Insomnia
Conditions
Interventions
None listed
Sponsors
Naomasa Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who voluntarily consented to participate in this study. 2) Patients who are 18 years of age or older at the time of consent for this study. 3) Patients diagnosed with insomnia at the research institution and who received their first administration of daridorexant 50 mg between December 2024 and May 2025. 4) Patients for whom the following data are available: - Records confirming the diagnosis of insomnia. - Records of the AIS at the start of daridorexant administration and at the fourth week after initiation (21 to 35 days after administration). 5) Patients with a total AIS score of 6 or higher at the start of daridorexant administration.
Exclusion criteria
Exclusion criteria: 1) Patients who fall under contraindications for, or who are using daridorexant off-label. 2) Patients who are administered daridorexant in a manner inconsistent with described in the package insert. 3) Patients who used other insomnia treatment drugs (medications indicated for insomnia) within 28 days before starting daridorexant administration. This includes patients whose prescription from the referring medical institution contains other medications indicated for the treatment of insomnia within 28 days before starting daridorexant administration. 4) Patients with a history of suicidal ideation, suicide attempts, self-harm, or drug overdose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of AIS from the start of daridorexant administration to the fourth week of administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in QIDS-J and PDQ-D-5 scores from the start of daridorexant administration to the fourth week of administration in insomnia patients with comorbid depression. - Number and frequency of adverse events | — |
Countries
Japan
Contacts
Public ContactTomoko Kubo
EPS Corporation Clinical Research Center Real World Evidence Business Headquarters
Outcome results
None listed