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NCT07132086
Prospective Observational Study on the Effectiveness of Daridorexant in Chronic Insomnia in a Real-World Setting
trial testing 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 in Insomnia Chronic in 31 participants. Completed in 30 June 2025.
1 March 2025
Quick facts
| Lead sponsor | Azienda Ospedaliero, Universitaria Pisana |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 31 |
| Start date | 1 October 2023 |
| Primary completion | 1 March 2025 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across Italy |
Drugs / interventions 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
Conditions studied
- Insomnia Chronic — all drugs for Insomnia Chronic →
Sponsor
Azienda Ospedaliero, Universitaria Pisana — full company profile →
Who can join
18 and older, any sex, with Insomnia Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07132086
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Azienda Ospedaliero, Universitaria Pisana trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07132086 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Ospedaliero, Universitaria Pisana
- Last refreshed: 20 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07132086.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing