ICU sedation, delirium & recovery

Melatonin and delirium in the intensive care units: a systematic review and meta-analysis of randomized controlled trials

Intensive Care MedPublished Systematic review and meta-analysis of randomised controlled trials

Pooled result · Low to moderate risk of bias trialsResult — go to the resultRelative risk 0.89 95% CI 0.73–1.09

Authors' conclusion

The results suggest that compared to placebo, melatonin does not reduce delirium incidence in critically ill patients. Similarly, no effect was observed on mortality.

Study context

Population
Critically ill patients in the ICU
Participants
2,209 patients · 6 randomized controlled trials (RCTs)
Comparison
Melatonin vs placebo
Outcome
Incidence of delirium
Methodological detailsprimary analysis restricted to trials with low to moderate risk of bias
  • Primary analysis restricted to trials with low to moderate risk of bias

Pooled result

Low to moderate risk of bias trials

Relative risk

0.89

95% CI 0.73–1.09

Melatonin vs Placebo
RR 0.89 (95% CI 0.73–1.09)

As reported in the abstract

Further pooled results

OutcomeRR (95% CI)
Incidence of delirium, all trials (secondary analysis)13 RCTs, 2830 patients0.86 (0.70–1.04)
Mortality (primary analysis)7 RCTs, 2165 patients0.87 (0.73–1.02)
Mortality (secondary analysis)8 RCTs, 2396 patients0.92 (0.79–1.06)

Original publication

Melatonin and delirium in the intensive care units: a systematic review and meta-analysis of randomized controlled trials. Intensive Care Med. Published 6 October 2025. doi:10.1007/s00134-025-08143-1

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