Insomnia ChronicNCT07132086
Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting
An observational study of Insomnia Chronic, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial summary
The primary objectives of this study is to evaluate the real-world effectiveness of daridorexant 50 mg in improving both subjective (self-report) and objective (actigraphic) sleep parameters in patients with chronic insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Daridorexant 50 mg orally, once daily at bedtime, administered as monotherapy or add-on therapy for chronic insomnia, in a real-world, observational, prospective clinical setting
- Type of treatment
- Pill or oral medicine
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2023to 30 Jun 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with a clinical diagnosis of chronic insomnia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, evaluated at the Neurology Clinic of the Azienda Ospedaliero-Universitaria Pisana (AOUP), Italy. Participants will be selected among those who receive a new prescription of daridorexant or another guideline-recommended treatment for insomnia. The population includes individuals with or without comorbid sleep disorders (e.g., RLS, OSA, circadian rhythm disorders). Both treatment-naïve patients and those previously treated with other insomnia therapies may be included, provided they meet inclusion criteria and give informed consent.
Who may be able to join
- Age ≥ 18 years
- Signed informed consent form
- Diagnosis of chronic insomnia according to DSM-5 criteria, defined as:
- Dissatisfaction with sleep quantity or quality, associated with one or more of the following:
- Difficulty initiating sleep
- Difficulty maintaining sleep (frequent awakenings or trouble returning to sleep)
Show all 12Show fewer
- Early morning awakenings with inability to return to sleep
- The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, or other important areas of functioning
- Sleep difficulties occur despite adequate opportunity and circumstances for sleep
- The insomnia is not better explained by or occurring exclusively during other sleep-wake disorders (e.g., narcolepsy, parasomnias, circadian rhythm sleep-wake disorders, breathing-related sleep disorders)
- The insomnia is not attributable to the physiological effects of a substance (e.g., drug abuse or medication)
- No contraindications to daridorexant use according to the European Medicines Agency (EMA)
Who cannot join
- Pregnancy
- Breastfeeding
- Withdrawal of informed consent at any time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia Using Subjective and Actigraphic Sleep Measures in a Real-World Setting
The primary objectives of this study is to evaluate the real-world effectiveness of daridorexant 50 mg in improving both subjective (self-report) and objective (actigraphic) sleep parameters in patients with chronic insomnia.
The secondary aims of this study are:
- To compare the effectiveness of daridorexant 50 mg with other guideline-recommended therapies for chronic insomnia in improving sleep parameters and sleep health.
- To identify clinical and demographic predictors of response to daridorexant 50 mg, such as age, sex, BMI, duration of insomnia, and treatment regimen (monotherapy vs. add-on).
- To monitor changes over time in the symptoms related to comorbid sleep disorders (e.g., OSA, RLS, circadian rhythm disorders) in patients treated with daridorexant 50 mg.
Read the detailed description
Insomnia affects approximately 10% of the European population and represents a significant risk factor for multiple chronic conditions, including cardiovascular diseases, depression, and type II diabetes. The latest European Guidelines for the Management of Insomnia have included daridorexant among the first-line pharmacological options for chronic insomnia. Daridorexant is a dual orexin receptor antagonist (DORA) that offers advantages over traditional hypnotics by avoiding common adverse effects such as residual daytime sedation, impaired motor coordination, and the risk of dependence.
Clinical trials have demonstrated that DORAs, including daridorexant, are effective in improving several subjective and objective sleep parameters. However, no studies to date have investigated predictors of treatment response in patients with insomnia receiving daridorexant, despite increasing awareness of the need for personalized pharmacological strategies.
In pivotal trials, daridorexant efficacy was evaluated using both subjective (patient-reported) and objective (polysomnographic) sleep outcomes. While polysomnography (PSG) is the gold standard for objective sleep evaluation, it is poorly suited for long-term, real-world monitoring due to cost, complexity, and reduced ecological validity. In contrast, actigraphy allows for non-invasive, home-based sleep-wake monitoring through wrist movement detection over multiple nights and is widely used in sleep research and clinical settings. However, no studies have employed actigraphy to assess daridorexant's real-world effectiveness, leaving a significant knowledge gap.
Another relevant aspect is the frequent co-occurrence of insomnia with other sleep disorders such as restless legs syndrome (RLS), circadian rhythm sleep-wake disorders, and obstructive sleep apnea (OSA). Evaluating the evolution of symptoms related to these comorbid sleep conditions in patients treated with daridorexant could help clarify whether its use should be expanded or restricted in certain clinical populations.
