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On June 28, 2013, the FDA approved a 7.5-mg formulation of paroxetine mesylate (Brisdelle) for treatment of moderate to severe menopausal hot flashes. Recommended dosing is one 7.5-mg oral capsule daily at bedtime.
To assess efficacy and safety, researchers conducted two randomized, double-blind, placebo-controlled trials in a total of 1175 women who reported experiencing at least 7 to 8 moderate-to-severe hot flashes daily. Brisdelle reduced daily hot flash frequency more than placebo: The difference between the median changes from baseline was 1 to 2 hot flashes daily. The mechanism of action for alleviating hot flashes remains unknown.