Published August 20, 2013 WOMEN'S HEALTH FDA Approves Nonhormonal Treatment for Hot Flashes By Staff US Pharm. 2013;38(8):6. Bethesda, MD—The FDA has approved Brisdelle (paroxetine) to treat moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause. Hot flashes are very common and occur in up to 75% of menopausal women. Brisdelle, which contains the selective serotonin reuptake inhibitor (SSRI) paroxetine, is currently the only nonhormonal treatment for hot flashes approved by the FDA. There are a variety of other FDA-approved drugs for this condition, but all include estrogen. Brisdelle contains 7.5 mg of paroxetine, while other medications, such as Paxil and Pexeva, use higher doses of paroxetine and are approved for treating conditions such as depression, obsessive-compulsive disorder, and anxiety. As with all SSRIs, a boxed warning about suicidality is included in the Brisdelle label. To comment on this article, contact rdavidson@uspharmacist.com.