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(423) A Case Series of Successful Off-label Use of Flibanserin

P. Trowbridge, M. Padhye, R. Rubin

Journal of Sexual Medicine, 2023

Abstract

Flibanserin was the first FDA approved drug for hypoactive sexual desire disorder (HSDD) in premenopausal women, but was initially studied as an antidepressant without concern for age or gender. Flibanserin acts as partial agonist at the serotonin receptor 1A and antagonist at serotonin 2A receptor. The mechanism of action is thought to be due to an increase in dopamine and norepinephrine. Post hoc analysis during the pivotal trials showed improvement not just in desire, but in all domains of the Female Sexual Function Index (FSFI) including orgasm, arousal, lubrication and satisfaction. Off label use of flibanserin therefore is of interest to sexual medicine providers.

Described here, are four off label uses for flibanserin with successful outcomes in patient’s symptoms and quality of life, including post-orgasmic illness syndrome (POIS), low libido in a eugonadal male, a postmenopausal female with HSDD, and a patient with post-finasteride syndrome (PFS).

The first case is of a 40-year-old male patient who presented with a 10 year history of acquired POIS, with significantly debilitating symptoms lasting 1 week after orgasm. After trying a number of different multimodal treatment approaches he finally was on a regimen of Bupropion, Lexapro, Silodosin, Ritalin and Tramadol with a reduction in the duration of his symptoms from 1 week to 4 days, without a change in symptom intensity. Patient was then trialed on 200mg gabapentin nightly and 100mg flibanserin nightly, with…

How strong is the evidence?

Evidence Hub reads this as a case series, done in people. Its evidence level is 5 of 5 (Very low · case / narrative / animal / in vitro / in silico). Case reports, narrative reviews, and animal, cell or computer-model studies give the weakest evidence for human health.

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