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The federal agency broadened the authorized use of a daily pill to address hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to the age of sixty-five.

Before the announcement, the medication, Addyi (flibanserin), was exclusively cleared to address low sexual desire in women of reproductive age.

This medication was originally authorized by the FDA in 2015, following a long and debated regulatory scrutiny.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the agency raised concerns about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of flibanserin commended the FDA’s decision to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other OB-GYNs expressed support for the regulatory move.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be crucial to address 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 approval was “understandable” given the existing research.

While in favor, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

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

The drug was first created as an medication for depression but was considered unsuccessful during early studies.

However, scientists noted improvements in aspects of libido and arousal and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable advocacy campaign.

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

The label recommends allowing a two-hour gap after consuming alcohol before taking the drug to minimize the risk of syncope. If a person has several drinks on a given day, the label recommends skipping the dose entirely.

Assertions about the effects of mixing the drug with drinking eventually led the maker to fund additional studies investigating the interaction. The research, which were small in scale, demonstrated no increased danger of syncope. But medical professionals had concerns.

“These studies don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” 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.

“There have been adverse reactions like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor echoed confusion about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the complexity of the drug. If you take a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

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

“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 specialists consulted universally acknowledged that the female libido is complex and multifaceted.

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

Women after menopause navigate a wide variety of changes that can affect sexual desire. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

According to one expert, treating these symptoms is often a first step toward improved intimacy.

“When a patient presents with libido issues, my initial inquiry is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and hormone replacement therapy (HRT) as options 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 treatment option.

Testosterone is also occasionally used without formal approval to treat reduced desire in females, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem prescribing flibanserin after having a conversation 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 increasing sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using sexual wellness devices or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “That means understanding how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”