RecruitingInsomnia Disorder

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

Eligible age

2–17 yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

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About this study

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

Sponsor: Vanda Pharmaceuticals

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.