From the FDA Drug Label
The effectiveness of sertraline for the treatment of PMDD was established in two double-blind, parallel group, placebo-controlled flexible dose trials (Studies 1 and 2) conducted over 3 menstrual cycles In Study 1, involving n=251 randomized patients; sertraline treatment was initiated at 50 mg/day and administered daily throughout the menstrual cycle Sertraline administered daily throughout the menstrual cycle was significantly more effective than placebo on change from baseline to endpoint on the DRSP total score, the HAMD-17 total score, and the CGI-S score, as well as the CGI-I score at endpoint In Study 2, involving n=281 randomized patients, sertraline treatment was initiated at 50 mg/day in the late luteal phase (last 2 weeks) of each menstrual cycle and then discontinued at the onset of menses Sertraline administered in the late luteal phase of the menstrual cycle was significantly more effective than placebo on change from baseline to endpoint on the DRSP total score and the CGI-S score, as well as the CGI-I score at endpoint
Sertraline is effective for the treatment of Premenstrual Dysphoric Disorder (PMDD) 1.
- The recommended dosage is 50 mg/day, administered daily throughout the menstrual cycle or in the late luteal phase of the menstrual cycle.
- Key benefits of sertraline for PMDD include significant improvement in symptoms such as mood, physical symptoms, and other symptoms, as measured by the Daily Record of Severity of Problems (DRSP) and the Clinical Global Impression Severity of Illness (CGI-S) score.
From the Research
Sertraline (Zoloft, 50-150mg daily) is the most effective SSRI for treating Premenstrual Dysphoric Disorder (PMDD), as supported by the most recent and highest quality study 2.
Overview of PMDD Treatment
PMDD is a severe form of premenstrual syndrome that can significantly impair daily life. The treatment of PMDD typically involves the use of selective serotonin reuptake inhibitors (SSRIs), which have been shown to improve symptoms and quality of life in women with PMDD.
Effective SSRIs for PMDD
The following SSRIs have been found to be effective in treating PMDD:
- Sertraline (Zoloft, 50-150mg daily) 2
- Fluoxetine (Prozac, 10-20mg daily) 2
- Escitalopram (Lexapro, 10-20mg daily) 2
- Paroxetine (Paxil, 12.5-25mg daily) 2
Dosage and Administration
SSRIs can be taken either daily or intermittently during the luteal phase (14 days before menses). Intermittent dosing has been found to be effective and may be recommended before continuous daily dosing 3.
Side Effects and Benefits
Common side effects of SSRIs include nausea, headache, insomnia, and decreased libido, but these often improve after 1-2 weeks. The benefits of SSRIs in treating PMDD include improved symptoms, quality of life, and functional impairment.
Recommendation
Based on the most recent and highest quality study, sertraline (Zoloft, 50-150mg daily) is the recommended SSRI for treating PMDD 2. If one SSRI does not work or causes intolerable side effects, trying another is reasonable as individual responses vary.