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The Food and Drug Administration (FDA) expanded its approval of a oral treatment to manage hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to the age of sixty-five.

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

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

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

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

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Additional OB-GYNs voiced approval for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to help women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “logical” given the existing research.

Although supportive, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the placebo, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

Addyi, which is often called “female Viagra,” has significant differences with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was deemed ineffective during initial trials.

Nevertheless, researchers observed improvements in measures of libido and arousal and shifted focus to the drug’s potential as a treatment for low libido.

Following initial denials, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant lobbying effort.

Addyi carries a serious safety warning for serious side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises waiting at least two hours after consuming alcohol before taking Addyi to minimize the risk of fainting. If a person has 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 maker to fund further research examining the combination. The studies, which were limited in size, showed no additional risk of fainting. But medical professionals had concerns.

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

An OB-GYN suggested that this may have been part of the cause why the drug was not originally approved for older females.

“There have been adverse reactions like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

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

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

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

“I believe it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a quick fix. In fact, the experts interviewed all agreed that the female libido is influenced by many factors.

So addressing low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a broad range of changes that can affect libido. Symptoms of menopause encompass:

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

According to one expert, managing these symptoms is often a first step toward sexual wellness.

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less apprehensive about it and to consider it as a treatment option.

Androgen therapy is also sometimes used without formal approval to address reduced desire in women, although it is not officially approved for it.

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

“I am comfortable recommending Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing sexual desire include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter 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 OB-GYN. “This involves understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of orgasm.”