Is Flibanserin safe to use?

Is Flibanserin safe for women with HSDD?

This is a question we receive quite often from women who have heard of the drug Flibanserin – sold under the brand name Addyi.  A recent study has shown that the general consensus from medical researchers is “yes”.

Flibanserin “Generally Safe and Well-Tolerated”.

 

Flibanserin, a drug used to treat hypoactive sexual desire disorder (HSDD), has been deemed safe for both premenopausal women and women who have gone through natural menopause, according to new research.

Flibanserin, a drug used to treat low sexual desire, is “generally safe and well-tolerated” for both premenopausal and naturally postmenopausal women, according to trial results published in the Journal of Sexual Medicine.

More specifically, the drug is designed to treat hypoactive sexual desire disorder (HSDD). Women with HSDD lose interest in sex for reasons that can’t be readily explained. This lack of libido is persistent. The women do not desire sex with a partner, nor do they have sexual fantasies.

One of the diagnostic criteria of HSDD is distress. Women with HSDD feel distress about their situation. Indeed, HSDD can take its toll on relationships, and partners may wonder why the sexual interest isn’t there, especially if they have enjoyed a healthy sexual relationship in the past. Women may miss the intimacy they once shared with their partner.

Flibanserin, marketed under the brand name Addyi, works by rebalancing two neurotransmitters in the brain: dopamine and norepinephrine. In 2015, the drug was approved by the U.S. Food and Drug Administration (FDA) in for use in premenopausal women with acquired, generalized HSDD. Acquired means that their HSDD started after a period of normal sexual function. Generalized means that their lack of sex drive occurs almost all the time, not just in certain situations.

However, the FDA has not approved the use of flibanserin by postmenopausal women with HSDD. This study included data on both premenopausal women and naturally postmenopausal women. (The women went through menopause through the typical course of aging, not through medical treatments like surgery.)

The trial included 595 women. Three hundred forty-six women were premenopausal (average age 38), and 259 had finished natural menopause (average age 57). All the women had been in monogamous, heterosexual relationships for at least a year.

All participants took 100 mg of flibanserin every night when they went to bed. During periodic follow-up visits, they completed questionnaires that assessed their sexual distress and sexual function. They were also checked for any adverse events (side effects).

The study was originally designed to last for 28 weeks. However, the study sponsor, the German company Boehringer Ingelheim, stopped their development of flibanserin, so the study ended early. On average, the women participated for about ten weeks, but some went as long as 24 weeks.

In general, the women’s levels of sexual distress decreased while their sexual function improved. About half of the patients said they had received a “meaningful benefit” from flibanserin.

Almost 60% of the women experienced adverse events. Of these, 94% said those effects were mild or moderate. The most common side effects were dizziness, drowsiness, insomnia, and nausea. Menopausal status did not appear to affect the safety of flibanserin. In other words, the drug was found to be equally safe for the women whether they had gone through menopause or not.

One in sixteen women left the trial early because of adverse events, the researchers reported.

The study did have some limitations. Because the sponsor ended the study early, the researchers did not have data for the intended 28 weeks. There was no placebo group in the trial, so the researchers could not compare the participants’ outcomes with those of women who did not take flibanserin.

Also, the women in this study were heterosexual and in monogamous relationships, so the results might not necessarily apply to lesbian women, bisexual women, or those in open relationships.

In addition, the postmenopausal women in the study went through natural menopause. It was not known how flibanserin would affect women who had undergone medical menopause (such as from cancer treatments like surgery, radiation, and chemotherapy.)

Resources

The Journal of Sexual Medicine

Simon, James A., MD, et al.

“Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study”

(Full-text. March 2018)

https://www.jsm.jsexmed.org/article/S1743-6095(18)30006-7/fulltext

SexHealthMatters.org

“Understanding HSDD”

http://www.sexhealthmatters.org/hsdd/understanding-hsdd

“What Should I Know About Addyi?”

(August 26, 2015)

http://www.sexhealthmatters.org/sex-health-blog/what-should-i-know-about-addyi

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