A review of preliminary observations on agomelatine in the treatment of anxiety disorders.

Agomelatine is an antidepressant with a novel mechanism of being a selective melatonergic MT₁/MT₂ receptor agonist with serotonin 5-HT(2c) receptor antagonist activities. Although the vast majority of the clinical data concerning the effectiveness of agomelatine concern its antidepressant properties, there is also preliminary evidence of anxiolytic effects. The purpose of the study was to perform a review of studies that investigated the efficacy of agomelatine in the treatment of anxiety disorders (ADs) and a discussion of the clinical utility of agomelatine in this clinical population. Previous clinical data indicated that agomelatine was more efficacious than both placebo and comparator drugs in reducing anxiety symptoms in depressed patients. Moreover, agomelatine effectiveness in the treatment of AD patients was observed in 2 double-blind, randomized trials, in a case series and in 3 case reports. Greater clinical evidence was observed with generalized AD patients. Agomelatine was efficacious both in reducing anxiety symptoms and in preventing relapses after a 6-month follow-up. However, concerning other ADs, evidence of agomelatine's effects on anxiety was found only in isolated case descriptions. Nevertheless, those case reports emphasized the drug's favorable side effect profile (in comparison to serotonin reuptake inhibitors) and its effectiveness in treatment-refractory patients. Considering the high incidence of poor efficacy and tolerability of the first-line agents in the treatment of ADs, agomelatine seems to be a promising option in cases of treatment failure, and it could be used as a second or third option, as monotherapy or as augmentation treatment.