The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration today approved Brisdelle (paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.
There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.
Hot flashes associated with menopause occur in up to 75 percent of women and can persist for up to five years, or even longer in some women. Hot flashes are not life-threatening, but the symptoms can be very bothersome, causing discomfort, embarrassment and disruption of sleep.
For more information please visit: Brisdelle
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