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New sleep pill shows promise for teen insomnia in early trial

NCT ID NCT05423717

Symptom relief Sponsor: Idorsia Pharmaceuticals Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested daridorexant, a sleep medication, in 166 teenagers aged 10 to 17 with chronic insomnia. Participants took one of three doses of the drug or a placebo each evening. Researchers measured changes in total sleep time using overnight sleep tests and monitored safety. The goal was to find the right dose and see if the drug helps teens sleep better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
daridorexant
What this could lead to
If successful, daridorexant could become a new treatment option for teenagers with insomnia, helping them fall asleep and stay asleep longer.
What could go wrong
This is a phase 2 trial with only 166 participants, so results may not apply to all teens. The drug may cause side effects or not work better than placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

166 people

The number who actually took part.

Started

Sep 2022

Finished

Feb 2026

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

10 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: * Signed and dated informed consent form (ICF) from the caregiver, i.e., parent/legal guardian prior to any study mandated procedure, or as per local regulation. * Written assent must be obtained from subjects of the appropriate age who can give assent, as determined by the caregiver and local regulation or institutional review boards / independent ethics committees. * Male or female subjects aged ≥ 10 and \< 18 years at the time of signing the ICF. * Chronic insomnia disorder in accordance with International Classification of Sleep Disorders, 3rd edition (ICSD-3) or insomnia disorder in accordance with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria at Screening, as supported by statements from the child and/or the caregiver: 1. Difficulty initiating or maintaining sleep, or early morning awakening with inability to return to sleep, 2. Sleep difficulty has been present for at least 3 months prior to Screening, 3. Sleep difficulty occurs at least 3 nights per week, 4. Persistence of sleep difficulty, despite adequate sleep hygiene or non-pharmacological therapy, 5. The sleep problem occurs despite adequate age appropriate time and opportunity for sleep, 6. The sleep problem is not due to the direct pharmacological effects of any concomitant medication (e.g., amphetamines, selective serotonin reuptake inhibitors) as per investigator judgment, 7. Self-report or caregiver report of poor sleep quality and/or quantity impacting the daytime performance of the subject, * Sleep Disturbance Scale for Children score \> 16 on the Difficulty Initiating or Maintaining Sleep domain at Screening. * Adolescent of Child-Bearing Potential: 1. Negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization. 2. Agreement to undertake urine pregnancy tests during the study, as per the schedule of activities and up to 5 days after study treatment discontinuation. 3. Agreement to use an acceptable effective method of contraception from Screening up to 5 days after study treatment discontinuation. * Inclusion criteria applicable only to a subset of children with insomnia and comorbid neurodevelopmental disorder (NDD): Must have a documented history of NDD (including autism spectrum disorder or attention deficit hyperactivity disorder) according to DSM-5 criteria, as confirmed by review of medical records, at Screening. Use of central nervous system (CNS) stimulants is allowed if started at least 4 weeks prior to Screening, is stable, and is expected to remain stable during the study until End-of-Treatment. CNS stimulants are recommended to be taken in the morning. Exclusion Criteria: * Body weight \< 25 kg. * Daytime napping ≥ 1 h per day on at least 3 weekdays per week during the 3 months prior to Screening. * Any lifetime history of sleep-related breathing disorders such as obstructive sleep apnea, based on the subject's medical records. Note: a subject whose breathing disorder has been treated by tonsillectomy/ adenoidectomy remains eligible. * Any other diagnosed sleep-wake disorder as defined in DSM-5 or ICSD-3 (e.g., restless legs syndrome, circadian rhythm sleep wake disorder, parasomnias, narcolepsy) at Screening. * Any of the following conditions related to suicidality: 1. Any suicidal ideation with intent, with or without a plan at Screening, i.e., answering "Yes" to questions 4 or 5 on the suicidal ideation section of the lifetime (Visit 1) and visit (Visit 2) version of the Columbia Suicide Severity Rating Scale© (C-SSRS©). Participants who answer "yes" to any of these questions must be referred to the investigator for follow-up evaluation. 2. History of suicide attempt on the suicidal behavior section of the lifetime version of the C-SSRS© at Visit 1. * Any acute or unstable significant medical condition (e.g., seizure disorder, bipolar disorder, schizophrenia), hematology/biochemistry test results, and/or electrocardiogram results deviating from the normal ranges to a clinically relevant extent that would preclude participation in the study or could prevent the subject from complying with study requirements, as per investigator judgement. * Cognitive behavior therapy for any indication is allowed only if it has been started at least 1 month prior to Visit 2 and is kept stable throughout the study.

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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

Contacts and locations

Locations

  • Advanced Sleep Research Berlin GmbH

    Berlin, 10117, Germany

  • Banner - University Medical Center Tucson

    Tucson, Arizona, 85724, United States

  • Bogan Sleep Consultants, LLC

    Columbia, South Carolina, 29201, United States

  • Charité -Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • Clinical Research Institute

    Stockbridge, Georgia, 30281, United States

  • D&H National Research Centers, Inc.

    Miami, Florida, 33155, United States

  • Encore Medical Research of Weston

    Weston, Florida, 33331, United States

  • Florida Pediatric Research Institute

    Winter Park, Florida, 32789, United States

  • HM Puerta del Sur, Unidad del Sueño

    Móstoles, 28938, Spain

  • Hope Research Network

    Miami, Florida, 33166, United States

  • Hospital Quironsalud Valencia - Sleep Unit

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Araba

    Vitoria-Gasteiz, 01004, Spain

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • IRCCS Ospedale Bellaria

    Bologna, 40139, Italy

  • Institute Giannina Gaslini

    Genova, 16147, Italy

  • MC Inspiro

    Sofia, 1784, Bulgaria

  • MC Kalimat

    Sofia, 1680, Bulgaria

  • MC ReSpiro Ltd.

    Razgrad, 7200, Bulgaria

  • MC Sanamedik Ltd.

    Varna, 9000, Bulgaria

  • MC Sun I Zdrave ("Sleep and health") Ltd.

    Sofia, 1618, Bulgaria

  • MC Zdrave 1 Ltd.

    Kozloduy, 3320, Bulgaria

  • MHAT "Heart and Brain" (SJSC)

    Pleven, 508, Bulgaria

  • Meyer Children's Hospital

    Florence, 50139, Italy

  • National Clinical Research, Inc

    Richmond, Virginia, 23294, United States

  • NeuroTrials Research, Inc.

    Atlanta, Georgia, 30328, United States

  • Ospedale Regionale di Lugano Civico - Neurocentro della Svizzera Italiana, Sleep Medicine Unit

    Lugano, 6900, Switzerland

  • Preferred Research Partners, Inc.

    Little Rock, Arkansas, 72211, United States

  • ProSomno

    München, 80333, Germany

  • SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

    Schwerin, 19053, Germany

  • Teradan Clinical Trials

    Brandon, Florida, 33511, United States

  • University Hospital (UMHAT) Sveti Georgi

    Plovdiv, 4001, Bulgaria

  • University of South Florida - Tampa General Hospital (TGH)

    Tampa, Florida, 33606, United States

  • Universitäts-Kinderspital beider Basel (UKBB)

    Basel, 4031, Switzerland

  • Vestische Caritas-Kliniken GmbH, Vestische Kinder- und Jugendklinik Datteln

    Datteln, 45711, Germany

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