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

NCT07132086 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2025-08-20

No results posted yet for this study

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

Interventions

DRUG

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

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.

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    lead OTHER

Principal Investigators

  • Enrica Bonanni, MD, PhD · University of Pisa

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-03-01
Completion
2025-06-30
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07132086 on ClinicalTrials.gov