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The Food and Drug Administration (FDA) broadened the authorized use of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to include women after menopause up to age 65.

Prior to this week's decision, the drug, flibanserin (Addyi), was solely authorized to treat low sexual desire in women of reproductive age.

The drug was first approved by the FDA in two thousand fifteen, following a long and debated regulatory scrutiny.

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

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

The founder and CEO of the pharmaceutical company of Addyi applauded the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional women’s health experts expressed support for the regulatory move.

“There was nothing for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the decision was “understandable” given the clinical evidence.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.

The drug was first created as an antidepressant but was considered unsuccessful during early studies.

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

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a major lobbying effort.

The medication carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking Addyi to reduce the chance of fainting. If a person consumes several drinks on a single occasion, the instructions advises not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund further research examining the interaction. The research, which were limited in size, showed no additional risk of fainting. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly are short-term,” a health research president stated.

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

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor expressed confusion about why the expanded indication was capped at 65 years of age.

“It's unclear if that has to do with the intricacies of the medication. If you take a list of the instructions and restrictions, 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

Despite these risks, flibanserin could still expand treatment options for HSDD to a different group of females who may find help.

“I do think 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 consulted universally acknowledged that the female libido is influenced by many factors.

So treating HSDD means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause experience a broad range of symptoms that can affect libido. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these issues is often a first step toward sexual wellness.

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to treat the symptoms of menopause, particularly vaginal 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 view it as a treatment option.

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

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about libido almost always start with partnership dynamics and closeness.

“I am comfortable recommending flibanserin 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.

Additional suggestions for increasing sexual desire include:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “This involves 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 sexual pleasure.”