trial of zolpidem for sleep in children with autism

Conditions: Autism; Autism Spectrum Disorder

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.


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) * 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 85% 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 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 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.

Keywords: zolpidem sleep clinical trial autism