Trial of Zolpidem for Sleep in Children With Autism

Launched by STANFORD UNIVERSITY · Sep 12, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how well a medication called zolpidem can help improve sleep in children and teenagers with Autism Spectrum Disorder (ASD). Zolpidem is a type of sleep medication that works by helping to calm the brain and promote sleep. The study will last for eight weeks and will involve participants trying both zolpidem and a placebo (a harmless pill with no active medication) at different times. Researchers will monitor sleep patterns using special equipment and questionnaires to see if zolpidem helps improve sleep quality.

To join this study, participants must be between 8 and 17 years old and have a confirmed diagnosis of ASD. They should also have trouble sleeping, as measured by a specific questionnaire. It’s important that they haven’t changed their medications for at least four weeks before joining the study. Participants will need to attend regular clinic visits and wear a special watch to track their sleep. Additionally, females who are sexually active must use reliable birth control during the study. This trial aims to provide valuable insights into better sleep solutions for children with ASD.

Gender

ALL

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.