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Melatonin - the most well studied factor of the circadian rhythm - attracts much intereset in regard to a disease-modifying therapy for epilepsy. In some forms of epilepsy, circadian dysrhythmias and sleep disorders can trigger the development of epileptic seizures, while in others - seizures develop from the REM-phase of sleep. The aim is to review and analyze studies on the efficacy and safety of exogenous melatonin as an additional medication for disease-modifying therapy in pediatric and adult patients with epilepsy. Materials and methods . The search was conducted for Russian and English articles reflecting the results of studies on the efficacy and safety of exogenous melatonin in patients with epilepsy. We used the following databases: ELibrary.ru, Web of Science, Scopus, Clinical Case, PubMed, Cochrane Database of Systematic Reviews. The search was carried out using the keywords: melatonin, epilepsy, epileptic syndrome, disease-modifying therapy, children, adolescents, adults, safety, efficacy, reduction of seizures, adverse drug reactions, quality of life. The following materials were included in the search: full-text articles in Russian and English; original research papers; Cochrane reviews; clinical observations; publication dates - from 2003 to 2018. We did not reviwed: abstracts; theses; monographs; handbooks; textbooks; materials published before 2003. In total we found 986 publications; of those, 114 met the inclusion criteria. Results. Clinical studies on the efficacy and safety of exogenous melatonin in a disease-modifying therapy for epilepsy in children and adults are rare, conducted in small groups of patients, and differ in their design. These findings do not allow recommending melatonin, at the present time, for widespread use in the routine clinical treatment of epilepsia. Notably, determining the optimal daily dose of exogenous melatonin is rather difficult because this drug has both proconvulsive and anticonvulsant effects. Therefore, such a disease-modifying therapy requires a personalized approach to achieve a balance between these two actions of melatonin. Conclusion. The role of exogenous melatonin as a treatment modality in epilepsy remains unclear, although this approach is considered possible for disease-modifying therapy. Large-scale clinical studies on the efficacy and safety of exogenous melatonin in epilepsy are needed. Currently, the use of exogenous melatonin in epilepsy is not regulated by law.

Exogenous melatonin as a disease-modifying therapy for epilepsy