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The federal agency broadened the authorized use of a daily pill to manage low libido in women to now encompass postmenopausal women up to the age of sixty-five.

Before the recent news, the drug, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA approved bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of Addyi praised the FDA’s move to broaden the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Other women’s health experts were supportive for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be significant to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the available data.

Although supportive, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not overwhelming. Does it justify taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

This medication was first created as an antidepressant but was considered unsuccessful during initial trials.

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

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

Addyi carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

Official guidance recommends waiting at least two hours after drinking before using the drug to reduce the risk of fainting. If a person consumes several drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the maker to fund further research investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of syncope. But experts had concerns.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN speculated that this may have been part of the reason why the drug was not initially cleared for postmenopausal women.

“There have been side effects like the fainting spells and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was limited at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand treatment options for low desire to a new population of females who may benefit.

“I believe it will benefit this demographic better as long as they have no other health issues,” said an specialist.

But it is not a magic bullet. In fact, the experts consulted all agreed that the female libido is complex and multifaceted.

So addressing HSDD means considering everything from partnership issues to hormonal changes.

Postmenopausal females navigate a wide variety of changes that can affect sexual desire. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

According to one expert, treating these issues is often a first step toward improved intimacy.

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to alleviate the effects of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a viable choice.

Testosterone is also sometimes prescribed off-label to treat reduced desire in females, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Discussions about sexual desire almost always start with relationships and intimacy.

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for boosting libido include:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter lubricants
• practicing extended foreplay
• using vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “That means knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”