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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to manage low libido in females to now encompass women after menopause up to the age of sixty-five.

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

This medication was initially cleared by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The founder and CEO of the maker of flibanserin commended the FDA’s decision to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional 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 menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

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

Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the degree of the enhancement is not substantial. Is it worthwhile taking a drug daily 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 medication from which it draws its nickname.

The drug was originally developed as an medication for depression but was deemed ineffective during early studies.

Nevertheless, scientists observed 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 approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

The label advises waiting at least two hours after consuming alcohol before using Addyi to reduce the risk of syncope. If a person consumes several drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies investigating the combination. The studies, which were limited in size, demonstrated no additional risk of syncope. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very big 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 adverse reactions like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to effects like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at age 65.

“I don’t know if that has to do with the intricacies of the medication. If you take 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 easier information sheet because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a new population of women who may benefit.

“I do think 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 interviewed universally acknowledged that the female libido is influenced by many factors.

So addressing low desire means considering everything from relationship dynamics to shifts in hormone levels.

Women after menopause experience a broad range of symptoms that can affect libido. Symptoms of menopause encompass:

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

As noted by one expert, managing these symptoms is often a initial approach toward improved intimacy.

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to treat the symptoms of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a treatment option.

Androgen therapy is also occasionally prescribed off-label to treat reduced desire in women, although it is not officially approved for it.

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

“I would have no problem recommending Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for boosting sexual desire include:

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

“You have to take an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “This involves knowing how your body works, your anatomy, 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.”