Adverse effects limit the usefulness of fluvoxamine for the treatment of alcoholism.

Open-label and placebo-controlled trials of fluvoxamine, a selective, serotonergic antidepressant, were conducted as an adjunct to relapse prevention psychotherapy in alcoholics. In the open trial, 16 inpatient alcoholics began a 12-week treatment program, with 10 patients dropping out during the first 4 weeks of treatment. In the controlled trial, 8 of 10 patients on fluvoxamine dropped out during the first 4 weeks of treatment, compared with only 1 of 9 patients on placebo. Baseline patient characteristics did not appear to explain the differential attrition in the controlled trial, although the placebo-treated patients were more alcohol dependent. In both trials, patients on fluvoxamine complained of a variety of adverse effects, which they often identified as the basis for early termination of treatment. These adverse effects appear to limit the usefulness of the medication for the treatment of alcoholism.