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Alaa Almagthali,1 Khalid Al Sulaiman,2– 6 Samiah Alsohimi,7 Kholoud Al Aamer,2,8 Alaa Naser Kurdi,9,10 Alwaleed Nasser Al Qurashi,11 Nawaf Shalih Alqahtani,2 Aljoharah Khaled Alqub,2 Waad A Alnami,12 Abdullah M Alhammad,13 Fatimah Abudayah,14 Ohoud Aljuhani15 1Pharmaceutical Care Department, King Abdulaziz University Hospital, Jeddah, Saudi Arabia; 2Pharmaceutical Care Services, King Abdulaziz Medical City, Riyadh, Saudi Arabia; 3College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia; 4Clinical Trial Management, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia; 5Saudi Critical Care Pharmacy Research (SCAPE) Platform, Riyadh, Saudi Arabia; 6Saudi Society for Multidisciplinary Research, Education, and Development (SCAPE Society), Riyadh, Saudi Arabia; 7Pharmaceutical Care Department, King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia; 8King Abdullah International Medical Research Center, Riyadh, Saudi Arabia; 9Intensive Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia; 10Intensive Care Department, Maternity and Children’s Hospital, Dammam, Saudi Arabia; 11College of Medicine, Taif University, Taif, Saudi Arabia; 12Department of Clinical Pharmacy, King Khalid University, Abha, Saudi Arabia; 13Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia; 14Critical Care Nursing Department, Faculty of Nursing, King Abdulaziz University, Jeddah, Saudi Arabia; 15Department of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi ArabiaCorrespondence: Khalid Al Sulaiman, Pharmaceutical Care Services, King Abdulaziz Medical City, PO Box 22490, Riyadh, 11426, Saudi Arabia, Email alsulaimankh@hotmail.comBackground: Delirium is a frequent complication in critically ill patients and is associated with increased mortality, prolonged hospitalization, and long-term cognitive impairment. Montelukast, a leukotriene receptor antagonist commonly used in respiratory diseases, has been associated with neuropsychiatric adverse effects, including delirium. Evidence regarding its safety in critically ill adults is limited. This study aimed to investigate the association between montelukast use during ICU stay and the development of delirium and further evaluate its safety in the ICU.Methods: This retrospective cohort study was conducted at King Abdulaziz Medical City, Saudi Arabia, between January 2018 and December 2021. Adult critically ill patients (18– 79 years) who were admitted to ICUs for respiratory symptoms and categorized based on montelukast exposure during ICU stay. The primary outcome was assessing the incidence of delirium during ICU stay. Secondary outcomes included delirium duration, recurrence of delirium, delirium-free days, ventilator-free days, length of stay (LOS), safety outcomes (liver and kidney injury), 30-day and in-hospital mortality. Propensity score (PS) matching with a 1:4 ratio was performed to minimize baseline differences between the groups.Results: Out of 1590 screened patients, 1469 were included, and 44 received montelukast during ICU stay. After PS matching (1:4), montelukast use was associated with a significantly higher incidence of delirium (OR 4.66, 95% CI 1.63 to 13.34; P