Insomnia DisorderPhase 3NCT03545191

Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder

A Phase 3 study testing Daridorexant 25 mg and Daridorexant 50 mg in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 81 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia Disorder
What is being tested?: 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: 930 participants
Where: 81 sitesin 10 countries
Study dates: 4 Jun 2018to 25 Feb 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent prior to any study-mandated procedure;
Male or female aged ≥ 18 years;
Insomnia disorder according to DSM-5 criteria;
Insomnia Severity Index score ≥ 15;
Insufficient sleep quantity as collected subjectively in the sleep diary;
Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.

Who cannot join

Body mass index below 18.5 or above 40.0 kg/m2;
Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea;
Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
Mini Mental State Examination (MMSE) score < 25 in subjects ≥ 50 years;

Show all 9Show fewer

For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Trial locations and contacts

81 sites in 10 countries.

Country

City, postcode or hospital

81 sites in 10 countries

United States36 sites

Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Inquest Clinical Research
Baytown, Texas, 77521
Pulmonary Associates of the Southeast/WCR
Birmingham, Alabama, 35243
PAB Clinical Research
Brandon, Florida, 33511
Helene Emsellem, MD
Chevy Chase, Maryland, 20815
CTI Clinical Research Center
Cincinnati, Ohio, 45212
St. Francis Sleep Allergy and Lung Institute
Clearwater, Florida, 33765
Bogan Sleep Consulting, LLC
Columbia, South Carolina, 29201
Innovative Clinical Research, Inc.
Hialeah, Florida, 33012
Research Centers of America
Hollywood, Florida, 33024
Research Carolina of Huntersville
Huntersville, North Carolina, 28078
Marvel Clinical Research
Huntington Beach, California, 92647
Tri-State Mountain Neurology
Johnson City, Tennessee, 37604
Barrett Clinic
La Vista, Nebraska, 68128
Canvas Clinical Research, LLC
Lake Worth, Florida, 33467
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
BTC of Lincoln
Lincoln, Rhode Island, 02865
Preferred Research Partners, Inc
Little Rock, Arkansas, 72211
Long Beach Clinical Trials
Long Beach, California, 90806
Kentucky Research Group
Louisville, Kentucky, 40218
BioMed Research Institute
Miami, Florida, 33126
LaPorte County Institute for Clinical Research
Michigan City, Indiana, 46360
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Coastal Carolina Healthcare
New Bern, North Carolina, 28562
Clinilabs NYC
New York, New York, 10019
Infinity Medical Research, Inc.
North Dartmouth, Massachusetts, 02747
Aspen Clinical Research
Orem, Utah, 84058
Pulmonary Associates of Richmond
Richmond, Virginia, 23225
Woodland Research Northwest
Rogers, Arkansas, 72758
Oregon Center for Clinical Investigations,Inc
Salem, Oregon, 97301
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Artemis Institute for Clinical Research
San Diego, California, 92103
Swedish Medical Center
Seattle, Washington, 98122
Sleep Disorders Centers of the Mid-Atlantic
Vienna, Virginia, 22182
Omega Medical Research
Warwick, Rhode Island, 02886
Clinical Site Partners, LLC
Winter Park, Florida, 32789

Other trials in United States

Germany11 sites

St Hedwig-Krankenhaus, Klinik für Schlaf- und Chronomedizin
Berlin, 10115
emovis GmbH
Berlin, 10629
Synexus Berlin Research Centre
Berlin, 12627
Clinical Trial Center North GmbH & Co. KG
Hamburg, 20251
Klinische Forschung Hamburg GmbH
Hamburg, 20253
Klinische Forschung Karlsruhe GmbH
Karlsruhe, 76137
Studienzentrum Wilhelmshöhe GmbH
Kassel, 34131
Synexus Leipzig Research Centre
Leipzig, 4103
Klinikum Rechts der lsar TU München Dept. of Psychiatry and Psychotherapy
München, 81675
Kinische Forschung Schwerin GmbH
Schwerin, 19055
ZMS Zentrum für medizinische Studien GmbH
Warendorf, 48231

Other trials in Germany

Spain8 sites

Centro Médico Teknon - Medicina del Sueño
Barcelona, 8017
Hospital de La Santa Creu I Sant Pau
Barcelona, 8025
Hospital Universitari Vall d'Hebron - Neurophisiology Deparment - Sleep Unit
Barcelona, 8035
Hospital General de Castellon
Castellon, 12004
Instituto de Investigaciones del Sueno
Madrid, 28036
San Carlos University Hospital - Servicio de Neurofisiología Clínica
Madrid, 28040
Hospital Universitario Araba - Unidad Funcional de Trastornos del Sueño
Vitoria-Gasteiz, 1004
Hospital MAZ - Neurophisiology and Sleep Department
Zaragoza, 50015

