A selective serotonin reuptake inhibitor (SSRI) for treating premenstrual dysphoric disorder (PMDD), the second SSRI and second drug approved for this indication.

* Recommended Dosage: 50 mg/day throughout the menstrual cycle or during the luteal phase. If necessary, dose may be increased at 50-mg increments per cycle, up to 150 mg/day when taken throughout the cycle or 100 mg/day when taken during the luteal phase.

* Special Considerations: Effectiveness beyond 3 months has not been evaluated.

* Comment: Approval was based on two studies of Zoloft vs. placebo over three menstrual cycles. In a study of 251 patients, those who took Zoloft 50 mg/day during the first cycle, then 50-150 mg/day during later cycles, had significantly greater improvements, compared with placebo. In an intermittent dosing study of 281 patients, those on Zoloft 50 mg/day in the late luteal phase during the first cycle, and 50-100 mg/day in later cycles, also had significantly greater improvements.

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