Profile of agomelatine and its potential in the treatment of generalized anxiety disorder

BACKGROUND: Although many generalized anxiety disorder (GAD) patients respond to the available pharmacological treatments, nearly half of them do not present the expected results. Besides, the side effects associated to some drugs have a negative impact on treatment adherence. Therefore, the aim of this review was to report the clinical profile of agomelatine, a selective melatonergic MT(1)/MT(2) receptor agonist with serotonin 5-HT(2c) receptor antagonist activities, as a potential pharmacological option in the treatment of GAD. METHODS: We performed a literature review regarding studies that evaluated the use of agomelatine in GAD treatment. RESULTS: Two short-term, double-blinded studies and one prevention-treatment trial evaluated the efficacy of agomelatine in the treatment of GAD. Agomelatine was associated with higher rates of clinical response and remission, when compared to placebo. In addition, the long-term use of agomelatine decreased the risk of relapse of anxiety symptoms, even for the severely ill patients. Besides, the tolerability was satisfactory with the absence of discontinuation symptoms, as observed in previous studies. CONCLUSION: The efficacy and tolerability profiles of agomelatine in the treatment of GAD were good. However, the scarce number of trials, the small sample sizes, and the use of patients without any comorbid conditions were some limitations that impaired the generalization of the results in the general population. Nevertheless, agomelatine is an attractive off-label option in the treatment of GAD that needs more conclusive evidences to establish its role in future guidelines.