Other trials in Spain

Australia7 sites

Respiratory Clinical Trials
Adelaide, 5065
Genesis Sleep Care Queensland
Auchenflower, 4066
Melbourne Sleep Disorders Centre
East Melbourne, 3002
The Woolcock Institute of Medical Research
Glebe, 2037
Royal Melbourne Hospital, Department of Respiratory Medicine
Parkville, 3052
Gold Coast University Hospital, Respiratory Medicine and Sleep Services
Southport, 4215
Westmead Hospital, Department of Respiratory and Sleep Medicine
Westmead, 2145

Other trials in Australia

Switzerland5 sites

KSM Bad Zurzach, Klinik für Schlafmedizin
Bad Zurzach, 5330
Universitäre Psychiatrische Kliniken Basel (Upk)
Basel, 4002
Universitätsklinik für Neurologie, Inselspital Bern, Schlaf-Wach-Epilepsie-Zentrum
Bern, 3010
Zentrum für Schlafmedizin Zürcher Oberland, Zürcher RehaZentrum Wald
Wald, 8636
Zentrum für Schlafmedizin GZO AG Spital Wetzikon
Wetzikon, 8620

Other trials in Switzerland

Canada4 sites

Tri-Hospital Sleep Laboratory West
Mississauga, L5B 4M4
CRIUSMQ- CIUSSSCN, CETS (clinique du sommeil)
Québec, G1J 2G2
MedSleep
Toronto, M4P 1P2
Jodha Tishon Inc.
Toronto, M5G1N8

Other trials in Canada

Italy4 sites

Ospedale San Raffaele - Centro per i Disturbi del Sonno San Raffaele - Ville-Turro - Pallazzina E
Milan, 20127
IRCCS FONDAZIONE Istituto Neurologico Nazionale "Casimiro Mondino" - Centro di Ricerca Interdipartimentale per la SSclerosi Multipla (CRISM) -
Pavia, 27100
Azienda Ospedaliero Universitaria Pisana - Ospedale S. Chiara - Centro di Medicina del Sonno - Clinica Neuroligica - Dipartimento de Neuroscienze
Pisa, 56126
AOU Citta della Salute e della Scienza - Molinette - SSD Medicina del Sonno
Torino, 10146

Other trials in Italy

Poland3 sites

PI-House - Centrum Badań Klinicznych
Gdansk, 80-546
Ośrodek Medycyny Study Nurseu Instytutu Psychiatrii i Neurologii (Sleep Disorders Center)
Warsaw, 02-957
EMC Instytut Medyczny SA, Przychodnia przy Łowieckiej
Wroclaw, 50220

Other trials in Poland

Serbia2 sites

General Hospital Bel Medic, Center for Sleep disorders
Belgrade, 11000
Medigroup - Health Center Dr Ristic (MediGroup Dom zdravlja "Dr Ristic") - Neurology Department
New Belgrade, 11070

Other trials in Serbia

Denmark1 site

Scan Sleep Specialists
Copenhagen, 1053

Other trials in Denmark

About this study

Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder

Conditions: Insomnia Disorder
Being tested: 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 25 mgDrug
Daridorexant will be administered as tablets, orally, once daily in the evening.
Daridorexant 50 mgDrug
Daridorexant will be administered as tablets, orally, once daily in the evening.
PlaceboOther
Matching placebo will be administered as tablets, orally, once daily in the evening.

Study groups in NCT03545191
Study group	Role	What they receive
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: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Measured: From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Measured: From baseline to Month 3 (i.e. for up to 3 months)
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Measured: From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Measured: From baseline to Month 3 (i.e. for up to 3 months)

Secondary outcomes (4)

Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)
"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Measured: From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)
"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.
Measured: From baseline to Month 3 (i.e. for up to 3 months)
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Measured: From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Measured: From baseline to Month 3 (i.e. for up to 3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 201825 Feb 2020

