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U.S. regulators expanded its approval of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to the age of sixty-five.

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

Flibanserin was first approved by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the FDA expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of Addyi applauded the FDA’s decision to broaden the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Additional OB-GYNs expressed support for the regulatory move.

“There was nothing for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “logical” given the available data.

While in favor, the expert was measured in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the enhancement is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

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

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

The drug was originally developed as an antidepressant but was found to be lacking during initial trials.

However, scientists noted positive changes in measures of sexual function and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant advocacy campaign.

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

The label advises allowing a two-hour gap after drinking before taking the drug to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually prompted the maker to fund additional studies examining the combination. The studies, which were limited in size, demonstrated no increased danger of syncope. But experts had concerns.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN speculated that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed uncertainty about why the broader approval 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.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a new population of women who may find help.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a quick fix. In fact, the specialists interviewed all agreed that the female libido is influenced by many factors.

So addressing HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a broad range of changes that can impact sexual desire. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing these issues is often a initial approach toward improved intimacy.

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

Testosterone is also sometimes prescribed off-label 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 sexual desire almost always start with relationships and intimacy.

“I am comfortable prescribing Addyi 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.

Other recommendations for increasing libido include:

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

“You have to take an entire whole body approach to sexual health and this life stage 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 sexual pleasure.”