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The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to manage low libido in females to now encompass postmenopausal women up to age 65.

Prior to this week's decision, the pill, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in women of reproductive age.

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

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Today, Addyi is the only FDA-approved oral medication 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 commended the FDA’s move to broaden the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other specialists in female health were supportive for the decision.

“I had few tools for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

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

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

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

Addyi, which is often called “the women's version of Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was originally developed as an medication for depression but was deemed ineffective during initial trials.

However, scientists noted improvements in aspects of libido and arousal and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant advocacy campaign.

Addyi carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before taking Addyi to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the interaction. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had concerns.

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

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

“Patients have experienced adverse reactions like the syncopal episodes and dizziness 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 sensitive to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the instructions and restrictions, 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 Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for low desire to a different group 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 specialist.

But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the women's sexual desire is influenced by many factors.

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

Women after menopause navigate a wide variety of changes that can affect sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these symptoms is often a initial approach 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 topical estrogen therapy and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less concerned about it and to view it as a viable choice.

Testosterone is also occasionally used without formal approval to treat reduced desire in females, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be factored in. Discussions about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem recommending flibanserin after having a conversation 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 boosting libido include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexuality and this life stage in older age,” said an OB-GYN. “That means knowing 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 orgasm.”