General Information

Remeron (mirtazapine) is an antidepressant. 

Remeron is specifically indicated for the treatment of major depressive disorder (MDD) in adults.

Remeron is available as tablets, for oral use.  An orally disintegrating tablet formulation is also available as RemeronSolTab. 

The recommended starting dose of Remeron/RemeronSolTab is 15 mg once daily, administered orally, preferably in the evening prior to sleep. If patients do not have an adequate response to the initial 15 mg dose, increase the dose up to a maximum of 45 mg per day. Dose changes should not be made in intervals of less than 1 to 2 weeks to allow sufficient time for evaluation of response to a given dose.

Mechanism of Action

Remeron (mirtazapine) is an antidepressant. The mechanism of action of mirtazapine for the treatment of major depressive disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α2- adrenergic inhibitory autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.

Side Effects

Adverse effects associated with the use of Remeron/RemeronSolTab may include, but are not limited to, the following:

• somnolence
• increased appetite
• weight gain
• dizziness

Clinical Trial Results

The effectiveness of Remeron Tablets as a treatment for depression was established in four placebo-controlled, 6-week trials in adult outpatients. Patients received mirtazapine from a dose range of 5 mg up to 35 mg per day. Overall, these studies demonstrated mirtazapine to be superior to placebo on at least three of the following four measures: 21-Item Hamilton Depression Rating Scale (HDRS) total score; HDRS Depressed Mood Item; CGI Severity score; and Montgomery and Asberg Depression Rating Scale (MADRS). Mirtazapine was also shown to be superior to placebo for certain factors of the HDRS, such as anxiety/somatization and sleep disturbance. 

In a longer-term study, patients meeting (DSM-IV) criteria for major depressive disorder who had responded during an initial 8 to 12 weeks of acute treatment on Remeron were randomized to continuation of Remeron or placebo for up to 40 weeks of observation for relapse. Response during the open phase was defined as having achieved a HAM-D 17 total score of ≤8 and a CGI-Improvement score of 1 or 2 at 2 consecutive visits beginning with week 6 of the 8 to 12 weeks in the open-label phase of the study. Relapse during the double-blind phase was determined by the individual investigators. Patients receiving continued Remeron treatment experienced significantly lower relapse rates over the subsequent 40 weeks compared to those receiving placebo. This pattern was demonstrated in both male and female patients.