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The Food and Drug Administration (FDA) widened the indication of a oral treatment to address low libido in females to include women after menopause up to the age of sixty-five.

Prior to the announcement, the pill, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of Addyi praised the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs expressed support for the decision.

“Previously, options were limited for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance 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 news outlets that the approval was “logical” given the available data.

Although supportive, the expert was guarded in her assessment: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not dramatic. Is it worthwhile taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Women's Desire Pill’?

Addyi, which is often called “female Viagra,” has little in common with the drug from which it draws its nickname.

This medication was initially researched as an antidepressant but was considered unsuccessful during initial trials.

However, scientists noted improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

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

The medication carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

The label recommends allowing a two-hour gap after consuming alcohol before using Addyi to reduce the risk of syncope. If a person has several drinks on a given day, the label advises skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had reservations.

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

An gynecologist speculated that this may have been part of the reason why the drug was not originally approved for older females.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.

Another doctor echoed confusion about why the broader approval was limited at age 65.

“I don’t know if that has to do with the complexity of the medication. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, 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, Addyi could still broaden treatment options for low desire to a different group of women who may benefit.

“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 specialists interviewed all agreed that the women's sexual desire is influenced by many factors.

So treating low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a broad range of changes that can impact sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Androgen therapy is also sometimes used without formal approval to treat low libido in females, although it is not officially approved 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 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 recommendations for increasing libido are:

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

“You have to take an comprehensive, holistic strategy to sexuality and menopause in older age,” said an OB-GYN. “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 excited, and ultimately to have a peak of sexual pleasure.”