Trial of Zolpidem for Sleep in Children with Autism

Eligibility Criteria

• * 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)
• * 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).
• * 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, 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.