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The Food and Drug Administration (FDA) widened the indication of a oral treatment to treat low libido in women to include women after menopause up to 65 years old.

Prior to the recent news, the drug, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was first approved by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

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

The chief executive of the maker of Addyi praised the FDA’s move to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Other specialists in female health were supportive for the decision.

“Previously, options were limited for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be significant to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the approval was “quite reasonable” given the clinical evidence.

While in favor, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the improvement is not overwhelming. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

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

This medication was initially researched as an antidepressant but was found to be lacking during initial trials.

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

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

Addyi carries a serious safety warning for serious side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to reduce the chance of fainting. If a person has several drinks on a single occasion, the label recommends not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually prompted the maker to fund additional studies investigating the combination. The research, which were small in scale, demonstrated no additional risk of fainting. But experts had concerns.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

An gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“There have been adverse reactions 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 susceptible to things like that,” she said.

Another doctor echoed confusion about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a new population of women who may find help.

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

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

So treating HSDD means engaging with everything from relationship dynamics to hormonal changes.

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

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, managing these symptoms is often a first step toward sexual wellness.

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

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

Androgen therapy is also occasionally prescribed off-label to address low libido in women, although it is not officially approved for it.

But besides medication, experts say that personal habits should also be considered. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable recommending 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 recommendations for increasing sexual desire include:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” said an expert. “That means understanding how your body works, your physiology, 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 sexual pleasure.”