First posted4 Jun 2018
Study start4 Jun 2018
Primary completion25 Jan 2020
Study completion25 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Insomnia DisorderStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 930 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03545191
Sponsor's protocol ID: ID-078A301
Status last verified: Mar 2022
First submitted: 22 May 2018
Last updated: 25 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.
PubMed 33131027
Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1.
PubMed 35065036
Schaedel Z, Bakker TR, Bassetti C, Briasoulis O, Cassel P, Pain S, Palacios S, Palmay C, Silvestri R, Stute P, Tremollieres F, Bertisch SM. Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial. Maturitas. 2026 Mar;206:108821. doi: 10.1016/j.maturitas.2025.108821. Epub 2025 Dec 23.
PubMed 41506007
Pathmanathan J, Little D, Sadeghi K, Di Marco T, Kleinschmidt D, Nerrie J, Tjiptarto N, Arslan A, Hubbard J, Olivieri A, Puryear CB, Brandon Westover M, Donoghue J. The Insomnia EEG Score: a new tool for the classification of people with poor sleep. Sleep. 2026 Apr 16;49(4):zsaf353. doi: 10.1093/sleep/zsaf353.
PubMed 41217192
Lettieri CJ, Briasoulis O, Leger D, Luyet PP, Pepin JL, Quan SF, Raphelson J, Saskin P, Malhotra A. The Effects of Daridorexant on Patients With Comorbid Insomnia Disorder and Untreated Mild Obstructive Sleep Apnoea: A Post Hoc Subgroup Analysis of a Phase 3, Randomised Clinical Trial. J Sleep Res. 2026 Apr;35(2):e70135. doi: 10.1111/jsr.70135. Epub 2025 Jul 14.
PubMed 40660750
Dauvilliers Y, Braunstein G, Zammit G, Olivieri A, Luyet PP. Effect of daridorexant on nighttime wakefulness and next-morning sleepiness: assessing the transition from night to day in insomnia disorder. Sleep Med. 2025 Jul;131:106523. doi: 10.1016/j.sleep.2025.106523. Epub 2025 Apr 17.
PubMed 40288253
Di Marco T, Djonlagic I, Dauvilliers Y, Sadeghi K, Little D, Datta AN, Hubbard J, Hajak G, Krystal A, Olivieri A, Parrino L, Puryear CB, Zammit G, Donoghue J, Scammell TE. Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder: a pooled post hoc analysis of two randomized phase 3 clinical studies. Sleep. 2024 Nov 8;47(11):zsae098. doi: 10.1093/sleep/zsae098.
PubMed 38644625
Phillips-Beyer A, Kawata AK, Kleinman L, Seboek Kinter D, Flamion B. Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials. Pharmaceut Med. 2024 Mar;38(2):133-144. doi: 10.1007/s40290-023-00512-9. Epub 2024 Feb 1.
PubMed 38302765
Citrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.
PubMed 37796657
Dutta S, Singhal S, Shah R, Charan J, Dhingra S, Haque M. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7.
PubMed 37526060
Di Marco T, Scammell TE, Meinel M, Seboek Kinter D, Datta AN, Zammit G, Dauvilliers Y. Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. CNS Drugs. 2023 Jul;37(7):639-653. doi: 10.1007/s40263-023-01020-9. Epub 2023 Jul 21.
PubMed 37477771
Phillips-Beyer A, Kawata AK, Kleinman L, Kinter DS. Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant. Pharmaceut Med. 2023 Jul;37(4):291-303. doi: 10.1007/s40290-023-00484-w. Epub 2023 Jun 7.
PubMed 37286927
Fietze I, Bassetti CLA, Mayleben DW, Pain S, Seboek Kinter D, McCall WV. Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial. Drugs Aging. 2022 Oct;39(10):795-810. doi: 10.1007/s40266-022-00977-4. Epub 2022 Sep 13.
PubMed 36098936
Heidenreich S, Ross M, Chua GN, Seboek Kinter D, Phillips-Beyer A. Preferences of patients for benefits and risks of insomnia medications using data elicited during two phase III clinical trials. Sleep. 2022 Nov 9;45(11):zsac204. doi: 10.1093/sleep/zsac204.
PubMed 36054921

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder

All Insomnia Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2022. 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 Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder
ClinicalTrials.gov ID: NCT03545191
Acronym / sponsor ID: ID-078A301
Conditions: Insomnia Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 930 participants (actual)
Lead sponsor: Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
Study start: 4 Jun 2018 (actual)
Primary completion: 25 Jan 2020 (actual)
Study completion: 25 Feb 2020 (actual)
First posted: 4 Jun 2018 (actual)
Results: Posted 25 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Daridorexant 25 mg	Experimental	Drug: Daridorexant 25 mg
Daridorexant 50 mg	Experimental	Drug: Daridorexant 50 mg
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Signed informed consent prior to any study-mandated procedure;
Male or female aged ≥ 18 years;
Insomnia disorder according to DSM-5 criteria;
Insomnia Severity Index score ≥ 15;
Insufficient sleep quantity as collected subjectively in the sleep diary;

