This study is testing a liquid medicine called tasimelteon against a placebo (an inactive substance) to see if it helps children and teenagers with insomnia disorder sleep better. Researchers want to find out if tasimelteon is safe and effective for kids aged 2 to 17 years old. To join, you or your child must have a diagnosis of insomnia disorder that isn't caused by other medications. The main goal is to see if tasimelteon changes how long it takes for participants to fall asleep, as recorded in a daily sleep diary over 12 weeks. The current recruitment status is unclear, but the study plans to enroll 420 participants.

Study design

This is a multicenter, double-blind (meaning neither you nor your doctor will know if you're receiving tasimelteon or placebo), randomized study. It plans to enroll 420 participants.

What's involved

You or your child would take a single daily dose of either tasimelteon oral suspension or a placebo. You would also keep a daily sleep diary for 12 weeks.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint is measured at 12 weeks, which suggests follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.