INDICATION

Major depressive disorder in adults especially in non-responders and intolerant to SSRIs including prevention of relapse

DOSAGE & ADMINISTRATION

Dose: The effective dose of agomelatine is 25 mg per day given once at bed time for two weeks and can be increased to 50 mg per day in patients with inadequate response. Night time dosing is recommended because agomelatine improves the quality of sleep without day time sedation.

Administration: For oral administration with or without food. Most adult patients should take a dosage of 25 mg (one tablet) daily. It is usually taking prior to bed time. If no improvement is noticed after two weeks, the dosage can be increased to 50 mg (two tablets) daily. 

Children under 18 years: Should be given only on medical advice. 

Use in children and adolescents: Agomelatine is not recommended in the treatment of depression in patients <18 years since safety and efficacy of agomelatine have not been established in this age group. In clinical trials among children and adolescents treated with other antidepressants, suicide-related behavior (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behavior and anger) were more frequently observed compared to those treated with placebo.

Use in the elderly: The efficacy and safety of agomelatine (25 to 50 mg/day) have been established in elderly patients with MDD (aged <75 years). As efficacy has not been established in every elder patients aged ≥75 years agomelatine should not be used in this patient group .
 

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