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The federal agency expanded its approval of a daily pill to manage low libido in females to include postmenopausal women up to the age of sixty-five.

Before the announcement, the pill, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

This medication was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

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

The founder and CEO of the maker of Addyi praised the FDA’s decision to expand the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Other specialists in female health were supportive for the decision.

“I had few tools for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “logical” given the available data.

While in favor, the expert was measured in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the improvement is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

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

Addyi, which is often called “female Viagra,” has little in common with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was deemed ineffective during early studies.

However, scientists noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

The medication carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking the drug to reduce the risk of syncope. If a person consumes several drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies investigating the combination. The research, which were small in scale, demonstrated no additional risk of syncope. But experts had concerns.

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

An OB-GYN suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

“Patients have experienced 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 effects 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 drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Treating Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for low desire to a different group of females who may benefit.

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

But it is not a simple solution. In fact, the experts interviewed all agreed that the women's sexual desire is complex and multifaceted.

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

Women after menopause experience a wide variety of symptoms that can impact sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, treating these symptoms is often a first step toward improved intimacy.

“If somebody came to me 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 options to alleviate the effects of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

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

But besides medication, experts say that personal habits should also be considered. Conversations about sexual desire almost always start with relationships and intimacy.

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

Additional suggestions for boosting sexual desire are:

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

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an OB-GYN. “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 sexual pleasure.”