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The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to the age of sixty-five.

Prior to this week's decision, the drug, Addyi (flibanserin), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The founder and CEO of the maker of flibanserin applauded the FDA’s action to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Other women’s health experts expressed support for the decision.

“I had few tools for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “understandable” given the clinical evidence.

Although supportive, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

Understanding Addyi, the ‘Female Viagra’?

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

The drug was initially researched as an antidepressant but was deemed ineffective during initial trials.

Nevertheless, researchers noted improvements in aspects of sexual function and redirected efforts to the drug’s possible use as a treatment for low libido.

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

The medication carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to minimize the chance of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the effects of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund further research investigating the combination. The studies, which were limited in size, demonstrated no additional risk of fainting. But experts had concerns.

“This research aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a public health expert stated.

An OB-GYN 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 persons who have had an alcoholic beverage within two hours of taking the pill. When you get more advanced in age, you become more susceptible to things like that,” she said.

Another doctor expressed uncertainty 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 medication. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still expand therapeutic choices for low desire to a new population of women who may benefit.

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

So addressing HSDD means considering everything from partnership issues to shifts in hormone levels.

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

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

According to one expert, treating these issues 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 vaginal estrogen and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly vaginal 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 concerned about it and to view it as a treatment option.

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

But besides medication, experts say that lifestyle should also be factored in. Conversations about libido almost always start with partnership dynamics and closeness.

“I am comfortable recommending 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.

Additional suggestions for increasing sexual desire are:

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

“It requires an entire whole body approach to sexual health and this life stage in older age,” said an expert. “That means understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”