Is Sertraline (selective serotonin reuptake inhibitor) effective for treating premenstrual symptoms in premenopausal women?

From the Guidelines

Sertraline is a recommended treatment option for managing premenopausal symptoms, particularly for mood-related issues and hot flashes, as supported by the American Cancer Society/American Society of Clinical Oncology breast cancer survivorship care guideline 1.

Key Points to Consider

• The guideline recommends offering SNRIs, selective serotonin reuptake inhibitors (SSRIs), gabapentin, lifestyle modifications, and/or environmental modifications to help mitigate vasomotor symptoms of premature menopausal symptoms 1.
• Sertraline, an SSRI, can decrease the intensity and severity of vasomotor symptoms, although it is not approved by the US Food and Drug Administration for this indication 1.
• The typical starting dose of sertraline is 50mg daily, which can be increased to 100-200mg daily if needed after 1-2 weeks based on symptom response.
• Treatment duration varies, but often continues for 6-12 months with reassessment of symptoms before considering tapering.
• Side effects may include nausea, headache, insomnia, and sexual dysfunction, which often improve after 2-4 weeks of treatment 1.

Important Considerations

• There is concern that SSRIs, such as paroxetine, may reduce the conversion of tamoxifen to active metabolites, although a negative impact on breast cancer outcomes has not been conclusively demonstrated 1.
• Patients should not be screened for CYP2D6, as recommended by the ASCO and NCCN 1.
• Lifestyle interventions, including rhythmic breathing, vitamins, exercise, and avoiding spicy foods, caffeine, and alcohol, have had variable results, but may be helpful in reducing menopausal symptoms 1.
• Environmental modifications, such as cool rooms and dressing in layers, can also be helpful in decreasing the intensity and severity of menopausal symptoms 1.

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 Patients in Study 1 met DSM-III-R criteria for Late Luteal Phase Dysphoric Disorder (LLPDD), the clinical entity now referred to as Premenstrual Dysphoric Disorder (PMDD) in DSM-IV. Efficacy was assessed with the Daily Record of Severity of Problems (DRSP), a patient-rated instrument that mirrors the diagnostic criteria for PMDD as identified in the DSM-IV, and includes assessments for mood, physical symptoms, and other symptoms 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) in premenopausal women. The recommended dosing is either 50-150 mg/day administered daily throughout the menstrual cycle or 50-100 mg/day administered in the late luteal phase of the menstrual cycle. 2

From the Research

Sertraline for Premenopausal Symptoms

• There is no direct evidence in the provided studies regarding the use of sertraline for premenopausal symptoms 3, 4, 5, 6, 7.
• However, study 7 discusses the treatment of perimenopausal depression, which may be relevant to premenopausal symptoms, and suggests that antidepressants are a front-line treatment for perimenopausal depression.
• Sertraline is an antidepressant, but its specific use for premenopausal symptoms is not mentioned in the provided studies.
• Study 5 mentions that non-hormonal treatment options are available for menopausal symptoms, but does not specify sertraline as an option.
• Study 4 discusses hormonal treatment for perimenopause disorders, but does not mention sertraline.
• Studies 3 and 6 focus on cognitive behavioral therapy for menopausal symptoms, and do not mention sertraline.