Valdoxan (agomelatine) is approved in treatment of moderate to severe depression in adults. The drug acts by stimulating the excretion of melatonine and increasing the serotonine concentration.
Short term studies show that agomelatine (6-8 weeks) has a significant better effect on depression than placebo after 2 weeks in proportion to a decrease in the depression scale HAMD. But it is difficult to compare the effect of agomelatine with other antidepressants, because remission of the depressions has not been a primary endpoint. There has not been shown any dose-response correlations. On the other hand, one of two long term studies has shown a lower risk for relapse in advantage of agomelatine.
The side effects are few and transient. Because of the risk of elevated liver enzymes, it is discouraged to combine Valdoxane with alcohol consumption. There are significant fewer sexual side effects in depressive women (regarding orgasm dysfunction), and in healthy men.
The low dose of 25 mg has fewer discontinuation symptoms than paroxetine (20 mg), but it is unknown whether the same applies for a dose of 50 mg. Agomelatine has shown marginally better sleeping patterns regarding improved sleep compared to venlafaxine (Efexor) and sertraline (Zoloft). The clinical relevance of this, however, is questionable.
Because of increased mortality among patients with dementia, this group should not be treated with agomelatine. Agomelatine has not shown any effect in elderly.
Valdoxan (agomelatine) costs 14,78 DKr for a daily dose of 25 mg. Some patients may need 50 mg, if 25 mg is inadequate, thus giving a daily price of 29,56 Dkr. This is not known in the beginning of the treatment, but will be found out after a couple of weeks. In comparison, the cheapest venlafaxine costs 1 -2 Dkr at the moment, dependent on the dose (75-150 mg), while citalopram and sertraline cost approximately 0,19-0,39 Dkr for a daily dose (20 mg).
IRF still states, that the SSRI’s citalopram and sertraline are the drugs of first choice in treatment of depression, and thereafter - depending of dose and thus price – other drugs, e.g. SNRI or likewise, can be used. If sleeping problems are a pronounced problem in depression, mirtazapine (0,37 Dkr per day) can be considered. Agomelatine can be tried if the patient is very bothered by side effects when treated with one of the other antidepressants, but the effect should at the moment be considered as marginal. Furthermore, the optimum dose has not yet been determined.
Valdoxan was marketed on June 15th, 2009. This article has been updated on February 15th, 2010, as a result of new studies. There is general reimbursement.
Institute for Rationel Pharmacotherapy, July 13th, 2009.
Updated February 15th, 2010.