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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to include postmenopausal women up to 65 years old.

Before this week's decision, the pill, Addyi (flibanserin), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was first approved by the FDA in 2015, following a protracted and controversial evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the maker of Addyi applauded the FDA’s move to broaden the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Other specialists in female health were supportive for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be very important to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding 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 evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the degree of the improvement is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was deemed ineffective during initial trials.

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

Following initial denials, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant advocacy campaign.

Addyi carries a serious safety warning for serious side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the risk of fainting. If a person has several drinks on a given day, the label advises not taking the pill entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the interaction. The research, which were limited in size, showed no additional risk of syncope. But medical professionals had concerns.

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

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

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

Another doctor expressed confusion about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. Reviewing a list of the dos and don’ts, it’s really wide-ranging. 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 Low Libido After Menopause

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for HSDD to a different group of females who may find help.

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

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 engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a broad range of changes that can impact libido. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, managing these symptoms is often a initial approach toward sexual wellness.

“When a patient presents with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as options to alleviate the effects of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a viable choice.

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. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing Addyi after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing libido are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an OB-GYN. “That means knowing how your body works, your anatomy, 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.”