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 depression.
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 dizziness.
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).