Insomia DisorderPhase 3DARI-DREAMNCT07843329
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
A Phase 3 study testing Daridorexant in people with Insomia Disorder, run by Idorsia Pharmaceuticals Ltd. at 9 sites in United States.
Trial summary
The purpose of this clinical trial is to collect more data about the effect of daridorexant in adults and elderly people with insomnia disorder. The trial aims to find out whether daridorexant can help improve: how trial participants sleep at night, how trial participants function the next day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomia 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
- 344 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Oct 2026to 6 Dec 2027
- Phase
- Phase 3
- 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
Who may be able to join
- Male or female participants aged ≥ 18 years at the time of signing the ICF
- Insomnia disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders criteria including: Self-reported insufficient sleep quantity defined as subjective Total Sleep Time (TST) ≤ 6.5 hours during the night, associated with difficulties with sleep initiation or maintenance or early-morning awakenings, for at least 3 nights per week during a period of at least 3 months prior to screening visit
- Insomnia Severity Index© score ≥ 15
- Presence of insomnia symptoms (TST ≤ 6.5 hours for at least 3 valid nights recording, and average TST ≤ 6.5 hours over 7 nights) confirmed by objective measurements using a home electroencephalogram (EEG) device over a 7-night period during screening
- Adequate opportunity for sleep (time in bed ≥ 7 hours for at least 3 valid recorded nights) confirmed by objective measurements obtained using the home EEG device during the 7-night assessment period specified in the inclusion criterion above
Who cannot join
- Body mass index < 18.5 or > 40.0 kg/m2
- Any lifetime history of breathing-related sleep disorder
- Presence of an additional sleep-wake disorder
- Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week
- Previous treatment with daridorexant or other dual orexin receptor antagonists at any time prior to Visit 1
- Acute or unstable (i.e., not adequately controlled for at least 1 month) psychiatric condition
- Any suicidal ideation or history of suicide attempt, as assessed by Columbia Suicide Severity Rating Scale© (C-SSRS©), at Visit 1
- Unstable medical condition, which, in the opinion of the investigator, could affect the participant's safety or interfere with the trial assessments
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Not yet recruiting
Teradan Clinical Trials, LLC
Brandon, Florida, 33511
- Not yet recruiting
CTI Clinical Research Center
Cincinnati, Ohio, 45212
- Not yet recruiting
Advanced Respiratory and Sleep Medicince LLC
Huntersville, North Carolina, 28078
- Not yet recruiting
Synergy San Diego
Lemon Grove, California, 91945
- Not yet recruiting
Preferred Research Partners Inc.
Little Rock, Arkansas, 72211
- Not yet recruiting
Empire Clinical Research
Pomona, California, 91767
- Not yet recruiting
Eximia Research - NC, LLC
Raleigh, North Carolina, 27607
- Recruiting
Hope Research Network
Virginia Gardens, Florida, 33166
- Not yet recruiting
Encore Medical Research, LLC - Weston
Weston, Florida, 33331
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy of Daridorexant on Nighttime Symptoms and Daytime Functioning in Adult and Elderly Participants With Insomnia Disorder
The purpose of this clinical trial is to collect more data about the effect of daridorexant in adults and elderly people with insomnia disorder.
The trial aims to find out whether daridorexant can help improve:
Read more
- how trial participants sleep at night,
- how trial participants function the next day.
Researchers will compare daridorexant to a placebo (a look-alike inactive substance that contains no active medicine) to understand which effect daridorexant has on total sleep time and next-day functioning.
Enrolled participants will:
- Take daridorexant 50 mg or placebo once daily for approximately 3 months
- Visit the clinic once every month during treatment for checkups and tests
- Keep a sleep diary of the number of hours they sleep and how well they sleep
- Complete a questionnaire every day about any symptoms of sleepiness during the day and any impact on physical and mental functioning such as energy levels, mood, or ability to concentrate or memorize.
Read the detailed description
The trial includes three trial periods:
Following a Screening period, during which it will be checked if participants are eligible to take part, eligible participants will be randomized in a 1:1 ratio to receive either daridorexant 50 mg or placebo for ca. 3 months (Treatment period). On completion of treatment, participants will be followed for up to 10 days for safety assessments (Safety follow-up period).
Trial participation will end with a Follow-up call (Participant Last Visit) at the end of the Safety follow-up period.
The maximum trial duration for an individual participant will be approximately 4 months.
- Conditions
- Insomia Disorder
- Being tested
- Daridorexant, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaridorexantDrug
Daridorexant 50 mg tablets
PlaceboDrug
Matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Daridorexant | Experimental | Participants will receive 50 mg daridorexant orally, once daily for approximately 3 months. Receives: Drug: Daridorexant |
| Placebo | Placebo comparator | Participants will receive placebo orally, once daily for approximately 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Month 3 in Subjective Total Sleep Time (sTST)
Subjective Total Sleep Time (sTST) is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. A negative change from baseline indicates a decrease in sTST.
