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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to age 65.

Before the announcement, the pill, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and 2013. In each instance, the agency expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the maker of Addyi commended the FDA’s action to broaden the drug’s indication, calling it a “landmark event” in understanding and prioritizing female sexual health.

Additional OB-GYNs were supportive for the regulatory move.

“There was nothing for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

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

Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?”

Understanding Flibanserin, 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.

The drug was initially researched as an antidepressant but was found to be lacking during initial trials.

However, researchers noted positive changes in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label advises waiting at least two hours after drinking before taking Addyi to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Claims about the interactions of combining the drug with drinking eventually prompted the maker to fund further research investigating the interaction. The studies, which were limited in size, demonstrated no increased danger of fainting. But experts had reservations.

“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 OB-GYN speculated that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

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

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Low Libido After Menopause

Notwithstanding the warnings, Addyi could still expand treatment options for low desire to a different group of women who may find help.

“I believe it will benefit this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the female libido is complex and multifaceted.

So treating HSDD means considering everything from partnership issues to hormonal changes.

Postmenopausal females navigate a wide variety of changes that can impact libido. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

According to one expert, managing these issues is often a initial approach 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 hormone replacement therapy (HRT) as treatments to alleviate the effects of menopause, particularly vaginal dryness.

She expressed hope 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.

Testosterone is also occasionally prescribed off-label to treat low libido in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Conversations about sexual desire almost always start with relationships and intimacy.

“I would have no problem 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.

Other recommendations for increasing libido are:

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

“It requires an entire whole body approach to sexuality and this life stage in older age,” said an expert. “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 peak of orgasm.”