background Sleep disorders are a frequent problem with an important impact on the quality of life. Given its physiological properties, melatonin is often associated with sleep disorders and their treatment. In addition, melatonin has been recognized by the European Medicines Agency (ema) since 2007 for primary insomnia in adults over 55 years of age for a maximum of 13 weeks.
aim Analysis of the international literature on the indication statements and effectiveness of melatonin for sleep disorders and their testing against practical use.
method A narrative literature study in PubMed, Cochrane and Web of Science, supplemented with a retrospective study of prescribing behavior within a university psychiatric hospital.
results The current evidence for the use of melatonin for insomnia and circadian arrhythmias is low. We also noted that the effectiveness of melatonin for the recognized indication of primary insomnia was questioned by some guidelines and that the various studies were also heterogeneous in terms of outcome measures, indication statements and formulated advice. In addition, only 19.6% of the requirements in the retrospective study met the official ema indication.
conclusion This study shows that melatonin is mainly used off-label. Overall, there appears to be limited effectiveness of melatonin, which has an impact on the indication statements.