Insomnia DisorderPhase 4NCT05597020

A Study to Find Out if Daridorexant is Safe and Efficacious in Patients With Insomnia and Comorbid Nocturia

A Phase 4 study testing Daridorexant in people with Insomnia Disorder and Nocturia, run by Idorsia Pharmaceuticals Ltd. at 16 sites in 3 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

A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Insomnia Disorder, Nocturia
What is being tested?: Daridorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 16 sitesin 3 countries
Study dates: 16 Feb 2023to 18 Apr 2024
Phase: Phase 4
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 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed and dated informed consent form (ICF) prior to any study-mandated procedure.
Male or female subjects ≥ 55 years old at the time of signing the ICF.
Insomnia complaints for at least 3 months prior to Visit 1.
Insomnia Severity Index© (ISI©) score ≥ 13 at Visit 1.
Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjects for at least 1 month prior to Visit 1.
Ability to communicate well with the investigator, to understand the study requirements and judged by the investigator to be alert and oriented to person, place, time, and situation.

Who cannot join

Woman of childbearing potential, pregnant or plans to become pregnant.
Planned travel across ≥ 3 time zones during study.
Life time history of suicidality assessed via Columbia Suicide Severity Rating Scale© (C-SSRS©).
Regular caffeine consumption after 4 pm.
Unable to refrain from smoking during the night.
Known and documented diagnosis of narcolepsy, periodic limb movement disorder, moderate to severe obstructive sleep apnea, restless legs syndrome, circadian rhythm sleep-wake disorder, or rapid eye movement (REM) sleep behavior disorder.

Show all 9Show fewer

Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2 diabetes mellitus, central or nephrogenic diabetes insipidus, and primary/secondary polydipsia.
Known and documented nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction within the last 6 months prior to Visit 1.
Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.

Trial locations and contacts

16 sites in 3 countries.

Country

City, postcode or hospital

16 sites in 3 countries

Spain8 sites

Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital del Mar
Barcelona, 08003
UROCLINICA Barcelona
Barcelona, 08006
Hospital Universitario Puerta del Mar (HUPM)
Cadiz, 11009
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Central de Asturias
Oviedo, 33011
Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, 38320

Other trials in Spain

United States5 sites

Accellacare Research of Cary
Cary, North Carolina, 27518
Quantum Clinical Trials
Miami Beach, Florida, 33140
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Ochsner LSU Health Shreveport-Regional Urology
Shreveport, Louisiana, 71106
Encore Medical Research of Weston
Weston, Florida, 33331

Other trials in United States

Germany3 sites

Praxisklinik am Franziskushospital - Urologisches Zentrum Euregio
Aachen, 52064
ASR Advanced Sleep Research GmBH
Berlin, 10117
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH
Schwerin, 19053

Other trials in Germany

About this study

Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, 2-way Cross-over Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia

A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia

Conditions: Insomnia Disorder, Nocturia
Being tested: Daridorexant, Placebo
Medical subject headings: Sleep Initiation and Maintenance Disorders, Nocturia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DaridorexantDrug
Daridorexant is available as oral film-coated tablets at a strength of 50 mg.
PlaceboDrug
Placebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.

Study groups in NCT05597020
Study group	Role	What they receive
50 mg daridorexant	Experimental	Daridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed. Receives: Drug: Daridorexant
Placebo	Placebo comparator	Matching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed. Receives: Drug: Placebo

What is being measured

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

Change From Baseline to Week 4 in sTST
Subjective total sleep time (sTST) is the total sleep time reported by the subject in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST.
Baseline is the mean value based on the subject's sleep diary entries for sTST on the 7 days preceding randomization.
Week 4 is the mean value based on the subject's sleep diary entries for sTST on study days 23-29 of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).
Measured: From baseline to Week 4 per treatment period.

Timeline

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

16 Feb 202318 Apr 2024

First posted27 Oct 2022
Study start16 Feb 2023
Primary completion12 Apr 2024
Study completion18 Apr 2024

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 (1)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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: This is a multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over post-approval study.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05597020
Sponsor's protocol ID: ID-078A401
Other IDs: 2022-501246-30-00
Status last verified: Apr 2025
First submitted: 25 Oct 2022
Last updated: 18 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Arnaldi D, Bliwise DL, Alpan D, Koochaki P, Meinel M, Olivieri A, Rowles R, Satapathy A, Lederer K. Capturing the Patient Voice: Qualitative Assessment of Daridorexant's Impact on Patients with Insomnia and Comorbid Nocturia from a Randomized, Placebo-Controlled Crossover Trial. Adv Ther. 2026 Oct 6. doi: 10.1007/s12325-026-03803-0. Online ahead of print.
PubMed 42836930

