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The Food and Drug Administration (FDA) widened the indication of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to 65 years old.

Prior to the recent news, the pill, Addyi (flibanserin), was solely authorized to treat low sexual desire in premenopausal females.

The drug was initially cleared by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

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

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

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s move to expand the drug’s approval, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health voiced approval for the decision.

“There was nothing for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this group of women could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “understandable” given the existing research.

While in favor, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

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

This medication was first created as an antidepressant but was found to be lacking during early studies.

Nevertheless, scientists observed improvements in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

The medication carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label advises waiting at least two hours after consuming alcohol before using Addyi to reduce the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

Assertions about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund further research examining the interaction. The research, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had reservations.

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

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

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

Another doctor echoed uncertainty about why the broader approval was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire to a new population of females who may find help.

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

But it is not a quick fix. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females experience a broad range of changes that can impact libido. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• urinary incontinence

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

“When a patient presents with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less concerned about it and to consider it as a treatment option.

Testosterone is also sometimes prescribed off-label to address low libido in females, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable recommending flibanserin 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.

Additional recommendations for increasing sexual desire are:

• getting more sleep
• exercising
• staying active
• using over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexual health and this life stage in later life,” said an OB-GYN. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”