Agomelatine for the Treatment of Generalized Anxiety Disorder

Relevance. Given the prevalence of generalized anxiety disorder (GAD) as well as the functional impairment and maladaptation it causes, there is still a need for further development of methods of long-term effective pharmacotherapy with good tolerability. This article aimed to analyze literature data on the effectiveness and tolerability of agomelatine in the treatment of GAD. Materials and methods. Search and analysis of articles published between 2005-2024 years was conducted in PubMed and eLIBRARY databases. Results. Data from randomized controlled trials and meta-analyses indicate that agomelatine is highly effective for both relief and long-term anti-relapse treatment of GAD. Agomelatine is effective against both groups of anxiety symptoms, especially somatic ones. The highest efficacy of agomelatine was established in a subpopulation of patients with the most severe GAD (HARS ≥ 25, CGI-S ≥ 5). The tolerability of agomelatine is equivalent to that of placebo, without the occurrence of withdrawal symptoms and sexual dysfunction. Conclusion. The registration of a new indication for agomelatine opens new prospects for the improvement of effectiveness and tolerability of GAD therapy. © 2025 Elsevier B.V., All rights reserved.