The Effects of Melatonin Supplementation on Sleep Quality and Assessment of the Serum Melatonin in ICU Patients: A Randomized Controlled Trial

Oct 13, 2020Critical care medicine

Melatonin supplements and sleep quality linked to blood melatonin levels in ICU patients

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Abstract

Melatonin treatment resulted in a mean sleep quality score of 69.7 compared to 60.7 for the placebo group.

Patients receiving melatonin reported better sleep quality as assessed by the Richards Campbell Questionnaire.
About 45.8% of patients in the melatonin group experienced very good sleep compared to 34.4% in the placebo group.
A higher percentage of patients in the placebo group reported very poor sleep (14.6%) compared to the melatonin group (3.1%).
Melatonin serum levels peaked at 150 pg/mL in the melatonin group, significantly higher than the 32.5 pg/mL in the placebo group.
No significant differences were found in the prevalence of delirium, pain, anxiety, or the need for analgesics and sedatives between the two groups.

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OBJECTIVES: To evaluate whether the use of exogenous melatonin affects sleep, reduces the prevalence of delirium, and decreases the need for analgosedation and to assess whether serum melatonin indices correlate with exogenous administration in critically ill patients.

DESIGN: Double-blind, randomized, placebo-controlled study.

SETTING: Multicenter ICUs of two tertiary hospitals.

PATIENTS: A total of 203 adult patients who were admitted to the ICU and administered with analgesics and/or sedatives.

INTERVENTIONS: Oral melatonin (10 mg) or placebo for up to seven consecutive nights.

MEASUREMENTS AND MAIN RESULTS: The number of observed sleeping hours at night was assessed by the bedside nurse. Sleep quality was evaluated using the Richards Campbell Questionnaire Sleep (RCSQ). The prevalence of delirium, pain, anxiety, adverse reactions, duration of mechanical ventilation, length of ICU and hospital stays, and doses of sedative and analgesic drugs administered were recorded. The use of analgesics and sedatives was assessed daily. Melatonin levels were determined by enzyme-linked immunosorbent assay. Based on the RCSQ results, sleep quality was assessed to be better in the melatonin group than that in the placebo group with a mean (SD) of 69.7 (21.2) and 60.7 (26.3), respectively (p = 0.029). About 45.8% and 34.4% of participants in the melatonin and placebo groups had very good sleep (risk ratio, 1.33; 95% CI, 0.94-1.89), whereas 3.1% and 14.6% had very poor sleep (risk ratio, 0.21; 95% CI, 0.06-0.71), respectively. No significant difference was observed regarding the days free of analgesics or sedatives, the duration of night sleep, and the occurrence of delirium, pain, and anxiety. Melatonin serum peak levels at 2 AM were 150 pg/mL (range, 125-2,125 pg/mL) in the melatonin group and 32.5 pg/mL (range, 18.5-35 pg/mL) in the placebo group (p < 0.001).

CONCLUSIONS: Melatonin was associated with better sleep quality, which suggests its possible role in the routine care of critically ill patients in the future.

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The Effects of Melatonin Supplementation on Sleep Quality and Assessment of the Serum Melatonin in ICU Patients: A Randomized Controlled Trial

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