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U.S. regulators broadened the authorized use of a oral treatment to address hypoactive sexual desire disorder (HSDD) in women to cover women after menopause up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was only approved to address low sexual desire in premenopausal females.

Flibanserin was first approved by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s action to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs were supportive for the regulatory move.

“There was nothing for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be crucial to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

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

While in favor, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not substantial. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

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

The drug was first created as an antidepressant but was considered unsuccessful during early studies.

However, researchers observed improvements in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label recommends waiting at least two hours after drinking before using the drug to reduce the chance of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends skipping the dose entirely.

Assertions about the effects of combining the drug with drinking eventually led the maker to fund further research examining the interaction. The research, which were small in scale, showed no increased danger of fainting. But experts had concerns.

“These studies aren't very convincing to me. They are a good start, but they’re not very big and certainly are short-term,” a public health expert stated.

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

“There have been side effects like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the drug. 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 Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a different group of females who may benefit.

“I believe it will serve this demographic better as long as they have no other health issues,” said an specialist.

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

So addressing low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause navigate a wide variety of symptoms that can affect sexual desire. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, treating these issues is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to alleviate 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 concerned about it and to view it as a viable choice.

Testosterone is also occasionally used without formal approval to treat low libido in women, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem prescribing flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing sexual desire are:

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

“You have to take an entire whole body approach to sexual health and this life stage in older age,” said an OB-GYN. “That means understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”