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The federal agency expanded its approval of a once-a-day medication to manage low libido in women to now encompass postmenopausal women up to the age of sixty-five.

Prior to the recent news, the drug, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was originally authorized by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

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

Currently, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of Addyi commended the FDA’s action to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Other women’s health experts voiced approval for the decision.

“I had few tools for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be crucial to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “understandable” given the available data.

Although supportive, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not substantial. Is it worthwhile taking a drug daily and not getting bang for your buck?”

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

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was initially researched as an medication for depression but was considered unsuccessful during early studies.

However, researchers noted improvements in measures of libido and arousal and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a major lobbying effort.

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

Official guidance advises allowing a two-hour gap after drinking before taking the drug to reduce the risk of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining Addyi and alcohol eventually prompted the maker to fund additional studies investigating the interaction. The research, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had concerns.

“This research aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An gynecologist suggested 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 syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still expand treatment options for low desire to a new population of women who may find help.

“I do think it will benefit this population better as long as they have no other medical problems,” said an specialist.

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

So treating HSDD means considering everything from partnership issues to shifts in hormone levels.

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, managing these symptoms is often a first step toward sexual wellness.

“If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as treatments to treat the symptoms 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 concerned 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 besides medication, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing sexual desire are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in later life,” said an OB-GYN. “This involves understanding 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 peak of orgasm.”