Abstract
Agomelatine is an antidepressant with a new mechanism of action. It acts as a melatonergic agonist (MT1, MT2 receptors) and 5-HT2C serotonergic antagonist.
Acting on these receptors resynchronizes circadian rhythms and has antidepressant effects. Efficacy and safety of agomelatine has been evaluated in several clinical trials, where it was compared with placebo and active comparators.
Its antidepressant efficacy, even in cases of severe depression, was demonstrated in studies with placebo and with direct comparisons to other antidepressants (venlafaxine, sertraline, fluoxetine, escitalopram). Clinical studies also revealed anxiolytic efficacy of agomelatine and beneficial effects on the quality of sleep.
An important benefit of agomelatine is a fast onset of action observed within the first 2 weeks of treatment, and an excellent tolerability profile without weight gain and sexual dysfunction. Agomelatine is potent even during a prolonged use, showing a high proportion of adherent patients.
The European Medicines Agency (EMA) registered agomelatine for its use in the European Union in February 2009. It is indicated for the treatment of depressive episodes in adults, 25 mg administered once daily at bedtime.
The recommended duration of treatment, as with all antidepressants, is at least 6 months. Agomelatine has a very good tolerability and low rate of side effects.
Stopping agomelatine treatment is not accompanied by withdrawal symptoms, and therefore does not require a gradual tapering. Agomelatine should not be used in severe hepatic impairment.
It is recommended to monitor liver function during the treatment of all patients. Agomelatine treatment must be discontinued if aminotransferase activity increases to more than three times of the upper limit of normal range.
Agomelatine can be safely combined with other drugs except for fluvoxamine and ciprofloxacin. If treated with agomelatine, nursing mothers should stop breast feeding.
In recent years, several large observational studies confirmed the efficacy and safety of agomelatine in routine clinical practice. About 2 million patients worldwide have taken agomelatine already