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U.S. regulators widened the indication of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to age 65.

Prior to the recent news, the pill, Addyi (flibanserin), was only approved to treat low sexual desire in women of reproductive age.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency raised concerns about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

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

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

Additional OB-GYNs were supportive for the decision.

“I had few tools for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Getting the FDA approval for this group of women could be crucial to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the existing research.

Although supportive, the expert was measured in her evaluation: “Clinical trials 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 seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has little in common with the medication from which it gets its informal name.

The drug was first created as an medication for depression but was deemed ineffective during initial trials.

However, scientists noted positive changes in measures of sexual function and shifted focus to the drug’s potential as a treatment for low libido.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

The medication carries a boxed (“black box”) warning for serious adverse reactions, 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 Addyi to reduce the chance of syncope. If a person has several drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The research, which were small in scale, demonstrated no additional risk of fainting. But experts had concerns.

“This research aren't very persuasive 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 reason why the drug was not initially cleared for older females.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more sensitive to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, Addyi could still expand treatment options for HSDD to a new population of women who may find help.

“I believe it will benefit this population better as long as they have no other health issues,” said an specialist.

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

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

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

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward sexual wellness.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope 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 view it as a treatment option.

Testosterone is also sometimes used without formal approval to treat reduced desire in women, although it is not indicated for it.

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

“I would have no problem prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using vibrators or dilators

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an expert. “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 climax of sexual pleasure.”