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

Sponsor
Azienda Ospedaliero, Universitaria Pisana
Study ID
NCT07132086
Status
Completed

Conditions

  • Insomnia Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Aug 2025
Primary completion
Mar 1, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
31 participants (actual)

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 ]

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