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The Food and Drug Administration (FDA) broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to the age of sixty-five.

Before the recent news, the drug, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

This medication was initially cleared by the FDA in 2015, following a protracted and controversial evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA cited issues about safety, efficacy, and an unfavorable risk–benefit profile.

Today, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s action to expand the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other specialists in female health 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 OB-GYN. “Securing the FDA approval for this patient population could be crucial to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “quite reasonable” given the available data.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the magnitude of the benefit is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

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

The drug was initially researched as an antidepressant but was deemed ineffective during initial trials.

Nevertheless, researchers noted improvements in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

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

The medication carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

Official guidance advises allowing a two-hour gap after drinking before using the drug to reduce the chance of fainting. If a person consumes several drinks on a given day, the label advises not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had concerns.

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

An OB-GYN suggested that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

“There have been adverse reactions like the fainting spells 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 effects 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 intricacies of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

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

“I believe 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 women's sexual desire is influenced by many factors.

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

Postmenopausal females experience a broad range of symptoms that can impact sexual desire. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, treating these symptoms is often a initial approach toward sexual wellness.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice.

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

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing flibanserin after discussing it with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for boosting libido are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• using sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” 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.”