-Controlled Crossover Trial of Zolpidem for Sleep in Children With Autism
This study is testing if a sleep medication called zolpidem can help improve sleep quality in children and teens with autism who have trouble sleeping.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05540574 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 8 to 17 years with a confirmed diagnosis of Autism Spectrum Disorder and significant sleep disturbances.
Not a fit: Patients without sleep disturbances or those who do not meet the diagnostic criteria for Autism Spectrum Disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for improving sleep in children with autism, potentially enhancing their overall quality of life.
How similar studies have performed: While there have been studies on sleep interventions in autism, the specific use of zolpidem in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stanford, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.