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

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

Flibanserin was originally authorized by the FDA in 2015, 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 concerning balance of risks and benefits.

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

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other specialists in female health expressed support for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this patient population could be crucial to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

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

Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the improvement is not substantial. 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 few similarities with the medication from which it gets its informal name.

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

Nevertheless, scientists noted improvements in aspects of sexual function and redirected efforts to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort.

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after consuming alcohol before using the drug to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund additional studies examining the combination. The studies, which were limited in size, showed no additional risk of syncope. But experts had reservations.

“This research aren't very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An gynecologist speculated 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 lightheadedness especially in persons who have had an drink 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 65 years of age.

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still broaden treatment options for HSDD to a new population of females who may find help.

“I do think it will serve 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 consulted universally acknowledged that the women's sexual desire is complex and multifaceted.

So treating low desire means considering everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a broad range of symptoms that can affect libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward sexual wellness.

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

The expert recommended both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly dryness.

She hopes 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 consider it as a treatment option.

Testosterone is also occasionally used without formal approval to treat low libido in females, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be considered. Conversations about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable recommending Addyi 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 increasing sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexuality and this life stage in older age,” said an OB-GYN. “That means understanding 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.”