Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Endocrinology | Psychiatry/Psychology | Family Medicine
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved June 1996
Treatment Area: depression
Remeron has been approved for the treatment of depression.
The FDA clearance of Remeron is based on efficacy data from
clinical trials involving approximately 3,000 people. Results from
placebo and amitriptyline-controlled clinical trials supported the
conclusion that Remeron provides effective relief of
Side effects observed in clinical trials were mostly mild and
generally have not caused subjects to stop taking Remeron. The
commonly reported drug-related side effects in subjects taking
Remeron were somnolence, increased appetite, weight gain, and
Mechanism of Action
Remeron is the first agent in a new class of anti-depressants.
Remeron stimulates norepinephrine and serotonin release while also
blocking two serotonin receptors (5-HT2 and 5-HT3).