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The federal agency broadened the authorized use of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to 65 years old.

Prior to the announcement, the pill, Addyi (flibanserin), was exclusively cleared to treat low sexual desire in women of reproductive age.

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

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In each instance, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s action to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be very important to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the approval 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 enhancement is not dramatic. Does it justify taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

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

This medication was initially researched as an antidepressant but was deemed ineffective during initial trials.

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

Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

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

The label advises allowing a two-hour gap after consuming alcohol before taking the drug to reduce the chance of fainting. If a person consumes several drinks on a single occasion, the label advises skipping the dose entirely.

Assertions about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund further research investigating the interaction. The studies, which were small in scale, showed no increased danger of syncope. But experts had reservations.

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

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

“There have been side effects like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

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

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

Addressing Low Libido After Menopause

Despite these risks, flibanserin could still broaden 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 medical problems,” said an specialist.

But it is not a quick fix. In fact, the specialists interviewed all agreed that the women's sexual desire is complex and multifaceted.

So addressing low desire means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females experience a broad range of changes that can affect libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

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

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the symptoms of menopause, particularly vaginal 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 concerned about it and to view it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to address reduced desire in females, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be considered. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing libido are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “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 aroused, and ultimately to have a peak of sexual pleasure.”