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The Food and Drug Administration (FDA) expanded its approval of a daily pill to manage low libido in women to include women after menopause up to age 65.

Prior to the announcement, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The chief executive of the maker of flibanserin applauded the FDA’s move to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional specialists in female health voiced approval for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be significant to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the available data.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, the ‘Women's Desire Pill’?

Addyi, which is often called “female Viagra,” has little in common with the medication from which it gets its informal name.

This medication was originally developed as an antidepressant but was found to be lacking during initial trials.

However, researchers observed improvements in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, flibanserin was approved in 2015 to treat HSDD, following additional research and a major lobbying effort.

The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises waiting at least two hours after consuming alcohol before taking the drug to reduce the risk of syncope. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually led the maker to fund further research examining the interaction. The studies, which were limited in size, showed no increased danger of fainting. But experts had reservations.

“This research aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An gynecologist speculated that this may have been part of the cause why Addyi was not originally approved for older females.

“There have been side effects like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

Another doctor expressed confusion about why the broader approval was capped at age 65.

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Despite these risks, flibanserin could still broaden treatment options for HSDD to a different group of females who may find help.

“I do think it will serve this population better as long as they have no other medical problems,” said an OB-GYN.

But it is not a simple solution. In fact, the experts consulted universally acknowledged that the female libido is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to hormonal changes.

Postmenopausal females navigate a wide variety of changes that can impact sexual desire. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also occasionally prescribed off-label to treat low libido in women, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about libido almost always start with partnership dynamics and closeness.

“I would have no problem recommending Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for increasing libido include:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an expert. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”