Study Objectives and Outcome Measures
Primary Objectives:
To evaluate the real-world effectiveness of daridorexant 50 mg in improving both subjective (questionnaire-based) and objective (actigraphy-based) sleep parameters in patients with chronic insomnia.
Secondary Objectives:
To compare the effectiveness of daridorexant 50 mg with other guideline-recommended therapies for chronic insomnia in improving sleep parameters and sleep health.
To identify clinical and demographic predictors of response to daridorexant 50 mg, such as age, sex, BMI, duration of insomnia, and treatment regimen (monotherapy vs. add-on).
To monitor changes over time in the symptoms related to comorbid sleep disorders (e.g., OSA, RLS, circadian rhythm disorders) in patients treated with daridorexant 50 mg.
Primary Endpoint:
This is the first prospective observational study aiming to assess the real-world effectiveness of daridorexant 50 mg in improving both subjective and actigraphic sleep parameters in patients with chronic insomnia. In addition, the study will evaluate possible changes in circadian metrics over time, with the goal of better understanding the impact of daridorexant on patients' sleep-wake rhythm under real-life conditions.
- Conditions
- Insomnia Chronic
- Being tested
- Daridorexant 50 mg orally, once daily at bedtime, administered as monotherapy or add-on therapy for chronic insomnia, in a real-world, observational, prospective clinical setting
- 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 mg orally, once daily at bedtime, administered as monotherapy or add-on therapy for chronic insomnia, in a real-world, observational, prospective clinical settingDrug
Also called Quviviq 50 mg
Daridorexant 50 mg is administered once daily at bedtime, either as monotherapy or as add-on therapy in patients with chronic insomnia. The intervention is evaluated in a naturalistic, real-world setting over a 3-month observational period. Both subjective (questionnaires, sleep diary) and objective (actigraphy) sleep parameters are collected at baseline, 1 month, and 3 months. Actigraphy is used to assess total sleep time, sleep efficiency, wake after sleep onset, and circadian rhythm parameters. Sleep misperception is calculated as the discrepancy between subjective and objective sleep metrics. The study also explores potential predictors of treatment response such as age, sex, BMI, insomnia duration, and comorbid sleep disorders.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total sleep time after 3 months of daridorexant treatment
This outcome assesses the change in both subjective (patient-reported) and objective (actigraphic) total sleep time (TST) from baseline to 3 months after initiating daridorexant 50 mg.
Primary Outcome Measures:
- Change in subjective TST [minutes/night]
- Change in actigraphic TST [minutes/night]
Measured: From baseline (Day 0) to 3 months after treatment initiation
Change in wake after sleep onset after 3 months of daridorexant treatment
This outcome assesses the change in both subjective (patient-reported) and objective (actigraphic) wake after sleep onset (WASO) from baseline to 3 months after initiating daridorexant 50 mg.
Primary Outcome Measures:
- Change in subjective WASO [minutes/night]
- Change in actigraphic WASO [minutes/night]
Measured: From baseline (Day 0) to 3 months after treatment initiation
Change in sleep efficiency after 3 months of daridorexant treatment
This outcome assesses the change in both subjective (patient-reported) and objective (actigraphic) sleep efficiency (SE) from baseline to 3 months after initiating daridorexant 50 mg.
Primary Outcome Measures:
- Change in subjective SE. Subjective SE is estimated as the ratio of subjective TST to Time in bed [%]
- Change in actigraphic SE. Actigraphic SE is estimated as the ratio of actigraphic TST to Time in bed [%]
Measured: From baseline (Day 0) to 3 months after treatment initiation
Change in sleep regularity index after 3 months of daridorexant treatment
This outcome assesses the change in objective (actigraphic) sleep regularity index (SRI) from baseline to 3 months after initiating daridorexant 50 mg.
Primary Outcome Measure:
- Change in Sleep Regularity Index (SRI) [%]
Measured: From baseline (Day 0) to 3 months after treatment initiation
Change in self-reported sleep questionnaires after 3 months of daridorexant treatment
This outcome assesses the change in self-reported sleep questionnaires from baseline to 3 months after initiating daridorexant 50 mg.
Primary Outcome Measures:
- Change in sleep quality (PSQI score) [range: 0-21]
- Change in insomnia severity (ISI score) [range: 0-28]
- Change in daytime functioning and alertness (IDSIQ total score) [range: 0-100]
Measured: From baseline (Day 0) to 3 months after treatment initiation
Secondary outcomes (3)
Change in TST misperception after 3 months of daridorexant treatment
This outcome assesses the change in TST misperception from baseline to 3 months after initiating daridorexant 50 mg.
