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PURPOSE: Studies suggest that melatonin may prevent delirium, a condition of acute brain dysfunction occurring in 20%-30% of hospitalized older adults that is associated with increased morbidity and mortality. We examined the effect of melatonin on delirium prevention in hospitalized older adults while measuring sleep parameters as a possible underlying mechanism.
METHODS: This was a randomized clinical trial measuring the impact of 3mg of melatonin nightly on incident delirium and both objective and subjective sleep in inpatients age =65years, admitted to internal medicine wards (non-intensive care units). Delirium incidence was measured by bedside nurses using the confusion assessment method. Objective sleep measurements (nighttime sleep duration, total sleep time per 24hours, and sleep fragmentation as determined by average sleep bout length) were obtained via actigraphy. Subjective sleep quality was measured using the Richards Campbell Sleep Questionnaire.
RESULTS: Delirium occurred in 22.2% (8/36) of subjects who received melatonin vs in 9.1% (3/33) who received placebo (P?=?.19). Melatonin did not significantly change objective or subjective sleep measurements. Nighttime sleep duration and total sleep time did not differ between subjects who became delirious vs those who did not, but delirious subjects had more sleep fragmentation (sleep bout length 7.0 ± 3.0vs 9.5 ± 5.3 min; P?=?.03).
CONCLUSIONS: Melatonin given as a nightly dose of 3mg did not prevent delirium in non-intensive care unit hospitalized patients or improve subjective or objective sleep.
This is a randomized trial of 3 mg hs melatonin to prevent delirium in persons 65 and over, cognitively normal at baseline. It is a negative trial possibly by type 2 error, with a small sample size (n=69) and low delirium incidence (15%).
The only limit is the small sample size that leaves the possibility of type II error.
This is a small trial of melatonin in the prevention of hospital-acquired delirium for non-ICU internal medicine patients, one of several similar trials to be published recently. While these results are interesting, this article in isolation is insufficient to warrant practice change.