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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, 2-way Cross-over Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia
ClinicalTrials.gov ID: NCT05597020
Acronym / sponsor ID: ID-078A401
Conditions: Insomnia Disorder, Nocturia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
Study start: 16 Feb 2023 (actual)
Primary completion: 12 Apr 2024 (actual)
Study completion: 18 Apr 2024 (actual)
First posted: 27 Oct 2022 (actual)
Results: Posted 18 Apr 2025

Clinical summary

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

A study to find out if daridorexant is safe and efficacious in patients with insomnia and comorbid nocturia

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: This is a multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over post-approval study.

Arm	Type	Receives
50 mg daridorexant	Experimental	Drug: DaridorexantDaridorexant will be taken orally, once daily in the evening within approximately 30 min before going to bed.
Placebo	Placebo comparator	Drug: PlaceboMatching placebo will be taken orally, once daily in the evening within approximately 30 min before going to bed.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Signed and dated informed consent form (ICF) prior to any study-mandated procedure.
Male or female subjects ≥ 55 years old at the time of signing the ICF.
Insomnia complaints for at least 3 months prior to Visit 1.
Insomnia Severity Index© (ISI©) score ≥ 13 at Visit 1.
Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjects for at least 1 month prior to Visit 1.

Key exclusion criteria (9 listed)

Woman of childbearing potential, pregnant or plans to become pregnant.
Planned travel across ≥ 3 time zones during study.
Life time history of suicidality assessed via Columbia Suicide Severity Rating Scale© (C-SSRS©).
Regular caffeine consumption after 4 pm.
Unable to refrain from smoking during the night.

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
DaridorexantDaridorexant is available as oral film-coated tablets at a strength of 50 mg.	Drug	50 mg daridorexant
PlaceboPlacebo matching daridorexant is provided as identical-looking oral tablets, formulated with the same inactive ingredients (excipients) as the active tablets.	Drug	Placebo

Primary outcome

Change From Baseline to Week 4 in sTST
Time frame: From baseline to Week 4 per treatment period.
Subjective total sleep time (sTST) is the total sleep time reported by the subject in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. Baseline is the mean value based on the subject's sleep diary entries for sTST on the 7 days preceding randomization. Week 4 is the mean value based on the subject's sleep diary entries for sTST on study days 23-29 of each treatment period, regardless of premature treatment discontinuations (treatment policy strategy).

Results and safety

Results posted to the registry on 18 Apr 2025, 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 50 mg, Then Placebo	30	30
Placebo, Then Daridorexant 50 mg	30	30

Primary outcome: Change From Baseline to Week 4 in sTST

Time frame: From baseline to Week 4 per treatment period.. Least squares mean (95% Confidence Interval). Unit: minutes

Measure	Daridorexant 50 mg n = 60	Placebo n = 60
Value	56.6 (46.0 to 67.2)	35.7 (25.0 to 46.4)

Daridorexant 50 mg vs Placebo: Least Square mean difference vs placebo: 20.9 (95% CI 8.0 to 33.7), p = 0.002, Mixed Models Analysis

Population analysed: The analysis included all randomized subjects who received at least one dose of study treatment.

Adverse events

Time frame: Treatment-emergent adverse events from the 29-day (± 2 days) treatment periods are reported. Adverse events were considered treatment-emergent if the date of onset or worsening was from the first intake of study treatment up to 5 days after the end of study treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daridorexant 50 mg	0 of 60 (0%)	6 of 60 (10%)	0 of 60
Placebo	0 of 58 (0%)	2 of 58 (3.4%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42836930Arnaldi D, Bliwise DL, Alpan D, Koochaki P, Meinel M, Olivieri A, Rowles R, Satapathy A, Lederer K. Capturing the Patient Voice: Qualitative Assessment of Daridorexant's Impact on Patients with Insomnia and Comorbid Nocturia from a Randomized, Placebo-Controlled Crossover Trial. Adv Ther. 2026 Oct 6. doi: 10.1007/s12325-026-03803-0. Online ahead of print.
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.

16 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Daridorexant in people with Insomnia Disorder and Nocturia, run by Idorsia Pharmaceuticals Ltd. at 16 sites in 3 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 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Spain, United States, Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 18 Apr 2025). 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 Week 4 in sTST (time frame: From baseline to Week 4 per treatment period.). 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 NCT05597020, 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 18 Apr 2025.