Efficacy and Safety of Sustained-Release Melatonin Capsules (2 mg) in Healthy Adults with Poor Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Trial
Abstract
Sleep disturbances and poor sleep quality are growing public health concerns, adversely affecting both physical and mental health. While exogenous melatonin supplements are used to manage the condition, there is limited evidence available on the efficacy of sustained-release (SR) melatonin formulations. This multicenter, randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of melatonin-SR capsules (2 mg) in healthy adults with poor sleep quality. Participants aged 30–60 years with poor sleep quality received melatonin-SR (2 mg) or a placebo capsule at night for 28 days. Changes from baseline to day 28 in polysomnography (PSG)-derived sleep parameters, Pittsburgh Sleep Quality Index (PSQI), WHO-5 Well-Being Index, sleep diary parameters, and safety profile were evaluated. Of 62 enrolled participants, 59 (melatonin-SR, n = 28; placebo, n = 31) completed the study. Compared with placebo, melatonin-SR supplementation resulted in significant improvements at day 28 in PSG-derived sleep efficiency (change from baseline: 3.49 for melatonin-SR vs. −6.30% for placebo; p = 0.001) and total sleep time (change from baseline: 23.83 for melatonin-SR vs. −39.25 min for placebo; p = 0.001), along with significant reductions in sleep onset latency (change from baseline: −10.28 for melatonin-SR vs. 16.70 min for placebo; p = 0.031) and wake after sleep onset (change from baseline: −14.92 for melatonin-SR vs. 24.71 min for placebo; p = 0.001).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 62 participants or records.
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