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The Food and Drug Administration (FDA) expanded its approval of a daily pill to address low libido in females to include women after menopause up to the age of sixty-five.

Before the recent news, the pill, flibanserin (Addyi), was only approved to treat low sexual desire in premenopausal females.

Flibanserin was initially cleared by the FDA in 2015, following a lengthy and contentious evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, Addyi 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 praised the FDA’s move to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health expressed support for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be significant to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the clinical evidence.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the enhancement is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Addyi, the ‘Women's Desire Pill’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

The drug was first created as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, scientists noted improvements in measures of sexual function 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 advocacy campaign.

The medication carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

Official guidance recommends waiting at least two hours after drinking before using Addyi to minimize the risk of fainting. 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 mixing the drug with drinking eventually led the maker to fund further research investigating the interaction. The research, which were limited in size, demonstrated no increased danger of fainting. But experts had reservations.

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

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

“Patients have experienced 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 susceptible to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at age 65.

“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 easier information sheet because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Despite these risks, flibanserin could still expand therapeutic choices for HSDD to a new population of females who may find help.

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

But it is not a magic bullet. In fact, the specialists consulted universally acknowledged that the female libido is influenced by many factors.

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

Women after menopause navigate a broad range of symptoms that can impact sexual desire. Symptoms of menopause encompass:

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

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

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more women to feel less concerned about it and to consider it as a viable choice.

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

But besides medication, experts say that personal habits should also be considered. Discussions about libido 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 psychosocial issues going on,” she said.

Other suggestions for increasing sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “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 excited, and ultimately to have a climax of sexual pleasure.”