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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to treat low libido in females to cover women after menopause up to the age of sixty-five.

Prior to the recent news, the pill, flibanserin (Addyi), was only approved to address 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 evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA cited issues about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of flibanserin applauded the FDA’s move to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

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

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be crucial to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the improvement is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was first created as an medication for depression but was considered unsuccessful during initial trials.

Nevertheless, scientists observed positive changes in measures of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

Addyi carries a serious safety warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label recommends allowing a two-hour gap after drinking before taking the drug to minimize the chance of fainting. If a person consumes several drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund additional studies investigating the interaction. The studies, which were small in scale, showed no increased danger of syncope. But experts had concerns.

“These studies don’t seem very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN suggested 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 dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor expressed uncertainty about why the expanded indication was limited at 65 years of age.

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

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand treatment options for low desire to a new population of females who may benefit.

“I do think it will benefit 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 complex and multifaceted.

So treating low desire means considering everything from partnership issues to shifts in hormone levels.

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

As noted by one expert, treating these symptoms is often a first step toward improved intimacy.

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more females 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 women, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending Addyi after discussing it 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:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in older age,” 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.”