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

Launched by VANDA PHARMACEUTICALS · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tasimelteon to see how well it helps children and teenagers with insomnia, which is a condition that makes it hard for them to sleep. The trial is looking for boys and girls aged between 2 and 17 years who have been diagnosed with insomnia. To participate, they need to be able to give their consent or have a legal guardian who can, and their sleep issues shouldn't be caused by other medications.

Participants in this study will take either tasimelteon or a placebo (a pill that looks the same but has no active medication) daily for a certain period. The study is designed to find out if tasimelteon is safe and effective for treating insomnia in children. It’s important to know that children who have certain health issues, like liver problems or those who are pregnant or breastfeeding, cannot join this trial. The study is currently recruiting participants, so if your child is eligible, it could be an opportunity to help improve their sleep.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.