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The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to address low libido in females to now encompass postmenopausal women up to the age of sixty-five.

Prior to the recent news, the drug, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a long and debated evaluation period.

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

Currently, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

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

Other women’s health experts voiced approval 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 approval for this patient population could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the existing research.

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

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

The drug was first created as an medication for depression but was found to be lacking during initial trials.

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

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

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

Official guidance advises waiting at least two hours after consuming alcohol before using Addyi to minimize the chance of fainting. If a person has several drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the maker to fund further research examining the combination. The studies, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had reservations.

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

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

“There have been adverse reactions like the fainting spells 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 things like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was limited at age 65.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a different group of women who may find help.

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

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

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

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

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also sometimes used without formal approval to address low libido in females, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable recommending flibanserin 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.

Additional suggestions for boosting sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in later life,” said an expert. “This involves knowing how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”