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Can a pill help kids with insomnia sleep better?

NCT ID NCT06953869

Symptom relief Sponsor: Vanda Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily dose of tasimelteon helps children aged 2 to 17 with insomnia fall asleep faster and sleep better. About 420 participants will receive either the drug or a placebo. The goal is to improve sleep and daytime functioning without serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vanda Investigational Site

    RECRUITING

    Dothan, Alabama, 36303, United States

  • Vanda Investigational Site

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • Vanda Investigational Site

    RECRUITING

    Irvine, California, 92614, United States

  • Vanda Investigational Site

    RECRUITING

    Miami, Florida, 33155, United States

  • Vanda Investigational Site

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Vanda Investigational Site

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Vanda Investigational Site

    RECRUITING

    Snellville, Georgia, 30078, United States

  • Vanda Investigational Site

    RECRUITING

    Stockbridge, Georgia, 30281, United States

  • Vanda Investigational Site

    RECRUITING

    Naperville, Illinois, 60563, United States

  • Vanda Investigational Site

    RECRUITING

    Worcester, Massachusetts, 01608, United States

  • Vanda Investigational Site

    RECRUITING

    Great Falls, Montana, 59405, United States

  • Vanda Investigational Site

    ACTIVE_NOT_RECRUITING

    Lincoln, Nebraska, 68526, United States

  • Vanda Investigational Site

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Vanda Investigational Site

    RECRUITING

    Cleveland, Ohio, 11100, United States

  • Vanda Investigational Site

    RECRUITING

    Columbia, South Carolina, 29201, United States

  • Vanda Investigational Site

    RECRUITING

    Myrtle Beach, South Carolina, 29582, United States

  • Vanda Investigational Site

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Vanda Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Vanda Investigational Site

    RECRUITING

    Plano, Texas, 75075, United States

  • Vanda Investigational Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Vanda Investigational Site

    RECRUITING

    San Antonio, Texas, 78249, United States

  • Vanda Investigational Site

    RECRUITING

    Berlin, 10117, Germany

  • Vanda Investigational Site

    RECRUITING

    Leipzig, 04177, Germany

  • Vanda Investigational Site

    RECRUITING

    Bydgoszcz, 85-092, Poland

  • Vanda Investigational Site

    RECRUITING

    Gdansk, 80-546, Poland

  • Vanda Investigational Site

    RECRUITING

    Krakow, 30-721, Poland

  • Vanda Investigational Site

    RECRUITING

    Poznan, 60-848, Poland

  • Vanda Investigational Site

    RECRUITING

    Wroclaw, 50-414, Poland

  • Vanda Investigational Site

    RECRUITING

    Great Yarmouth, NR31 6LA, United Kingdom

  • Vanda Investigational Site

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • Vanda Investigational Site

    RECRUITING

    Liverpool, L12 2AP, United Kingdom

  • Vanda Investigational Site

    RECRUITING

    London, E1 1FR, United Kingdom

  • Vanda Investigational Site

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Vanda Investigational Site

    RECRUITING

    London, SE6 4LF, United Kingdom

  • Vanda Investigational Site

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

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