InsomniaNCT07847021
A Multicenter Observational Study of Daridorexant in the Treatment of Insomnia
An observational study of Insomnia, run by Shanghai Mental Health Center at 25 sites in China.
Trial summary
This study aims to evaluate the effectiveness and safety of daridorexant, a novel dual orexin receptor antagonist (DORA), in patients with insomnia. The study population consists of patients aged 18 years and older who present with core insomnia symptoms as defined in the Chinese Guidelines for the Diagnosis and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Daridorexant 50 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 25 sitesChina
- Study dates
- 1 Oct 2026to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults (aged ≥18 years) who agree to participate in the study and core insomnia symptoms documented by the physician during routine clinical care, as defined in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia (2023 Edition) , with symptoms occurring at least 3 times per week and accompanied by daytime functional impairment or daytime distress:
Who may be able to join
- Adults (aged ≥18 years) of either sex who agree to participate in the study.
- Core insomnia symptoms documented by the physician during routine clinical care, as defined in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia (2023 Edition) (meeting at least one of the following criteria), with symptoms occurring at least 3 times per week and accompanied by daytime functional impairment or daytime distress:
- Difficulty initiating sleep (sleep latency exceeding 30min in adults);
- Difficulty maintaining sleep (≥2 nocturnal awakenings);
- Early morning awakening, reduced sleep quality, and reduced total sleep time (usually <6.5h).
- Insomnia Severity Index (ISI) score >7.
- Ability to ensure at least 7 hours of time in bed.
- Participants sign the informed consent form after the study drug prescription has been issued.
Who cannot join
- Participants who are unable to understand and complete the various scales and questionnaire assessments.
- Patients whose insomnia symptoms have shown no significant improvement after standardized treatment with two or more concomitant hypnotic agents (including benzodiazepines, non-benzodiazepine hypnotics, orexin receptor antagonists, and sedating antidepressants/antipsychotics).
- Generalized Anxiety Disorder-7 (GAD-7) score ≥15.
- Patient Health Questionnaire-9 (PHQ-9) score ≥ 20.
- Patients who answer "yes" to Item 4 or Item 5 of the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS), or who have a history of suicide attempt in the suicidal behavior section.
- Patients with severe mental disorders (including but not limited to schizophrenia, schizoaffective disorder, paranoid psychosis, bipolar disorder, mental disorder due to epilepsy, and intellectual developmental disorder with comorbid mental disorder) who are currently in an acute episode or whose condition is unstable, and who, in the investigator's judgment, may compromise trial adherence, be unable to complete the full follow-up, or present a significant safety risk.
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- A history of serious illness, concomitant medication use, cognitive impairment, or uncontrolled poor sleep habits that, in the investigator's judgment, would interfere with study assessments or participant safety.
- Any contraindication or other condition precluding use as specified in the precautions of the package insert (e.g., hypersensitivity to daridorexant or to any of the excipients, narcolepsy, severe hepatic impairment, pregnancy, or lactation).
- Any other condition that the clinician judges to render participation inappropriate.
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
China25 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Dantao Peng, 13910908579, pengdantao@medmail.com.cn
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, 100039
Zhao Dong, 18910685535, dong_zhaozhao@126.com
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, 100096
Fude Yang, 13651336121, yangfd200@126.com
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
Guangxian Nan, 13404320500, nangx@jlu.edu.cn
Hunan Provincial People's Hospital
Changsha, Hunan, 410000
Zhihong Zhao, 13574811976, 1019200187@qq.com
Chaohu Hospital of Anhui Medical University
Chaohu, Anhui, 238000
Kai Zhang, 151 5681 5860, zhangkai@ahmu.edu.cn
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Jiajun Xu, 17381883373, xujiajun120@126.com
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Zefeng Tan, 15918479307, tanzaister@gmail.com
Fuzhou Second General Hospital Neuropsychiatric Prevention and Treatment Hospital
Fuzhou, Fujian, 350412
Weidong Cong, 13906907704, congweidong@fjmu.edu.cn
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Zheng Lin, 13606509130, linzzr@126.com
Harbin First Specialized Hospital
Harbin, Heilongjiang, 150000
