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Expert Opin Investig Drugs. 2014 Jun;23(6):857-64. doi: 10.1517/13543784.2014.911840. Epub 2014 Apr 28.

Agomelatine in treating generalized anxiety disorder.

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  • 1University Psychiatric Center KU Leuven, campus Gasthuisberg , Herestraat 49, 3000 Leuven , Belgium



Generalized anxiety disorder (GAD) is a chronic and disabling disorder with a lifetime prevalence of 4.3 - 5.9% in the general population. Many drug and non-drug treatments have been shown to be effective in the treatment of GAD, including benzodiazepines, antidepressants (selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors and tricyclic antidepressants), anticonvulsants, azapirones, antihistamines, atypical antipsychotics, complementary/alternative medicine, psychotherapy and Internet-based services. Agomelatine is an antidepressant approved by the European Agency; it is a melatonergic agonist (MT1 and MT2 receptors) and a 5-HT2C antagonist indicated in the treatment of major depressive episodes.


The present article looks at the short-term efficacy of Agomelatine assessed in two short-term placebo-controlled studies. It also looks at the long-term efficacy evaluated in one relapse prevention study.


Agomelatine is an effective treatment option for both GAD and somatic anxiety. The trial, which includes an escitalopram arm, shows comparable efficacy in GAD between both antidepressants, whereas the restoration of sleep was significantly better with agomelatine. The low discontinuation rate illustrates the good tolerability and lab results show a low incidence of transient elevations in liver enzymes. Whereas uptitrated patients on a 50 mg dose have a lower chance of reaching the desired outcome than the lower 25 mg dose, those reaching this outcome have a better chance of treatment continuation.


agomelatine; generalized anxiety disorder

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