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The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to age 65.

Before the recent news, the pill, Addyi (flibanserin), was solely authorized 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 review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the agency expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

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

Additional specialists in female health were supportive for the decision.

“Previously, options were limited for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be crucial to help postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “understandable” given the available data.

Although supportive, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the improvement is not overwhelming. Does it justify taking a drug daily and not seeing a major effect?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is often called “the women's version of Viagra,” has few similarities with the drug from which it draws its nickname.

This medication was initially researched as an antidepressant but was considered unsuccessful during early studies.

However, researchers noted positive changes in aspects of libido and arousal and shifted focus to the drug’s possible use as a therapy for low libido.

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

The medication carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcoholic drinks.

The label recommends waiting at least two hours after drinking before taking the drug to reduce the risk of syncope. If a person has several drinks on a single occasion, the instructions advises skipping the dose entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually prompted the maker to fund additional studies investigating the interaction. The studies, which were limited in size, showed no increased danger of fainting. But experts had concerns.

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

An gynecologist suggested that this may have been part of the reason why the drug was not initially cleared for older females.

“Patients have experienced side effects like the syncopal episodes and lightheadedness especially in individuals 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 expressed uncertainty about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, it’s really wide-ranging. 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

Notwithstanding the warnings, Addyi could still broaden treatment options for low desire to a new population of females who may benefit.

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

But it is not a quick fix. In fact, the specialists consulted all agreed that the female libido is complex and multifaceted.

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

Postmenopausal females experience a wide variety of changes that can affect sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

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

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more women to feel less concerned about it and to consider it as a viable choice.

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

But besides medication, experts say that personal habits should also be factored in. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for boosting sexual desire include:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “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 aroused, and ultimately to have a climax of orgasm.”