insomnia insomnia
Conditions
Interventions
Patients who are scheduled to start receiving daridorexant under routine medical care will be enrolled, have their pre-treatment sleep data collected (using a sleep diary and a wearable device provide
Wearable Devices
Sponsors
ARIYOSHI YU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria at Visit 1 1) Patient who can provide written informed consent voluntarily to participate in this study 2) Japanese male and female patient aged 18 to 65 years at the time of consent 3) Patient who is diagnosed with insomnia in routine medical practice and who will be started on daridrexant 50 mg once daily. 4) Patient with an ISI score of 15 or higher at Visit 1 (indicating moderate to severe insomnia symptoms) 5) Patient who can continue from Visit 1 to Visit 2 without changing the ongoing treatment for insomnia if already receiving treatment 6) Patient whose with a bedtime between 22:00 and 01:00 7) Patient who is able to wear a wearable device during sleep throughout the study period 8) Patient who can comply with the study protocol as outlined in the study plan Inclusion Criteria at Visit 2 1) Patient with an ISI score of 15 or more at Visit 2 2) Patient with at least 5 days of recorded data from both wearable devices and sleep diaries during the pre-treatment sleep data collection period (Patient with wearable device recorded for at least 3 days are accepted.) 3) Patient whose sleep diary reports show bedtimes between 22:00 and 01:00 on at least 5 days during the pre-treatment sleep data collection period 4) Patient whose sleep diary reports indicate time in bed (from bedtime to wake time) of at least 6 hours on at least 5 days during the pre-treatment sleep data collection period
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Visit 1 1) Patient for whom daridorexant is contraindicated or being prescribed off-label 2) Patient who have previously taken daridorexant, experienced insufficient effectiveness or tolerance issues, and discontinued treatment 3) Patient taking three or more drugs for insomnia at Visit 1 (including constant use) 4) Patient taking two drugs for insomnia at Visit 1, with the investigator determining that it is not appropriate to discontinue any of the medications to participate in this study 5) Patient who works at night 6) Patient whose time in bed (from bedtime to wake-up time) is less than 6 hours 7) Patient who plans to travel abroad with a time difference of 4 hours or more during the study period 8) Patient with a history of suicidal ideation, suicide attempts, self-harm, or drug overdose 9) Patient who is deemed by the principal investigator (subinvestigator) to have acute or unstable comorbid psychiatric disorders (anxiety disorder, major depression, bipolar disorder, schizophrenia, obsessive-compulsive disorder, etc.) that may affect the safety and evaluation of daridorexant. 10) Patient with a history of or comorbidity with severe sleep apnea syndrome (AHI>30) 11) Patient diagnosed with alcohol dependence within two years or who cannot abstain from alcohol for more than three consecutive days 12) Patient who is unable to abstain from smoking between two hours before bedtime and wake-up time 13) Patient who is deemed inappropriate for participation in this study by the principal investigator (subinvestigator) Exclusion Criteria for Visit 2 1) Patient whose insomnia medication and dosage were changed between Visit 1 and Visit 2 2) Patient who were taking two insomnia medications at Visit 1, and as judged by the principal investigator (subinvestigator), deemed unable to discontinue any of the medications to start daridorexant administration from Visit 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ISI total score from Visit 2 to Visit 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in ISI total score from Visit 2 to Visit 4 2) Change in ISI item scores from Visit 2 to Visit 4 and Visit 5 | — |
Contacts
Public ContactYU ARIYOSHI
YOU ARIYOSHI SLEEP CLINIC
Outcome results
None listed