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

Before the recent news, the medication, flibanserin (Addyi), was solely authorized to treat low sexual desire 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 separate occasions, in 2010 and 2013. In each instance, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

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

The founder and CEO of the maker of flibanserin applauded the FDA’s move to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

Additional OB-GYNs expressed support for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population 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 clinical professor told reporters that the approval was “logical” given the available data.

Although supportive, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was originally developed as an antidepressant but was deemed ineffective during initial trials.

However, researchers noted positive changes in aspects of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

The medication carries a serious safety warning for severe 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 drinking before taking the drug to minimize the risk of fainting. If a person has several drinks on a single occasion, the label recommends skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no additional risk of syncope. But experts had concerns.

“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 OB-GYN suggested that this may have been part of the reason why Addyi was not initially cleared for older females.

“There have been side effects like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. 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 limited at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. Reviewing 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 Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for HSDD to a new population of females who may benefit.

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

But it is not a quick fix. In fact, the experts consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

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

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate the symptoms 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 viable choice.

Testosterone is also sometimes prescribed off-label to treat low libido in females, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for boosting sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended foreplay
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in older age,” said an OB-GYN. “This involves understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”