A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder

NCT07028697 | Completed Phase 3

• 1 other identifier: NPK-DAR-301
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this phase 3 study is to evaluate the efficacy and safety of Daridorexant compared to in participants with insomnia disorder.

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

• Subjective total sleep time(sTST)

  Change from baseline to week 4 in subjective total sleep time (sTST) measured by eDairy

  Week 4

Secondary Outcomes (2)

• Subjective latency to sleep onset (sLSO)

  Week 4

• Subjective wake after sleep onset (WASO)

  Week 4

Study Arms (2)

Daridorexant

EXPERIMENTAL

Drug: Daridorexant

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Daridorexant DRUG

Daridorexant will be taken orally, once daily in the evening as indicated by investigator.

Daridorexant

Placebo DRUG

Placebo will be taken orally, once daily in the evening as indicated by investigator.

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study-mandated procedure;
• Male or female aged ≥ 19 years;
• Insomnia disorder according to DSM-5 criteria;
• The predominant complaint is dissatisfaction with sleep quantity or quality, associated with one (or more) of the following symptoms:
• Difficulty initiating sleep.
• Difficulty maintaining sleep (characterized by frequent awakenings or problems returning to sleep after awakenings).
• Early-morning awakening with inability to return to sleep.
• Insomnia Severity Index score ≥ 15;
• Insufficient sleep quantity as collected subjectively in the sleep diary A. ≥ 30 min to fall asleep, and B. Wake time during sleep ≥ 30 min, and C. Subjective Total Sleep Time (sTST) ≤ 6.5 h

You may not qualify if:

• Body mass index (BMI) ≥ 40.0 kg/m2
• Documented medical history and/or comorbidity of sleep-related breathing disorder
• History of and/or concurrent sleep apnea or suspected sleep apnea
• Korean-Mini Mental State Examination-2 (K-MMSE-2) score \< 25 in subjects ≥ 50 years;
• For female subjects: pregnant, lactating or childbearing potential who do not consent to true abstinence or use an effective method of contraception for required period
• Initiation of the cognitive behavior therapy (CBT) for treatment of insomnia disorder within 4 weeks prior to the Screening visit (Visit 1) or planned CBT during the study
• A history of moderate to severe hepatic impairment (eg, Child-Pugh Class B or C)
• Positive urine drug test or presence of alcohol in exhaled breath as detected by breathalyzer test.

Sponsors & Collaborators

• Nxera Pharma Korea Co., Ltd.: lead

Study Sites (17)

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Pusan National University Yangsan Hospital

Busan, 50612, South Korea

Location

Soonchunhyang University Cheonan Hospital

Cheonan, 31151, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, 42601, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, 10380, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Catholic Kwandong University International St. Mary'S Hospital

Incheon, 22711, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Kyung Hee University Hospital At Gangdong

Seoul, 05278, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Ewha Womans University Medical Center

Seoul, 07804, South Korea

Location

The Catholic University of Korea, ST. Vincent's Hospital

Suwon, 16247, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

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

• Clinical Development, Nxera Pharma Korea Co., Ltd.

  Nxera Pharma Korea Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: December 4, 2024
• Primary Completion: September 23, 2025
• Study Completion: October 21, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

KR (17)