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Clinical Trials

Remeron SolTab (mirtazapine)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved January 2001

Specific Treatments:


General Information

Remeron SolTab is an orally disintegrating tablet that has been approved for the treatment of depression. Unlike other antidepressant tablets, which must be swallowed whole, Remeron SolTab dissolves on the tongue within 30 seconds. This easy delivery method may enhance patient compliance as the tablet can be swallowed with or without water, chewed or allowed to disintegrate.

Along with its unique delivery system, Remeron SolTab has a novel pharmacological profile that increases the levels of both norepinephrine and serotonin in the brain to effectively fight depression. This is in contrast to many antidepressants, which only increase serotonin. According to the company, the product is suitable for depressed patients of all ages.

According to the National Mental Health Association, clinical depression is one of the most common mental illnesses, affecting more than 19 million Americans each year. Unfortunately, fewer than half of those suffering from depression get the treatment they need -- and others stop treatment too soon.

Organon is the United States human healthcare business of Akzo Nobel. Organon and Solvay Pharmaceuticals have contracted to co-promote Remeron SolTab.

Clinical Results

Remeron SolTab is an orally disintegrating tablet version of Remeron (mirtazapine) Tablets. 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. The mean mirtazapine dose for subjects who completed these four studies ranged from 21 to 32 mg per day. A fifth study of similar design utilized a higher dose (up to 50 mg) per day, which also showed effectiveness. (from Remeron Prescribing Information)

Side Effects

Adverse events associated with the use of mirtazapine may include (but are not limited to) the following:

  • Somnolence (sleepiness)
  • Dry mouth
  • Increased appetite
  • Weight gain
  • Dizziness

Mechanism of Action

The mechanism of action of Remeron (mirtazapine) Tablets, as with other antidepressants, is unknown. Mirtazapine has a tetracyclic chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics or monoamine oxidase inhibitors (MAOI). It belongs to the piperazino-azepine group of compounds.

According to preclinical studies, mirtazapine enhances central noradrenergic and serotonergic activity. These studies have shown that mirtazapine acts as an antagonist at central presynaptic a2 adrenergic inhibitory autoreceptors and heteroreceptors, which may contribute to the increase in central noradrenergic and serotonergic activity. (from Remeron Prescribing Information)

Additional Information

For additional information on Remeron SolTab, please visit Organon.

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