Phase 2 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 8 and 17 years old and are seen as an outpatient (not staying in hospital); note that during the first year of the trial, only those aged 12–17 at the time of signing up will be included
• You have been diagnosed with Autism Spectrum Disorder (ASD) based on a clinical assessment and confirmed using specific standardised diagnostic tools
• Both males and females may participate
• You have sleep problem data available, or are able to have it collected through overnight sleep monitoring or a wrist-worn activity tracker
• You have sleep difficulties, shown by a score of 41 or higher on a standard sleep questionnaire, and/or poor sleep efficiency, and/or sleeping less than 7 hours, and/or waking for more than 30 minutes after first falling asleep
• You have a caregiver who can reliably bring you to clinic visits, give accurate feedback, and spends regular time with you
• Any medications you currently take have been at a stable dose for at least 2 weeks (or at least 4 weeks if you take Prozac/fluoxetine)
• You and your caregiver agree not to make changes to any current treatments or therapies during the trial
• You are willing to give saliva samples, attend safety check appointments at every visit, take part in overnight sleep studies at weeks 4 and 8, and wear a sleep-tracking watch for 2 weeks before and throughout the 8-week trial
• If you are female, sexually active, and able to become pregnant, you are willing to use two forms of contraception at the same time (one hormonal method and one barrier method, such as the pill plus condoms)

Who may not be able to join:

• You are currently having thoughts of suicide, or have a diagnosis of severe depression, a substance use disorder, schizophrenia, schizoaffective disorder, or a psychotic disorder
• You have unstable health conditions such as migraines, asthma, seizures, a serious illness (for example, severe allergic reactions, or significant liver, kidney, or heart problems), or liver insufficiency
• There is evidence that your autism may be caused by a metabolic or infectious condition, based on your medical or neurological history or test results
• You are pregnant, or you are female, sexually active, and not using a reliable form of contraception (pregnancy urine tests will be used in this study)
• You are currently taking benzodiazepines, anti-seizure medications (when prescribed for epilepsy), antidepressants, melatonin, or certain antihistamines that affect the brain
• You have had an allergic reaction to zolpidem in the past
• You have previously had severe side effects from taking zolpidem
• You have already had a full, adequate course of treatment with zolpidem
• You are currently taking any medications known to interact with zolpidem, including certain drugs that affect how the body processes medications (confirm with trial site)
• You have a history of unusual or complex behaviours during sleep (such as sleepwalking or acting out during sleep)
• You currently use alcohol, marijuana, or other substances

Important: Always verify eligibility with the trial site directly before applying.