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Evaluating the Efficacy and Safety of Daridorexant Transition From BZRAs in Insomnia Patients（EASY-TIP）

NCT07733414 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-07-29

No results posted yet for this study

Summary

Brief Summary:

This study is a prospective, multicenter, open-label cohort study designed to evaluate the efficacy and safety of transitioning adult patients with insomnia from benzodiazepine receptor agonists (BZRAs) to daridorexant.

A total of 156 participants will be enrolled. The study consists of a 1-week baseline phase and a 9-week daridorexant treatment phase. During the treatment phase, daridorexant 50 mg is initiated once daily while BZRAs are gradually tapered and discontinued based on individual patient response.

The primary outcome is the proportion of patients who successfully transition from BZRAs to daridorexant at Week 5, defined as a ≥50% reduction or complete discontinuation of the original BZRA dose, with continued willingness to take daridorexant and no withdrawal due to worsening insomnia or adverse events. Secondary outcomes include changes in Insomnia Severity Index (ISI) scores and patient-reported sleep outcomes.

This study aims to provide real-world evidence for the safe and effective transition from BZRAs to daridorexant in clinical practice.

Conditions

  • Insomnia Disorders

Interventions

DRUG

Daridorexant

Daridorexant is a dual orexin receptor antagonist (DORA) supplied as 50 mg film-coated tablets for oral administration. Participants receive 50 mg once nightly, 30 minutes before bedtime, for up to 9 weeks. Dose reduction to 25 mg is permitted based on tolerability. The drug is provided by Jiangsu Simcere Pharmaceutical Co., Ltd.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Zhan · Xuanwu Hospital, Beijing

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-12-01
Completion
2030-12-01

Countries

  • China

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 NCT07733414 on ClinicalTrials.gov