Brisdelle Approved to Treat Menopause Symptoms

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In June 2013, the first non-hormonal treatment for hot flashes associated with menopause was approved by the U.S. Food and Drug Administration (FDA). Paroxetine (Brisdelle), which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is approved to treat moderate to severe hot flashes. It is the first menopause treatment approved by the FDA that does not contain estrogen or estrogen plus a progestin.

Studies show that paroxetine reduces the frequency and severity of hot flashes and night sweats compared to placebo in women who experienced a minimum of 7 or 8 symptoms per day/50 - 60 per week. It is available in capsule form and is taken once daily, at bedtime.

Brisdelle contains 7.5 mg of paroxetine. Medications used to treat conditions such as major depressive disorder, obsessive-compulsive disorder (OCD), panic disorders, and generalized anxiety disorder (GAD) contain higher doses of this drug. All medicines that contain paroxetine, including Brisdelle, have a Boxed Warning on the label about the potential for causing an increased risk for suicidal thoughts and actions in children and young adults.

Common side effects include headache, fatigue, nausea and vomiting. Brisdelle may reduce the effectiveness of tamoxifen, when the medications are used together. (Tamoxifen is an anti-estrogen used to treat breast cancer or reduce breast cancer risk.)

Brisdelle may increase the risk for abnormal bleeding/bruising and for serotonin syndrome, which causes confusion, rapid heart rate, high blood pressure, and other symptoms. Women who take Brisdelle also may have a higher risk for bone fractures and problems with vision. This drug should not be used in women who are or may be pregnant, women who are breastfeeding, those who are taking or have recently taken a monoamine oxidase inhibitor (MAOI), or those who take antipsychotic medications like thioridazine or pimozide.

If you think Brisdelle might be right for you, talk to your health care provider. Be sure to tell him/her about all prescription and over-the-counter (OTC) medications you are taking, as well as any herbal or dietary supplements. Also tell your doctor if you have a history of liver or kidney problems, low blood sodium levels, glaucoma, seizures, convulsions, bleeding disorders, or bipolar disorder.

According to our sister publication REMEDY's Healthy Living Fall 2014, a clinical trial of more than three hundred women approaching or just past menopause suggests that the antidepressant venlafaxine (Effexor) may be as effective as estrogen therapy for hot flashes and night sweats.

At the start of the eight-week study, women suffered an average of eight hot flashes per day. By the end of the study, women in the antidepressant group reported a 48 percent reduction in hot flashes - similar to the 53 percent reduction seen in the estrogen therapy group.

Publication Review By: the Editorial Staff at

Published: 01 Jul 2013

Last Modified: 14 Aug 2014