Key exclusion criteria (9 listed)

Body mass index below 18.5 or above 40.0 kg/m2;
Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/ hypopnea;
Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;

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 25 mgDaridorexant will be administered as tablets, orally, once daily in the evening.	Drug	Daridorexant 25 mg
Daridorexant 50 mgDaridorexant will be administered as tablets, orally, once daily in the evening.	Drug	Daridorexant 50 mg
PlaceboMatching placebo will be administered as tablets, orally, once daily in the evening.	Other	Placebo

Primary outcome

Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
Time frame: From baseline to Month 1 (i.e. for up to 1 month)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)
Time frame: From baseline to Month 3 (i.e. for up to 3 months)
"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.
Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)
Time frame: From baseline to Month 1 (i.e. for up to 1 month)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.
Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)
Time frame: From baseline to Month 3 (i.e. for up to 3 months)
"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.

4 secondary outcomes

Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)
Time frame: From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)
Time frame: From baseline to Month 3 (i.e. for up to 3 months)
Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score
Time frame: From baseline to Month 1 (i.e. for up to 1 month)
Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score
Time frame: From baseline to Month 3 (i.e. for up to 3 months)

Results and safety

Results posted to the registry on 25 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daridorexant 25 mg	310	288
Daridorexant 50 mg	310	285
Placebo	310	280

Primary outcome: Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)

Time frame: From baseline to Month 1 (i.e. for up to 1 month). Least squares mean (95% Confidence Interval). Unit: minutes

Measure	Daridorexant 25 mg n = 310	Daridorexant 50 mg n = 310	Placebo n = 310
Value	-18.40 (-22.126 to -14.674)	-28.98 (-32.668 to -25.299)	-6.20 (-9.928 to -2.475)

Daridorexant 25 mg vs Placebo: LS mean difference to placebo: -12.20 (95% CI -17.435 to -6.961), p <0.0001, Mixed Models Analysis
Daridorexant 50 mg vs Placebo: LS mean difference to placebo: -22.78 (95% CI -27.996 to -17.567), p <0.0001, Mixed Models Analysis

Primary outcome: Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)

Time frame: From baseline to Month 3 (i.e. for up to 3 months). Least squares mean (95% Confidence Interval). Unit: minutes

Measure	Daridorexant 25 mg n = 310	Daridorexant 50 mg n = 310	Placebo n = 310
Value	-22.97 (-26.955 to -18.988)	-29.41 (-33.399 to -25.427)	-11.11 (-15.131 to -7.088)

Daridorexant 25 mg vs Placebo: LS mean difference to placebo: -11.86 (95% CI -17.494 to -6.23), p <0.0001, Mixed Models Analysis
Daridorexant 50 mg vs Placebo: LS mean difference to placebo: -18.3 (95% CI -23.945 to -12.661), p <0.0001, Mixed Models Analysis

Primary outcome: Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)

Time frame: From baseline to Month 1 (i.e. for up to 1 month). Least squares mean (95% Confidence Interval). Unit: minutes

Measure	Daridorexant 25 mg n = 310	Daridorexant 50 mg n = 310	Placebo n = 310
Value	-28.17 (-31.509 to -24.827)	-31.20 (-34.506 to -27.896)	-19.85 (-23.177 to -16.515)

Daridorexant 25 mg vs Placebo: LS mean difference to placebo: -8.32 (95% CI -13.014 to -3.629), p = 0.0005, Mixed Models Analysis
Daridorexant 50 mg vs Placebo: LS mean difference to placebo: -11.35 (95% CI -16.022 to -6.687), p <0.0001, Mixed Models Analysis

Primary outcome: Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)

Time frame: From baseline to Month 3 (i.e. for up to 3 months). Least squares mean (95% Confidence Interval). Unit: minutes

Measure	Daridorexant 25 mg n = 310	Daridorexant 50 mg n = 310	Placebo n = 310
Value	-30.73 (-34.037 to -27.417)	-34.80 (-38.118 to -31.490)	-23.13 (-26.464 to -19.803)

Daridorexant 25 mg vs Placebo: LS mean difference to placebo: -7.59 (95% CI -12.265 to -2.923), p = 0.0015, Mixed Models Analysis
Daridorexant 50 mg vs Placebo: LS mean difference to placebo: -11.67 (95% CI -16.348 to -6.994), p <0.0001, Mixed Models Analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daridorexant 25 mg	2 of 310 (0.6%)	44 of 310 (14.2%)	1 of 310
Daridorexant 50 mg	3 of 308 (1%)	41 of 308 (13.3%)	0 of 308
Placebo	7 of 309 (2.3%)	35 of 309 (11.3%)	0 of 309

