60
Participants
Start Date
May 1, 2025
Primary Completion Date
April 30, 2027
Study Completion Date
April 30, 2027
Lemborexant 5 mg
"The intervention is the oral administration of a study drug containing lemborexant 5 mg daily between 2000h and 0000h for the first 7 days following extubating/initiation criteria is met or until their hospital discharge or until the first diagnosis of delirium, whichever occurs first.~Initiation criteria:~I. The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for \>1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of \>-1 or a Pasero Opioid-induced Sedation Scale (POSS) score \<3.~If satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score \<50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement.~If participants develop delirium, the study drug will be discontinued."
Control (placebo) group
"The control group will receive an oral placebo tablet daily between 2000h and 0000h for the first 7 days following when initiation criteria is met or until their hospital discharge, whichever occurs first.~Initiation criteria:~I. The participant has been extubated for at least 2 hours II. all other sedative medications have been discontinued for \>1 hour III. the participant has a Richmond Agitation and Sedation Scale (RASS) score of \>-1 or a Pasero Opioid-induced Sedation Scale (POSS) score \<3.~If satisfactory sleep is not achieved with the 5 mg dose of the study drug, as defined by a Richards Campbell Sleep Score \<50 within 1 hour, another insomnia medication may be administered on participant request and clinician judgement.~If participants develop delirium, the study drug will be discontinued."
St. Paul's Hospital, Vancouver
Eisai Inc.
INDUSTRY
Providence Health Care, British Columbia
UNKNOWN
St. Paul's Hospital, Vancouver (Providence Health Care)
UNKNOWN
University of British Columbia
OTHER