Insomnia DisorderPhase 3NCT07028697
A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder
A Phase 3 study testing Daridorexant in people with Insomnia Disorder, run by Nxera Pharma Korea Co., Ltd. at 17 sites in South Korea.
Trial summary
The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Insomnia Disorder
- 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
- 164 participants
- Where
- 17 sitesSouth Korea
- Study dates
- 4 Dec 2024to 21 Oct 2025
- Phase
- Phase 3
- 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 19 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 ≥ 19 years;
- Insomnia disorder according to DSM-5 criteria;
- The predominant complaint is dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
- Difficulty initiating sleep.
- Difficulty maintaining sleep (characterized by frequent awakenings or problems returning to sleep after awakenings).
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- Early-morning awakening with inability to return to sleep.
- Insomnia Severity Index score ≥ 15;
- Insufficient sleep quantity as collected subjectively in the sleep diary A. ≥ 30 min to fall asleep, and B. Wake time during sleep ≥ 30 min, and C. Subjective Total Sleep Time (sTST) ≤ 6.5 h
Who cannot join
- Body mass index (BMI) ≥ 40.0 kg/m2
- Documented medical history and/or comorbidity of sleep-related breathing disorder
- History of and/or concurrent sleep apnea or suspected sleep apnea
- Korean-Mini Mental State Examination-2 (K-MMSE-2) score < 25 in subjects ≥ 50 years;
- For female subjects: pregnant, lactating or childbearing potential who do not consent to true abstinence or use an effective method of contraception for required period
- Initiation of the cognitive behavior therapy (CBT) for treatment of insomnia disorder within 4 weeks prior to the Screening visit (Visit 1) or planned CBT during the study
- A history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C)
- Positive urine drug test or presence of alcohol in exhaled breath as detected by breathalyzer test.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
South Korea17 sites
Inje University Busan Paik Hospital
Busan, 47392
Pusan National University Yangsan Hospital
Busan, 50612
Soonchunhyang University Cheonan Hospital
Cheonan, 31151
Keimyung University Dongsan Medical Center
Daegu, 42601
Chungnam National University Hospital
Daejeon, 35015
Chonnam National University Hospital
Gwangju, 61469
Inje University Ilsan Paik Hospital
Ilsan, 10380
Gachon University Gil Medical Center
Incheon, 21565
Catholic Kwandong University International St. Mary'S Hospital
Incheon, 22711
Seoul National University Bundang Hospital
Seongnam-si, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Kyung Hee University Hospital At Gangdong
Seoul, 05278
Asan Medical Center
Seoul, 05505
Ewha Womans University Medical Center
Seoul, 07804
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, 16247
Wonju Severance Christian Hospital
Wŏnju, 26426
About this study
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.
- Conditions
- Insomnia Disorder
- Being tested
- Daridorexant, 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.
DaridorexantDrug
Daridorexant will be taken orally, once daily in the evening as indicated by investigator.
PlaceboDrug
Placebo will be taken orally, once daily in the evening as indicated by investigator.
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant | Experimental | Not described Receives: Drug: Daridorexant |
| 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.
Subjective total sleep time(sTST)
Change from baseline to week 4 in subjective total sleep time (sTST) measured by eDairy
Measured: Week 4
Secondary outcomes (2)
Subjective latency to sleep onset (sLSO)
Change from baseline to week 4 in subjective latency to sleep onset (sLSO) measured by eDairy
Measured: Week 4
Subjective wake after sleep onset (WASO)
Change from baseline to week 4 in subjective wake after sleep onset (WASO) measured by eDairy
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start4 Dec 2024
- Primary completion23 Sep 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nxera Pharma Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development, Nxera Pharma Korea Co., Ltd., Study director, Nxera Pharma Korea Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028697
- Sponsor's protocol ID
- NPK-DAR-301
- Status last verified
- Jan 2026
- First submitted
- 11 Jun 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
- ClinicalTrials.gov ID
- NCT07028697
- Acronym / sponsor ID
- NPK-DAR-301
- Conditions
- Insomnia Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Nxera Pharma Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 19 Jun 2025 (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.
The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daridorexant | Experimental | Drug: Daridorexant |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent prior to any study-mandated procedure;
- Male or female aged ≥ 19 years;
- Insomnia disorder according to DSM-5 criteria;
- The predominant complaint is dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
- Difficulty initiating sleep.
Key exclusion criteria (8 listed)
- Body mass index (BMI) ≥ 40.0 kg/m2
- Documented medical history and/or comorbidity of sleep-related breathing disorder
- History of and/or concurrent sleep apnea or suspected sleep apnea
- Korean-Mini Mental State Examination-2 (K-MMSE-2) score < 25 in subjects ≥ 50 years;
- For female subjects: pregnant, lactating or childbearing potential who do not consent to true abstinence or use an effective method of contraception for required period
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 will be taken orally, once daily in the evening as indicated by investigator. | Drug | Daridorexant |
| PlaceboPlacebo will be taken orally, once daily in the evening as indicated by investigator. | Drug | Placebo |
Primary outcome
Subjective total sleep time(sTST)
Time frame: Week 4
Change from baseline to week 4 in subjective total sleep time (sTST) measured by eDairy
2 secondary outcomes
Subjective latency to sleep onset (sLSO)
Time frame: Week 4
Subjective wake after sleep onset (WASO)
Time frame: Week 4
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 21 Jan 2026.
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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 Development, Nxera Pharma Korea Co., Ltd. study director
Nxera Pharma Korea Co., Ltd.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daridorexant in people with Insomnia Disorder, run by Nxera Pharma Korea Co., Ltd. at 17 sites in South Korea.
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 9 inclusion and 8 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Korea. 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?
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?
Subjective total sleep time(sTST) (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.