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The federal agency broadened the authorized use of a daily pill to treat low libido in women to now encompass women after menopause up to age 65.

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

The drug was originally authorized by the FDA in 2015, following a protracted and controversial evaluation period.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA expressed reservations about its safety profile, effectiveness, 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 on-demand injection, in two thousand nineteen.

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

Other women’s health experts were supportive for the decision.

“I had few tools for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this patient population could be crucial to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not substantial. Is it worthwhile 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 few similarities with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

However, scientists noted positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a considerable advocacy campaign.

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

Official guidance recommends allowing a two-hour gap after drinking before using the drug to reduce the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

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

“This research aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“Patients have experienced side effects like the syncopal episodes and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor echoed confusion 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 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 easier information sheet because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

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

“I believe it will serve this population better as long as they have no other medical problems,” 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 addressing low desire means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a wide variety of symptoms that can affect sexual desire. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• 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 libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She hopes that the regulatory decision to lift of its “serious” 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 sometimes used without formal approval to treat low libido in females, although it is not indicated for it.

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

“I would have no problem recommending 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.

Additional suggestions for increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexual health and this life stage in later life,” said an expert. “This involves knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”