TST misperception is calculated as the difference between subjective and actigraphic TST (hours)
Measured: From baseline (Day 0) to 3 months after treatment initiation
Change in SE misperception after 3 months of daridorexant treatment
This outcome assesses the change in SE misperception from baseline to 3 months after initiating daridorexant 50 mg.
SE misperception is calculated as the difference between subjective and actigraphic SE (%)
Measured: From baseline (Day 0) to 3 months after treatment initiation
Change in WASO misperception after 3 months of daridorexant treatment
This outcome assesses the change in WASO misperception from baseline to 3 months after initiating daridorexant 50 mg.
WASO misperception is calculated as the difference between subjective and actigraphic WASO (minutes)
Measured: From baseline (Day 0) to 3 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Oct 2023
- Primary completion1 Mar 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrica Bonanni, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Enrica Bonanni, MD, PhD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132086
- Sponsor's protocol ID
- 57/2025
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia Using Subjective and Actigraphic Sleep Measures in a Real-World Setting
- ClinicalTrials.gov ID
- NCT07132086
- Acronym / sponsor ID
- 57/2025
- Conditions
- Insomnia Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 20 Aug 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 primary objectives of this study is to evaluate the real-world effectiveness of daridorexant 50 mg in improving both subjective (self-report) and objective (actigraphic) sleep parameters in patients with chronic insomnia.
The secondary aims of this study are:
- To compare the effectiveness of daridorexant 50 mg with other guideline-recommended therapies for chronic insomnia in improving sleep parameters and sleep health.
- To identify clinical and demographic predictors of response to daridorexant 50 mg, such as age, sex, BMI, duration of insomnia, and treatment regimen (monotherapy vs. add-on).
- To monitor changes over time in the symptoms related to comorbid sleep disorders (e.g., OSA, RLS, circadian rhythm disorders) in patients treated with daridorexant 50 mg.
Detailed description
Insomnia affects approximately 10% of the European population and represents a significant risk factor for multiple chronic conditions, including cardiovascular diseases, depression, and type II diabetes. The latest European Guidelines for the Management of Insomnia have included daridorexant among the first-line pharmacological options for chronic insomnia. Daridorexant is a dual orexin receptor antagonist (DORA) that offers advantages over traditional hypnotics by avoiding common adverse effects such as residual daytime sedation, impaired motor coordination, and the risk of dependence.
Clinical trials have demonstrated that DORAs, including daridorexant, are effective in improving several subjective and objective sleep parameters. However, no studies to date have investigated predictors of treatment response in patients with insomnia receiving daridorexant, despite increasing awareness of the need for personalized pharmacological strategies.
In pivotal trials, daridorexant efficacy was evaluated using both subjective (patient-reported) and objective (polysomnographic) sleep outcomes. While polysomnography (PSG) is the gold standard for objective sleep evaluation, it is poorly suited for long-term, real-world monitoring due to cost, complexity, and reduced ecological validity. In contrast, actigraphy allows for non-invasive, home-based sleep-wake monitoring through wrist movement detection over multiple nights and is widely used in sleep research and clinical settings. However, no studies have employed actigraphy to assess daridorexant's real-world effectiveness, leaving a significant knowledge gap.
Another relevant aspect is the frequent co-occurrence of insomnia with other sleep disorders such as restless legs syndrome (RLS), circadian rhythm sleep-wake disorders, and obstructive sleep apnea (OSA). Evaluating the evolution of symptoms related to these comorbid sleep conditions in patients treated with daridorexant could help clarify whether its use should be expanded or restricted in certain clinical populations.
Study Objectives and Outcome Measures
Primary Objectives:
To evaluate the real-world effectiveness of daridorexant 50 mg in improving both subjective (questionnaire-based) and objective (actigraphy-based) sleep parameters in patients with chronic insomnia.
Secondary Objectives:
To compare the effectiveness of daridorexant 50 mg with other guideline-recommended therapies for chronic insomnia in improving sleep parameters and sleep health.
To identify clinical and demographic predictors of response to daridorexant 50 mg, such as age, sex, BMI, duration of insomnia, and treatment regimen (monotherapy vs. add-on).
To monitor changes over time in the symptoms related to comorbid sleep disorders (e.g., OSA, RLS, circadian rhythm disorders) in patients treated with daridorexant 50 mg.
