The Midlands Therapeutics Review and Advisory Committee has issued advice for doctors in the West Midlands that melatonin 2mg controlled release (Circadin®) cannot be recommended due to inadequate evidence of efficacy or safety.
The review identified two randomised controlled trials that compared melatonin to placebo. No trials were identified that used active comparators.
These two trials collected primary data on subjective improvements in sleep scored using the Leeds Sleep Evaluation Questionnaire. Duration of sleep and latency of sleep were analysed as secondary outcomes.
Overall, the results did show some subjective benefit but the effect size was small. Clinically significant improvements in sleep scores were apparent from 14% of placebo users compared to 25% of melatonin users. It was also found that participants in the active treatment arm did not sleep for longer but did get to sleep 9 minutes earlier than patients taking placebo; this difference was statistically significant but the clinical significance remains in doubt.
Action: Clinicians will find that this review is a useful summary of the available data. This drug should not be in routine use due to the lack of comparative data versus existing treatments.
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