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

NCT07733414 | Not Yet Recruiting Phase 4

• 1 other identifier: CNS-DARI-IS_002
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Insomnia Disorder; Daridorexant; BZRAs; Drug Transition

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Successfully Transitioning 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 at Week 5 (Visit 5, Day 42 ± 3 days).

  At Week 5 (Visit 5, Day 42 ± 3 days)

Study Arms (1)

Daridorexant Transition Group

EXPERIMENTAL

Participants receive daridorexant 50 mg orally once nightly for 9 weeks, with gradual tapering and discontinuation of their prior benzodiazepine receptor agonist (BZRA) therapy based on individual clinical response. Dose reduction of daridorexant to 25 mg is permitted if clinically indicated. The study includes 6 visits over 10 weeks, with the primary endpoint assessed at Week 5.

Drug: Daridorexant

Interventions

Daridorexant DRUG

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.

Also known as: Quviciq

Daridorexant Transition Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥18 and ≤70 years.
• Meet DSM-5 diagnostic criteria for insomnia disorder: dissatisfaction with nighttime sleep despite adequate sleep opportunity, manifested as difficulty initiating sleep, difficulty maintaining sleep (frequent awakenings or difficulty returning to sleep after awakening), or early-morning awakening with inability to resume sleep, accompanied by subjective experience of daytime dysfunction. Symptoms occur ≥3 times per week and persist for ≥3 months.
• Received stable BZRA monotherapy for at least 3 nights per week during the 1 month prior to enrollment.
• Bedtime duration of no less than 7 hours per night.
• Unsatisfactory response or intolerance to current therapy, with clinical need to adjust insomnia medication regimen.
• Hamilton Anxiety Rating Scale (HAMA-14) score \<14.
• Hamilton Depression Rating Scale (HAMD-17) score \<17.
• Willing and able to comply with the study protocol and provide written informed consent.

You may not qualify if:

• History of chronic insomnia \>5 years.
• Other sleep disorders such as narcolepsy-related symptoms, restless legs syndrome, circadian rhythm sleep disorder, REM sleep behavior disorder, etc.
• Daytime napping ≥1 hour/day and ≥3 days/week.
• Daily BZRA dose exceeding the maximum recommended dose for insomnia treatment per package insert.
• BZRA use \>5 nights per week.
• History of BZRA treatment ≥3 years.
• Concurrent use of two or more BZRAs within the past 3 months.
• Use of central nervous system depressants within the past 3 months.
• Use of long-acting sedative-hypnotics (e.g., clonazepam) within the past 3 months.
• Use of anxiolytics or antidepressants for off-label insomnia treatment within the past 3 months.
• Initiation of cognitive behavioral therapy for insomnia (CBT-I) within 1 month prior to Visit 1.
• Prior non-response to orexin receptor antagonists (daridorexant, lemborexant, suvorexant, etc.).
• Clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal) that may affect participant safety or interfere with study assessments, as judged by the investigator. Participants for whom sedative medications are contraindicated due to occupational or safety reasons are also excluded.
• Severe psychiatric disorder within the past 6 months, or severe alcohol/substance abuse/dependence within the past 2 years.
• Active suicidal ideation or behavior within the past 6 months.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 10053, China

Location

Related Publications (2)

• Roch C, Bergamini G, Steiner MA, Clozel M. Nonclinical pharmacology of daridorexant: a new dual orexin receptor antagonist for the treatment of insomnia. Psychopharmacology (Berl). 2021 Oct;238(10):2693-2708. doi: 10.1007/s00213-021-05954-0. Epub 2021 Aug 20.

  PMID: 34415378 BACKGROUND

• Treiber A, de Kanter R, Roch C, Gatfield J, Boss C, von Raumer M, Schindelholz B, Muehlan C, van Gerven J, Jenck F. The Use of Physiology-Based Pharmacokinetic and Pharmacodynamic Modeling in the Discovery of the Dual Orexin Receptor Antagonist ACT-541468. J Pharmacol Exp Ther. 2017 Sep;362(3):489-503. doi: 10.1124/jpet.117.241596. Epub 2017 Jun 29.

  PMID: 28663311 BACKGROUND

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

• Zhan

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo

CONTACT

025-85566666; guojingjing@simcere.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)