Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting

NCT07132086 | Completed FDA Drug

• 1 other identifier: 57/2025
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (5)

• 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 \[minutes/night\]

  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 \[minutes/night\]

  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 \[%\]

  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) \[%\]

  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) \[range: 0-100\]

  From baseline (Day 0) to 3 months after treatment initiation

Secondary Outcomes (3)

• Change in TST misperception after 3 months of daridorexant treatment

  From baseline (Day 0) to 3 months after treatment initiation

• Change in SE misperception after 3 months of daridorexant treatment

  From baseline (Day 0) to 3 months after treatment initiation

• Change in WASO misperception after 3 months of daridorexant treatment

  From baseline (Day 0) to 3 months after treatment initiation

Interventions

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 DRUG

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.

Also known as: Quviviq 50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)
• 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)

You may not qualify if:

• Pregnancy
• Breastfeeding
• Withdrawal of informed consent at any time

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Pisana

Pisa, Pi, 56126, Italy

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Enrica Bonanni, MD, PhD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology - Enrica Bonanni

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 20, 2025
• Study Start: October 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: June 30, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)