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The federal agency broadened the authorized use of a once-a-day medication to address low libido in women to now encompass postmenopausal women up to the age of sixty-five.

Prior to the announcement, the pill, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA raised concerns about safety, efficacy, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for HSDD, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s move to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional women’s health experts voiced approval for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told news outlets that the decision was “logical” given the available data.

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the improvement is not dramatic. Does it justify taking a drug every single day and not experiencing a dramatic change?”

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

Addyi, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was originally developed as an medication for depression but was deemed ineffective during early studies.

However, researchers observed improvements in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

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

The label advises waiting at least two hours after consuming alcohol before taking Addyi to minimize the risk of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the effects of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the interaction. The studies, which were limited in size, showed no increased danger of syncope. But experts had reservations.

“This research aren't very persuasive 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 Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of treatment. When you get older, you become more sensitive to effects 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 complexity of the drug. If you take 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 clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand therapeutic choices for HSDD to a different group of females who may benefit.

“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 specialists interviewed all agreed that the female libido is complex and multifaceted.

So treating HSDD means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females navigate a broad range of symptoms that can affect libido. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• urinary incontinence

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

“If somebody came to me with concerns about desire, my initial inquiry is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as options to treat 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 women to feel less apprehensive about it and to view it as a treatment option.

Androgen therapy is also sometimes prescribed off-label to address low libido 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 relationships and intimacy.

“I would have no problem prescribing flibanserin after having a conversation 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 boosting sexual desire are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “That means knowing how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”