Age

2–17

Sex

ALL

Healthy volunteers

Not accepted

Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
Confirmed clinical diagnosis of insomnia disorder
Males and Females between 2 and 17 years, inclusive.
The sleep disturbance must not be a result of another medication.

Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
Indication of impaired liver function.
Pregnant or lactating females.
A positive test for drugs of abuse.

Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia