Insomia Disorder study: Daridorexant
Official title 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
ClinicalTrials.gov ID: NCT07843329
What this study is testing
What is Daridorexant?
Daridorexant is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for insomia disorder.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 3 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Adequate opportunity for sleep (time in bed ≥ 7 hours for at least 3 valid recorded nights) confirmed by objective measurements obtained using the...
You likely can't join if
- Body mass index \ 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
See the full eligibility criteria
- 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...
- 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...
- 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...
- Body mass index \ 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
The study team makes the final eligibility decision.
Where it is enrolling
- Virginia Gardens, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Virginia Gardens, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.