Overview
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
Eligibility
Inclusion Criteria:
- Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
- A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances.
- The sleep disturbance must not be a result of another diagnosable disorder or medication.
- Male or female between 2 and 65 years of age, inclusive.
- Willing and able to comply with study requirements and restrictions.
Exclusion Criteria:
- Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
- Indication of impaired liver function.
- Evidence of increased risk of self-harm.
- Pregnant or lactating females.
- A positive test for drugs of abuse.
- Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.