Navigating sensorium: Lemborexant vs. melatonin vs. placebo for management of delirium – a hospital-based, single-center, parallel, double blinded, randomized controlled trial

This study will be a prospective, hospital-based, placebo-controlled, double- blind, three-arm, parallel randomized control trial. All the participants with delirium will be screened and those meeting the preset inclusion and exclusion criteria will be included in the study. Sociodemographic information, clinical data, and scores on the Memorial Delirium Assessment Scale (MDAS), Charlson Comorbidity Index (CCI), and Anticholinergic Burden Score (ABC) will be collected at baseline. After randomisation patient will be assigned to either Group A (lemborexant) or Group B (melatonin) or Group C (placebo group).

The starting dose for both lemborexant and melatonin at baseline would be one oral tablet of 5mg. Similarly, patients receiving placebo will be given one tablet initially. All subjects will be continuously monitored. Relevant clinical data and scores on the MDAS, CCI and ABC will be recollected on the 4th day and 8th day from baseline. In those with persistent delirium on the 4th day, the dose will be increased to 2 tablets or 10mg of either drug. Similarly, in patients receiving placebo dose will be increased to 2 tablets. A record of any adverse events will be maintained throughout the study period. The primary outcome measure of this study will be the change in MDAS scores from baseline to the 4th and 8th days. The secondary outcome measures of this study will be all cause mortality by the 8th day, and length of delirium.