Measured: Baseline and Month 3
Secondary outcomes (2)
Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score (SDS)
The 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., Alert/Cognition, Mood, and Sleepiness) reflecting daytime impairment of insomnia. The SDS ranges from 0 to 40. 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: Baseline and Month 3
Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Total Score (TS)
The IDSIQ comprises three domains: Alert/Cognition (maximum score: 60), Mood (maximum score: 40), and Sleepiness (maximum score: 40), resulting in a TS ranging from 0 to 140. 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: Baseline and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start28 Oct 2026
- Primary completion22 Nov 2027 (estimated)
- Study completion6 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomia 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Development, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843329
- Sponsor's protocol ID
- ID-078A306
- Other IDs
- 2026-525730-38-00
- Acronym
- DARI-DREAM
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy of Daridorexant on Nighttime Symptoms and Daytime Functioning in Adult and Elderly Participants With Insomnia Disorder
- ClinicalTrials.gov ID
- NCT07843329
- Acronym / sponsor ID
- DARI-DREAM / ID-078A306
- Conditions
- Insomia Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Oct 2026 (actual)
- Primary completion
- 22 Nov 2027 (estimated)
- Study completion
- 6 Dec 2027 (estimated)
- First posted
- 28 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.
The purpose of this clinical trial is to collect more data about the effect of daridorexant in adults and elderly people with insomnia disorder.
The trial aims to find out whether daridorexant can help improve:
- how trial participants sleep at night,
- how trial participants function the next day.
Researchers will compare daridorexant to a placebo (a look-alike inactive substance that contains no active medicine) to understand which effect daridorexant has on total sleep time and next-day functioning.
Enrolled participants will:
- Take daridorexant 50 mg or placebo once daily for approximately 3 months
- Visit the clinic once every month during treatment for checkups and tests
- Keep a sleep diary of the number of hours they sleep and how well they sleep
- Complete a questionnaire every day about any symptoms of sleepiness during the day and any impact on physical and mental functioning such as energy levels, mood, or ability to concentrate or memorize.
Detailed description
The trial includes three trial periods:
Following a Screening period, during which it will be checked if participants are eligible to take part, eligible participants will be randomized in a 1:1 ratio to receive either daridorexant 50 mg or placebo for ca. 3 months (Treatment period). On completion of treatment, participants will be followed for up to 10 days for safety assessments (Safety follow-up period).
Trial participation will end with a Follow-up call (Participant Last Visit) at the end of the Safety follow-up period.
The maximum trial duration for an individual participant will be approximately 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daridorexant | Experimental | Drug: DaridorexantParticipants will receive 50 mg daridorexant orally, once daily for approximately 3 months. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo orally, once daily for approximately 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged ≥ 18 years at the time of signing the ICF
- Insomnia disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders criteria including: Self-reported insufficient sleep quantity defined as subjective Total Sleep Time (TST) ≤ 6.5 hours during the night, associated with difficulties with sleep initiation or maintenance or early-morning awakenings, for at least 3 nights per week during a period of at least 3 months prior to screening visit
- Insomnia Severity Index© score ≥ 15
- Presence of insomnia symptoms (TST ≤ 6.5 hours for at least 3 valid nights recording, and average TST ≤ 6.5 hours over 7 nights) confirmed by objective measurements using a home electroencephalogram (EEG) device over a 7-night period during screening
- Adequate opportunity for sleep (time in bed ≥ 7 hours for at least 3 valid recorded nights) confirmed by objective measurements obtained using the home EEG device during the 7-night assessment period specified in the inclusion criterion above
Key exclusion criteria (8 listed)
- Body mass index < 18.5 or > 40.0 kg/m2
- Any lifetime history of breathing-related sleep disorder
- Presence of an additional sleep-wake disorder
- Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week
- Previous treatment with daridorexant or other dual orexin receptor antagonists at any time prior to Visit 1
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 50 mg tablets | Drug | Daridorexant |
| PlaceboMatching placebo tablets | Drug | Placebo |
Primary outcome
Change from baseline to Month 3 in Subjective Total Sleep Time (sTST)
Time frame: Baseline and Month 3
Subjective Total Sleep Time (sTST) is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in sTST. A negative change from baseline indicates a decrease in sTST.
2 secondary outcomes
Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score (SDS)
Time frame: Baseline and Month 3
Change from baseline to Month 3 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Total Score (TS)
Time frame: Baseline and Month 3
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 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Insomia Disorder
RecruitingPhase 2
Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
Insomnia Chronic, Older People
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.
Global Clinical Development study director
Idorsia Pharmaceuticals Ltd.
9 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 Insomia Disorder, run by Idorsia Pharmaceuticals Ltd. at 9 sites in United States.
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 5 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
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 Idorsia Clinical Trial Information USA (+1 856 661 37 21, idorsiaclinicaltrials@idorsia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to Month 3 in Subjective Total Sleep Time (sTST) (time frame: Baseline and Month 3). 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 5 Nov 2026.