Jia Xu, 15046091177, xujiaxujia132129@sina.com
The Second People's Hospital of Hefei
Hefei, Anhui, 230011
Xia Mingwu, 13965030229, xiamingwu1965@163.com
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650000
Yunhui Lv, 18908856668, lyhys99@163.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Yingqiong Xiong, 13970933122, xyq21cn@139.com
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029
Dong Cao, 13512544664, caodong@njmu.edu.cn
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Gang Wang, 15900616110, wanggang@renji.com
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Min Zhao, 18017311005, drminzhao@gmail.com
Shanghai Putuo District People's Hospital
Shanghai, Shanghai Municipality, 200333
Wei Lu, 13817334716, luwei23@tongji.edu.cn
The Fourth People's Hospital of Shantou
Shantou, Guangdong, 515021
Yinglin Zhao, 18666683215, zyl2001@sina.com
Suzhou Guangji Hospital
Suzhou, Jiangsu, 215004
Chuanwei Li, 18817821822, avylee@163.com
Taiyuan Psychiatric Hospital
Taiyuan, Shanxi, 030045
Zhiyong Ren, 13994264404, renzy2011@163.com
Wuhan Mental Health Center
Wuhan, Hubei, 430030
Junhong Zhu, 13971639052, 826627078@qq.com
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068
Wei Li, 18066895168, liwei.996@163.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Yusheng Li, 18337120001, fccliyusheng@zzu.edu.cn
Zhongshan People's Hospital
Zhongshan, Guangdong, 528403
Dan Zhang, 136 3119 2184, danzhangjxmu@163.com
About this study
Official title: Real-World Efficacy and Safety of Daridorexant in Chinese Patients With Insomnia (DREAM-Real): A Multicenter, Prospective Observational Study
This study aims to evaluate the effectiveness and safety of daridorexant, a novel dual orexin receptor antagonist (DORA), in patients with insomnia. The study population consists of patients aged 18 years and older who present with core insomnia symptoms as defined in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia (2023 Edition); eligible patients will receive daridorexant for 16 weeks and will be followed up for improvement in insomnia symptoms and for the occurrence of adverse events, so as to provide real-world evidence to inform the optimization of clinical treatment strategies for insomnia.
Read the detailed description
Background: Insomnia is a highly prevalent sleep disorder that markedly impairs quality of life, with the prevalence of insomnia symptoms ranging from 30% to 48%. Long-term use of benzodiazepines may result in daytime sleepiness, cognitive impairment, tolerance, and risk of dependence, and has even been associated with early-onset dementia; daridorexant avoids many of the adverse effects associated with conventional hypnotic agents. Daridorexant was approved for marketing in China in June 2025; however, large-sample real-world studies of daridorexant are currently lacking. Hypothesis: Daridorexant administered for 16 weeks significantly improves symptoms in patients with insomnia, with a favorable safety profile. Design: A multicenter, prospective, single-arm, observational study with a planned enrollment of 500 patients (assuming an estimated dropout rate of 15%). Patients will receive treatment for 16 weeks, and outcomes will be assessed as the change from baseline in the Insomnia Severity Index (ISI), in sleep parameters (sleep efficiency [SE] and total sleep time [TST]), in the Epworth Sleepiness Scale (ESS) score, in the Clinical Global Impression-Improvement (CGI-I) scale, in the Patient Global Impression-Improvement (PGI-I) scale, and in the 36-Item Short-Form Health Survey (SF-36).
- Conditions
- Insomnia
- Being tested
- Daridorexant 50 mg
- Keywords
- daridorexant, insomnia, dual orexin receptor antagonist, real-world study
- 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 50 mgDrug
Daridorexant hydrochloride tablets (50mg, 20 tablets/box; distributor: Jiangsu Simcere Pharmaceutical Co., Ltd.; store at no more than 30°C). Administered orally: daridorexant 50mg, taken no more than once per night immediately before bedtime, with at least 7 hours remaining before the planned time of awakening.
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant Treatment Group | All enrolled patients receive daridorexant treatment for a 16-week study period. Receives: Drug: Daridorexant 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI) score
Change from baseline in the Insomnia Severity Index (ISI) score at week 4 of treatment. ISI total score ranges 0-28; higher scores represent more severe insomnia (worse outcome).
Measured: 4 Week
Secondary outcomes (11)
Change from baseline in the Insomnia Severity Index (ISI) score at Weeks 8 and 12
Change from baseline in the Insomnia Severity Index (ISI) score at Weeks 8 and 12 of treatment. The Insomnia Severity Index is a 7-item self-rated scale with total scores ranging from 0 to 28. Higher ISI scores indicate greater severity of insomnia (worse outcome).
