Insomnia Study for Children and Teens

Tasimelteon vs Placebo

Study Specific Details:

Tasimelteon vs Placebo with option of open-label phase.
4 office visits and 4 tele-visits over a 12-week period.
Participants are reimbursed $100 per office visit and $25 per tele-visit for their time and travel at the end of each completed visit.

DSM-V diagnosis of Insomnia.
Any male or female between 2-17 years of age.
Sleep latency of at least 1 hour on average, 4 nights per week, for at least 3 months.
Willing to complete a daily sleep diary.
Stimulants and nonstimulants are allowed for ADHD but must be taken in the morning.

The sleep disturbance and associated daytime symptoms are a result of another sleep disorder, medical disorder, mental disorder, medication, or substance use.
Sleep disturbance and associated daytime symptoms occur less than 4 times per week.
Use of prohibited medications. Antidepressants, anticonvulsants, antipsychotics, and psychotropic medications that are being used for sleep or have sleep-promoting properties are not allowed.
Unwilling to take study medication. Oral suspension.

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