InsomniaPhase 2NCT05423717
Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
A Phase 2 study testing Daridorexant 10 mg, Daridorexant 25 mg and Daridorexant 50 mg in people with Insomnia, run by Idorsia Pharmaceuticals Ltd. at 35 sites in 6 countries.
Trial summary
This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Daridorexant 10 mg, Daridorexant 25 mg and Daridorexant 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 35 sitesin 6 countries
- Study dates
- 6 Sep 2022to 5 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- Difficulty initiating or maintaining sleep, or early morning awakening with inability to return to sleep,
- Sleep difficulty has been present for at least 3 months prior to Screening,
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- Sleep difficulty occurs at least 3 nights per week,
- Persistence of sleep difficulty, despite adequate sleep hygiene or non-pharmacological therapy,
- The sleep problem occurs despite adequate age appropriate time and opportunity for sleep,
- 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,
- 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:
- Negative serum pregnancy test at Screening and a negative urine pregnancy test at Randomization.
- Agreement to undertake urine pregnancy tests during the study, as per the schedule of activities and up to 5 days after study treatment discontinuation.
- 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.
Who cannot join
- 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:
- 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.
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- 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.
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
United States12 sites
NeuroTrials Research, Inc.
Atlanta, Georgia, 30328
Teradan Clinical Trials
Brandon, Florida, 33511
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
D&H National Research Centers, Inc.
Miami, Florida, 33155
Hope Research Network
Miami, Florida, 33166
National Clinical Research, Inc
Richmond, Virginia, 23294
Clinical Research Institute
Stockbridge, Georgia, 30281
University of South Florida - Tampa General Hospital (TGH)
Tampa, Florida, 33606
Banner - University Medical Center Tucson
Tucson, Arizona, 85724
Encore Medical Research of Weston
Weston, Florida, 33331
Florida Pediatric Research Institute
Winter Park, Florida, 32789
Bulgaria8 sites
MC Zdrave 1 Ltd.
Kozloduy, 3320
MHAT "Heart and Brain" (SJSC)
Pleven, 508
University Hospital (UMHAT) Sveti Georgi
Plovdiv, 4001
MC ReSpiro Ltd.
Razgrad, 7200
MC Sun I Zdrave ("Sleep and health") Ltd.
Sofia, 1618
MC Kalimat
Sofia, 1680
MC Inspiro
Sofia, 1784
MC Sanamedik Ltd.
Varna, 9000
Germany5 sites
Advanced Sleep Research Berlin GmbH
Berlin, 10117
Charité -Universitätsmedizin Berlin
Berlin, 12203
Vestische Caritas-Kliniken GmbH, Vestische Kinder- und Jugendklinik Datteln
Datteln, 45711
ProSomno
München, 80333
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, 19053
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
HM Puerta del Sur, Unidad del Sueño
Móstoles, 28938
Hospital Quironsalud Valencia - Sleep Unit
Valencia, 46010
Hospital Universitario Araba
Vitoria-Gasteiz, 01004
Italy3 sites
IRCCS Ospedale Bellaria
Bologna, 40139
Meyer Children's Hospital
Florence, 50139
Institute Giannina Gaslini
Genova, 16147
Switzerland2 sites
Universitäts-Kinderspital beider Basel (UKBB)
Basel, 4031
Ospedale Regionale di Lugano Civico - Neurocentro della Svizzera Italiana, Sleep Medicine Unit
Lugano, 6900
About this study
Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography, Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Multiple-dose Oral Administration of Daridorexant in Pediatric Subjects Aged 10 to < 18 Years With Insomnia Disorder
This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder.
- Conditions
- Insomnia
- Being tested
- Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg, Placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daridorexant 10 mgDrug
Daridorexant will be taken orally, once daily in the evening during the treatment period.
Daridorexant 25 mgDrug
Daridorexant will be taken orally, once daily in the evening during the treatment period.
Daridorexant 50 mgDrug
Daridorexant will be taken orally, once daily in the evening during the treatment period.
PlaceboDrug
Placebo will be taken orally, once daily in the evening during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant 10 mg | Experimental | Not described Receives: Drug: Daridorexant 10 mg |
| Daridorexant 25 mg | Experimental | Not described Receives: Drug: Daridorexant 25 mg |
| Daridorexant 50 mg | Experimental | Not described Receives: Drug: Daridorexant 50 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG).
Baseline is defined as the mean of the 2 PSG nights during the screening period.
Measured: PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total duration: 3 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start6 Sep 2022
- Primary completion12 Jan 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423717
- Sponsor's protocol ID
- ID-078A205
- Other IDs
- 2024-513885-20-00
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2022
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coloma P, Coury D, Wernette S, Beevers V, Dubois C, Di Marco T, Dursun OT, Bruni O. Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial. BMJ Open. 2026 Apr 6;16(4):e099888. doi: 10.1136/bmjopen-2025-099888.
PubMed 41942161
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography, Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Multiple-dose Oral Administration of Daridorexant in Pediatric Subjects Aged 10 to < 18 Years With Insomnia Disorder
- ClinicalTrials.gov ID
- NCT05423717
- Acronym / sponsor ID
- ID-078A205
- Conditions
- Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Daridorexant 10 mg | Experimental | Drug: Daridorexant 10 mg |
| Daridorexant 25 mg | Experimental | Drug: Daridorexant 25 mg |
| Daridorexant 50 mg | Experimental | Drug: Daridorexant 50 mg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- 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:
- Sleep Disturbance Scale for Children score > 16 on the Difficulty Initiating or Maintaining Sleep domain at Screening.
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daridorexant 10 mgDaridorexant will be taken orally, once daily in the evening during the treatment period. | Drug | Daridorexant 10 mg |
| Daridorexant 25 mgDaridorexant will be taken orally, once daily in the evening during the treatment period. | Drug | Daridorexant 25 mg |
| Daridorexant 50 mgDaridorexant will be taken orally, once daily in the evening during the treatment period. | Drug | Daridorexant 50 mg |
| PlaceboPlacebo will be taken orally, once daily in the evening during the treatment period. | Drug | Placebo |
Primary outcome
Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG).
Time frame: PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total duration: 3 days).
Baseline is defined as the mean of the 2 PSG nights during the screening period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 41942161Coloma P, Coury D, Wernette S, Beevers V, Dubois C, Di Marco T, Dursun OT, Bruni O. Daridorexant in children and adolescents with insomnia disorder: study protocol for a multicentre randomised controlled trial. BMJ Open. 2026 Apr 6;16(4):e099888. doi: 10.1136/bmjopen-2025-099888.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daridorexant 10 mg, Daridorexant 25 mg and Daridorexant 50 mg in people with Insomnia, run by Idorsia Pharmaceuticals Ltd. at 35 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Bulgaria, Germany, Spain, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Day 1 in Total Sleep Time (TST) as measured by polysomnography (PSG). (time frame: PSG will be performed on 2 nights during the screening period and on Day 1 of the treatment period (total duration: 3 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05423717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.