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

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Insomnia Disorder

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

2 to 17 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Vanda Pharmaceuticals

Last updated on ClinicalTrials.gov

June 5, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites