Efficacy of melatonin in the treatment of insomnia: a systematic review of clinical trials
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Abstract
Insomnia designates the difficulty in falling or staying asleep, waking up earlier than needed or having a non-refreshing sleep. It includes both circadian rhythm sleep-wake disorders (e.g. delayed sleep phase syndrome or shift work sleep disorder) and non-REM sleep arousal disorders (somnambulism, sleep terrors or nightmares, among others). The most used drugs for insomnia (benzodiazepines and Z-hypnotics) produce many adverse effects and are not recommended for long-term use. Therefore, alternatives presumably showing better safety and same effectiveness have been commercialized, e.g. melatonin. Recently, the use of melatonin to alleviate any type of insomnia in patients of all ages has greatly increased, but it is unclear whether its use is evidence-based. Thus, the aim of this work was to evaluate the efficacy of melatonin to alleviate primary insomnia in patients of all ages by conducting a systematic review of placebo-controlled clinical trials. Melatonin (2 mg, 3 weeks) is effective in primary insomnia to shorten sleep latency and to improve sleep quality, wellness and quality of life. Nevertheless, few trials address specific types of insomnia. Studies show that melatonin is effective to alleviate insomnia in patients older than 55 years. However, only one trial has been conducted in patients under 55 years old. We conclude that melatonin (2 mg, 3 weeks) is effective in patients older than 55 years to alleviate primary insomnia, but its use in younger patients, at smaller doses or in other types of insomnia is not evidence-based.
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