Measured: Weeks 8 and 12
Insomnia remission rate
Insomnia remission rate at Weeks 4, 8, and 12, defined as the proportion of patients with an ISI score <8;
Measured: Weeks 4, 8, and 12
Proportion of treatment responders
Proportion of treatment responders among patients with moderate-to-severe insomnia at Weeks 4, 8, and 12 (responder defined as a total ISI reduction of ≥6 points from baseline; moderate-to-severe insomnia defined as an ISI score ≥15);
Measured: Weeks 4, 8, and 12
Change from baseline in sleep efficiency (SE)
Change from baseline in sleep efficiency (SE) at Weeks 4, 8, and 12 of treatment. Sleep efficiency is calculated as the percentage of time spent asleep relative to time in bed. SE ranges from 0% to 100%; higher values indicate better sleep.
Measured: Weeks 4, 8, and 12
Change from baseline in the Epworth Sleepiness Scale (ESS) score
Change from baseline in the Epworth Sleepiness Scale (ESS) score at Weeks 4, 8, and 12. ESS total score ranges 0-24; higher scores represent more severe daytime sleepiness (worse outcome).
Measured: Weeks 4, 8, and 12
Change from baseline in the Clinical Global Impression-Improvement (CGI-I) scale score
Change from baseline in the Clinical Global Impression-Improvement (CGI-I) scale score at Weeks 4, 8, and 12 of treatment. The CGI-I is a 7-point clinician-rated scale ranging from 1 to 7. Lower scores indicate greater clinical improvement (better outcome).
Measured: Weeks 4, 8, and 12
Change from baseline in the Patient Global Impression-Improvement (PGI-I) scale score
Change from baseline in the Patient Global Impression-Improvement (PGI-I) scale score at Week 16 of treatment. The PGI-I is a 7-point patient-rated scale ranging from 1 to 7. Lower scores indicate greater patient-perceived clinical improvement (better outcome).
Measured: Week 16
Change from baseline in the 36-Item Short-Form Health Survey (SF-36)
Change from baseline in the 36-Item Short-Form Health Survey (SF-36) score at Week 12 of treatment. The SF-36 is a self-reported health questionnaire comprising 8 domains. Domain and summary scores range from 0 to 100. Higher scores indicate better health-related quality of life (better outcome).
Measured: Week 12
Change from baseline in the Insomnia Severity Index (ISI) score across the three treatment modalities
Change from baseline in the Insomnia Severity Index (ISI) score at Weeks 4, 8, and 12 of treatment, compared across three treatment modalities (treatment-naïve therapy, switch therapy, and add-on therapy). The Insomnia Severity Index is a 7-item self-rated scale with total scores ranging from 0 to 28. Higher ISI scores indicate greater severity of insomnia (worse outcome).
Measured: Weeks 4, 8, and 12
Change in the pre-existing treatment regimen in the non-treatment-naïve group
Change in the pre-existing treatment regimen in the non-treatment-naïve group at Weeks 4, 8, and 12 (success rate of dose reduction or discontinuation of prior medications);
Measured: Weeks 4, 8, and 12
Daridorexant continuation rate and reasons for discontinuation
Daridorexant continuation rate and reasons for discontinuation at Weeks 4, 8, 12, and 16 (continuation rate defined as the percentage of participants who remain on daridorexant treatment, irrespective of treatment modality).
Measured: Weeks 4, 8, 12, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847021
- Sponsor's protocol ID
- MZhao-031
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Efficacy and Safety of Daridorexant in Chinese Patients With Insomnia (DREAM-Real): A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07847021
- Acronym / sponsor ID
- MZhao-031
- Conditions
- Insomnia
- Keywords
- daridorexant, insomnia, dual orexin receptor antagonist, real-world study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Sep 2026 (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 aims to evaluate the effectiveness and safety of daridorexant, a novel dual orexin receptor antagonist (DORA), in patients with insomnia. The study population consists of patients aged 18 years and older who present with core insomnia symptoms as defined in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia (2023 Edition); eligible patients will receive daridorexant for 16 weeks and will be followed up for improvement in insomnia symptoms and for the occurrence of adverse events, so as to provide real-world evidence to inform the optimization of clinical treatment strategies for insomnia.
