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The Food and Drug Administration (FDA) widened the indication of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to the age of sixty-five.

Before the recent news, the medication, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the agency expressed reservations about its safety profile, efficacy, and an concerning balance of risks and benefits.

Now, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin commended the FDA’s decision to broaden the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Additional OB-GYNs were supportive for the decision.

“I had few tools for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be significant to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

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

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

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

The drug was initially researched as an antidepressant but was deemed ineffective during initial trials.

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

After two rejections, flibanserin was approved in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for serious side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

The label advises allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person has 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 led the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were limited in size, showed no additional risk of syncope. But experts had concerns.

“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 speculated that this may have been part of the reason why Addyi was not originally approved for older females.

“There have been side effects like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to things like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was capped at 65 years of age.

“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.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden treatment options 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 simple solution. In fact, the experts interviewed all agreed that the female libido 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 symptoms that can affect sexual desire. Symptoms of menopause encompass:

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

According to one expert, managing these symptoms is often a first step toward sexual wellness.

“If somebody came to me with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as options to treat the symptoms of menopause, particularly dryness.

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

Testosterone is also sometimes used without formal approval to treat reduced desire in women, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing flibanserin 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 libido include:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “This involves knowing 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 orgasm.”