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

Launched by NXERA PHARMA KOREA CO., LTD. · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called Daridorexant to see how well it works and how safe it is for people who have insomnia, which means trouble falling asleep, staying asleep, or waking up too early and not being able to get back to sleep. The goal is to find out if this medicine can help improve sleep quality and quantity for adults who have ongoing sleep difficulties.

Adults aged 19 and older who have been diagnosed with insomnia and feel unhappy with their sleep—such as taking more than 30 minutes to fall asleep, waking up frequently during the night, or sleeping less than about 6.5 hours—might be able to join. People with certain health issues, like very high body weight, sleep apnea, or serious liver problems, would not be eligible. Participants will be closely monitored throughout the study to track how the medicine affects their sleep and to ensure their safety. If you or a loved one struggles with insomnia and are interested, this study may offer an opportunity to try a new treatment under careful medical supervision.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.