New sleep pill shows promise for teen insomnia in early trial

NCT ID NCT05423717

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

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.

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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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