Detailed description
Background: Insomnia is a highly prevalent sleep disorder that markedly impairs quality of life, with the prevalence of insomnia symptoms ranging from 30% to 48%. Long-term use of benzodiazepines may result in daytime sleepiness, cognitive impairment, tolerance, and risk of dependence, and has even been associated with early-onset dementia; daridorexant avoids many of the adverse effects associated with conventional hypnotic agents. Daridorexant was approved for marketing in China in June 2025; however, large-sample real-world studies of daridorexant are currently lacking. Hypothesis: Daridorexant administered for 16 weeks significantly improves symptoms in patients with insomnia, with a favorable safety profile. Design: A multicenter, prospective, single-arm, observational study with a planned enrollment of 500 patients (assuming an estimated dropout rate of 15%). Patients will receive treatment for 16 weeks, and outcomes will be assessed as the change from baseline in the Insomnia Severity Index (ISI), in sleep parameters (sleep efficiency [SE] and total sleep time [TST]), in the Epworth Sleepiness Scale (ESS) score, in the Clinical Global Impression-Improvement (CGI-I) scale, in the Patient Global Impression-Improvement (PGI-I) scale, and in the 36-Item Short-Form Health Survey (SF-36).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daridorexant Treatment Group | – | Drug: Daridorexant 50 mgAll enrolled patients receive daridorexant treatment for a 16-week study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (aged ≥18 years) who agree to participate in the study and core insomnia symptoms documented by the physician during routine clinical care, as defined in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia (2023 Edition) , with symptoms occurring at least 3 times per week and accompanied by daytime functional impairment or daytime distress:
Key inclusion criteria (8 listed)
- Adults (aged ≥18 years) of either sex who agree to participate in the study.
- Core insomnia symptoms documented by the physician during routine clinical care, as defined in the Chinese Guidelines for the Diagnosis and Treatment of Insomnia (2023 Edition) (meeting at least one of the following criteria), with symptoms occurring at least 3 times per week and accompanied by daytime functional impairment or daytime distress:
- Insomnia Severity Index (ISI) score >7.
- Ability to ensure at least 7 hours of time in bed.
- Participants sign the informed consent form after the study drug prescription has been issued.
Key exclusion criteria (9 listed)
- Participants who are unable to understand and complete the various scales and questionnaire assessments.
- Patients whose insomnia symptoms have shown no significant improvement after standardized treatment with two or more concomitant hypnotic agents (including benzodiazepines, non-benzodiazepine hypnotics, orexin receptor antagonists, and sedating antidepressants/antipsychotics).
- Generalized Anxiety Disorder-7 (GAD-7) score ≥15.
- Patient Health Questionnaire-9 (PHQ-9) score ≥ 20.
- Patients who answer "yes" to Item 4 or Item 5 of the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS), or who have a history of suicide attempt in the suicidal behavior section.
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 50 mgDaridorexant hydrochloride tablets (50mg, 20 tablets/box; distributor: Jiangsu Simcere Pharmaceutical Co., Ltd.; store at no more than 30°C). Administered orally: daridorexant 50mg, taken no more than once per night immediately before bedtime, with at least 7 hours remaining before the planned time of awakening. | Drug | Daridorexant Treatment Group |
Primary outcome
Change in Insomnia Severity Index (ISI) score
Time frame: 4 Week
Change from baseline in the Insomnia Severity Index (ISI) score at week 4 of treatment. ISI total score ranges 0-28; higher scores represent more severe insomnia (worse outcome).
11 secondary outcomes
Change from baseline in the Insomnia Severity Index (ISI) score at Weeks 8 and 12
Time frame: Weeks 8 and 12
Insomnia remission rate
Time frame: Weeks 4, 8, and 12
Proportion of treatment responders
Time frame: Weeks 4, 8, and 12
Change from baseline in sleep efficiency (SE)
Time frame: Weeks 4, 8, and 12
Change from baseline in the Epworth Sleepiness Scale (ESS) score
Time frame: Weeks 4, 8, and 12
Change from baseline in the Clinical Global Impression-Improvement (CGI-I) scale score
Time frame: Weeks 4, 8, and 12
Change from baseline in the Patient Global Impression-Improvement (PGI-I) scale score
Time frame: Week 16
Change from baseline in the 36-Item Short-Form Health Survey (SF-36)
Time frame: Week 12
Change from baseline in the Insomnia Severity Index (ISI) score across the three treatment modalities
Time frame: Weeks 4, 8, and 12
Change in the pre-existing treatment regimen in the non-treatment-naïve group
Time frame: Weeks 4, 8, and 12
Daridorexant continuation rate and reasons for discontinuation
Time frame: Weeks 4, 8, 12, and 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- 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.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by Shanghai Mental Health Center at 25 sites in China.
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 8 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenzheng Wang (021-34773758, fffty@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) score (time frame: 4 Week). 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 29 Sep 2026.