Enteral melatonin initiated within 48 h of ICU admission did not reduce the prevalence of delirium compared to placebo. These findings do not support the routine early use of melatonin in the critically ill.

A total of 847 patients were randomized into the study with 841 included in data analysis.

Baseline characteristics of the participants were similar.

There was no significant difference in the average proportion of delirium-free assessments per patient between the melatonin and placebo groups.

There was no significant difference in any secondary outcomes including ICU LOS, hospital LOS, mortality at any time point including at 90 days, nor in the quantity or quality of sleep.

There were no serious adverse events reported in either group.

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