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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to address low libido in women to cover women after menopause up to age 65.

Prior to the announcement, the medication, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

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

Additional OB-GYNs were supportive for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be crucial to address 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 approval was “quite reasonable” given the available data.

Although supportive, the expert was guarded in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the enhancement is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was originally developed as an medication for depression but was found to be lacking during early studies.

However, scientists noted improvements in aspects 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 cleared in 2015 to treat HSDD, following further studies and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

Official guidance recommends waiting at least two hours after drinking before taking Addyi to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the label advises not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund additional studies investigating the combination. The studies, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.

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

An gynecologist suggested that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

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

“I don’t know if that has to do with the intricacies of the drug. Reviewing 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 clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a different group of women who may benefit.

“I do think it will serve this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a quick fix. In fact, the experts consulted all agreed that the female libido is influenced by many factors.

So addressing HSDD means considering everything from relationship dynamics to hormonal changes.

Women after menopause navigate a wide variety of symptoms that can affect libido. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

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

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also occasionally used without formal approval to address reduced desire in females, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

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

Additional suggestions for boosting libido are:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” 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 aroused, and ultimately to have a climax of sexual pleasure.”