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The federal agency expanded its approval of a oral treatment to treat low libido in women to cover women after menopause up to the age of sixty-five.

Before the announcement, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was first approved by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the maker of flibanserin applauded the FDA’s move to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional women’s health experts expressed support for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be crucial to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

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

While in favor, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the benefit is not overwhelming. Does it justify taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Women's Desire Pill’?

Addyi, which is often called “female Viagra,” has little in common with the drug from which it draws its nickname.

This medication was first created as an antidepressant but was deemed ineffective during initial trials.

However, scientists observed improvements in measures of libido and arousal and redirected efforts to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

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

The label recommends allowing a two-hour gap after drinking before using the drug to reduce the risk of fainting. If a person has three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the maker to fund additional studies examining the combination. The studies, which were limited in size, showed no increased danger of fainting. But medical professionals had concerns.

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

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

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get older, 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 complexity of the medication. Reviewing a list of the instructions and restrictions, they are extensive. 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 Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for HSDD to a new population of women who may find help.

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

But it is not a simple solution. In fact, the specialists interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

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

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

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, managing these issues is often a initial approach 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 options to alleviate the symptoms of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also sometimes used without formal approval to treat low libido in females, although it is not indicated for it.

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

“I would have no problem prescribing Addyi 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.

Other recommendations for boosting libido are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an expert. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of orgasm.”