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33131027Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.
Results publication: PubMed 35065036Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1.
Derived from this study: PubMed 41506007Schaedel Z, Bakker TR, Bassetti C, Briasoulis O, Cassel P, Pain S, Palacios S, Palmay C, Silvestri R, Stute P, Tremollieres F, Bertisch SM. Efficacy and safety of daridorexant for the treatment of insomnia disorder in women of menopausal transition age: Insights from a randomized controlled trial. Maturitas. 2026 Mar;206:108821. doi: 10.1016/j.maturitas.2025.108821. Epub 2025 Dec 23.
Derived from this study: PubMed 41217192Pathmanathan J, Little D, Sadeghi K, Di Marco T, Kleinschmidt D, Nerrie J, Tjiptarto N, Arslan A, Hubbard J, Olivieri A, Puryear CB, Brandon Westover M, Donoghue J. The Insomnia EEG Score: a new tool for the classification of people with poor sleep. Sleep. 2026 Apr 16;49(4):zsaf353. doi: 10.1093/sleep/zsaf353.
Derived from this study: PubMed 40660750Lettieri CJ, Briasoulis O, Leger D, Luyet PP, Pepin JL, Quan SF, Raphelson J, Saskin P, Malhotra A. The Effects of Daridorexant on Patients With Comorbid Insomnia Disorder and Untreated Mild Obstructive Sleep Apnoea: A Post Hoc Subgroup Analysis of a Phase 3, Randomised Clinical Trial. J Sleep Res. 2026 Apr;35(2):e70135. doi: 10.1111/jsr.70135. Epub 2025 Jul 14.
Derived from this study: PubMed 40288253Dauvilliers Y, Braunstein G, Zammit G, Olivieri A, Luyet PP. Effect of daridorexant on nighttime wakefulness and next-morning sleepiness: assessing the transition from night to day in insomnia disorder. Sleep Med. 2025 Jul;131:106523. doi: 10.1016/j.sleep.2025.106523. Epub 2025 Apr 17.
Derived from this study: PubMed 38644625Di Marco T, Djonlagic I, Dauvilliers Y, Sadeghi K, Little D, Datta AN, Hubbard J, Hajak G, Krystal A, Olivieri A, Parrino L, Puryear CB, Zammit G, Donoghue J, Scammell TE. Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder: a pooled post hoc analysis of two randomized phase 3 clinical studies. Sleep. 2024 Nov 8;47(11):zsae098. doi: 10.1093/sleep/zsae098.
Derived from this study: PubMed 38302765Phillips-Beyer A, Kawata AK, Kleinman L, Seboek Kinter D, Flamion B. Meaningful Within-Patient Change in Subjective Total Sleep Time in Patients with Insomnia Disorder: An Analysis of the Sleep Diary Questionnaire Using Data from Open-Label and Phase III Clinical Trials. Pharmaceut Med. 2024 Mar;38(2):133-144. doi: 10.1007/s40290-023-00512-9. Epub 2024 Feb 1.
Derived from this study: PubMed 37796657Citrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.
Derived from this study: PubMed 37526060Dutta S, Singhal S, Shah R, Charan J, Dhingra S, Haque M. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7.
Derived from this study: PubMed 37477771Di Marco T, Scammell TE, Meinel M, Seboek Kinter D, Datta AN, Zammit G, Dauvilliers Y. Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. CNS Drugs. 2023 Jul;37(7):639-653. doi: 10.1007/s40263-023-01020-9. Epub 2023 Jul 21.
Derived from this study: PubMed 37286927Phillips-Beyer A, Kawata AK, Kleinman L, Kinter DS. Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant. Pharmaceut Med. 2023 Jul;37(4):291-303. doi: 10.1007/s40290-023-00484-w. Epub 2023 Jun 7.
Individual participant dataSharing planned: No

Related trials for Insomnia Disorder

Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder

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.

81 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daridorexant 25 mg and Daridorexant 50 mg in people with Insomnia Disorder, run by Idorsia Pharmaceuticals Ltd. at 81 sites in 10 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 6 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Germany, Spain, Australia, Switzerland and 5 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance) (time frame: From baseline to Month 1 (i.e. for up to 1 month)). The study lists 4 primary outcomes in all. 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 NCT03545191, which also lists 14 linked publications.

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 25 Mar 2022.