97
Participants
Start Date
March 24, 2021
Primary Completion Date
June 20, 2022
Study Completion Date
June 20, 2022
Lemborexant (LEM) 5 mg (Z-Drug-mono cohort)
"1. Pretreatment phase: Continue pre-registration treatment (Z-drug monotherapy) without LEM.~2. First treatment phase: Administer LEM 5 mg/day as a substitute for Z-Drug. Increasing LEM dose to 10 mg/day is allowed.~3. Maintenance phase: Succeed the treatment from the first treatment phase. Changing LEM dose is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition."
Lemborexant (LEM) 5 mg (SUV-mono cohort)
"1. Pretreatment phase: Continue pre-registration treatment (SUV monotherapy) without LEM.~2. First treatment phase: Administer LEM 5 mg/day as a substitute for SUV. Increasing to LEM dose to 10 mg/day is allowed.~3. Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed."
Lemborexant (LEM) 5 mg (SUV-combination cohort)
"1. Pretreatment phase: Continue pre-registration treatment (SUV and BZRA combination therapy) without LEM.~2. First treatment phase: Administer LEM 5 mg/day as a substitute for SUV and continue BZRA. Increasing to LEM dose to 10 mg/day is allowed.~3. Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed. Decreasing dose or discontinuation of BZRA is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition."
Lemborexant (LEM) 5 mg (RMT-combination cohort)
"1. Pretreatment phase: Continue pre-registration treatment (RMT and BZRA combination therapy) without LEM.~2. First treatment phase: Administer LEM 5 mg/day as a substitute for RMT and continue BZRA. Increasing to LEM dose to 10 mg/day is allowed.~3. Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed. Decreasing dose or discontinuation of BZRA is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition."
YOU ARIYOSHI Sleep Clinic, Kitakyushu
Kurume University Hospital, Kurume
Hirota Clinic, Kurume
Kurume University Medical Center, Kurume
Kotorii Isahaya Hospital, Isahaya
Ohshima Hospital, Nakatsukuma
Sleep Support Clinic, Shinagawa
Sleep & Stress Clinic, Shinagawa
Kuwamizu Hospital, Kumamoto
Collaborators (1)
Eisai Inc.
INDUSTRY
Mebix Inc
INDUSTRY
Kurume University
OTHER