Trial of Diphenhydramine for Sleep in Children with Autism

Eligibility Criteria

• * Outpatients between 8 and 17 years of age at the time of consent
• * 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
• * 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).
• * 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)
• * 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 and antihistamines
• * history of hypersensitivity to diphenhydramine
• * history of severe side effects from diphenhydramine
• * history of adequate trial of diphenhydramine
• * current use of any medications known to interact with diphenhydramine such as medications inhibiting CYP2D6
• * taking anticholinergic agents (e.g., trihexyphenidyl, thioridazine).