Primary Endpoint:
This is the first prospective observational study aiming to assess the real-world effectiveness of daridorexant 50 mg in improving both subjective and actigraphic sleep parameters in patients with chronic insomnia. In addition, the study will evaluate possible changes in circadian metrics over time, with the goal of better understanding the impact of daridorexant on patients' sleep-wake rhythm under real-life conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with a clinical diagnosis of chronic insomnia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, evaluated at the Neurology Clinic of the Azienda Ospedaliero-Universitaria Pisana (AOUP), Italy. Participants will be selected among those who receive a new prescription of daridorexant or another guideline-recommended treatment for insomnia. The population includes individuals with or without comorbid sleep disorders (e.g., RLS, OSA, circadian rhythm disorders). Both treatment-naïve patients and those previously treated with other insomnia therapies may be included, provided they meet inclusion criteria and give informed consent.
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Signed informed consent form
- Diagnosis of chronic insomnia according to DSM-5 criteria, defined as:
- Dissatisfaction with sleep quantity or quality, associated with one or more of the following:
- Difficulty initiating sleep
Key exclusion criteria (3 listed)
- Pregnancy
- Breastfeeding
- Withdrawal of informed consent at any time
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 mg orally, once daily at bedtime, administered as monotherapy or add-on therapy for chronic insomnia, in a real-world, observational, prospective clinical settingAlso: Quviviq 50 mgDaridorexant 50 mg is administered once daily at bedtime, either as monotherapy or as add-on therapy in patients with chronic insomnia. The intervention is evaluated in a naturalistic, real-world setting over a 3-month observational period. Both subjective (questionnaires, sleep diary) and objective (actigraphy) sleep parameters are collected at baseline, 1 month, and 3 months. Actigraphy is used to assess total sleep time, sleep efficiency, wake after sleep onset, and circadian rhythm parameters. Sleep misperception is calculated as the discrepancy between subjective and objective sleep metrics. The study also explores potential predictors of treatment response such as age, sex, BMI, insomnia duration, and comorbid sleep disorders. | Drug | – |
Primary outcome
Change in total sleep time after 3 months of daridorexant treatment
Time frame: From baseline (Day 0) to 3 months after treatment initiation
This outcome assesses the change in both subjective (patient-reported) and objective (actigraphic) total sleep time (TST) from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measures: * Change in subjective TST [minutes/night] * Change in actigraphic TST [minutes/night]
Change in wake after sleep onset after 3 months of daridorexant treatment
Time frame: From baseline (Day 0) to 3 months after treatment initiation
This outcome assesses the change in both subjective (patient-reported) and objective (actigraphic) wake after sleep onset (WASO) from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measures: * Change in subjective WASO [minutes/night] * Change in actigraphic WASO [minutes/night]
Change in sleep efficiency after 3 months of daridorexant treatment
Time frame: From baseline (Day 0) to 3 months after treatment initiation
This outcome assesses the change in both subjective (patient-reported) and objective (actigraphic) sleep efficiency (SE) from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measures: * Change in subjective SE. Subjective SE is estimated as the ratio of subjective TST to Time in bed [%] * Change in actigraphic SE. Actigraphic SE is estimated as the ratio of actigraphic TST to Time in bed [%]
Change in sleep regularity index after 3 months of daridorexant treatment
Time frame: From baseline (Day 0) to 3 months after treatment initiation
This outcome assesses the change in objective (actigraphic) sleep regularity index (SRI) from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measure: - Change in Sleep Regularity Index (SRI) [%]
Change in self-reported sleep questionnaires after 3 months of daridorexant treatment
Time frame: From baseline (Day 0) to 3 months after treatment initiation
This outcome assesses the change in self-reported sleep questionnaires from baseline to 3 months after initiating daridorexant 50 mg. Primary Outcome Measures: * Change in sleep quality (PSQI score) [range: 0-21] * Change in insomnia severity (ISI score) [range: 0-28] * Change in daytime functioning and alertness (IDSIQ total score) [range: 0-100]
3 secondary outcomes
Change in TST misperception after 3 months of daridorexant treatment
Time frame: From baseline (Day 0) to 3 months after treatment initiation
Change in SE misperception after 3 months of daridorexant treatment
Time frame: From baseline (Day 0) to 3 months after treatment initiation
Change in WASO misperception after 3 months of daridorexant treatment
Time frame: From baseline (Day 0) to 3 months after treatment initiation
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 20 Aug 2025.
- 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. This study is not recruiting at the moment.
Enrica Bonanni, MD, PhD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia Chronic, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
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 12 inclusion and 3 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 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
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?
Change in total sleep time after 3 months of daridorexant treatment (time frame: From baseline (Day 0) to 3 months after treatment initiation). The study lists 5 primary outcomes in all. 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 20 Aug 2025.