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

Before this week's decision, the drug, flibanserin (Addyi), was exclusively cleared to treat low sexual desire in premenopausal females.

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

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In each instance, the agency expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Today, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in 2019.

The chief executive of the maker of flibanserin commended the FDA’s move to expand the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other OB-GYNs voiced approval for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be significant to address postmenopausal women 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 approval was “understandable” given the existing research.

Although supportive, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the placebo, but the extent of the improvement is not substantial. Does it justify taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was originally developed as an antidepressant but was found to be lacking during early studies.

However, scientists noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a major advocacy campaign.

The medication carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

Official guidance recommends waiting at least two hours after consuming alcohol before taking Addyi to reduce the chance of syncope. If a person has several drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually led the maker to fund further research investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of fainting. But medical professionals had concerns.

“This research aren't very persuasive to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

An OB-GYN speculated that this may have been part of the reason why Addyi was not originally approved for older females.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness especially in persons 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 echoed 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 drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been approved, 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, flibanserin could still broaden treatment options for low desire to a new population of women who may benefit.

“I do think it will serve this demographic 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 consulted universally acknowledged that the female libido is influenced by many factors.

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

Women after menopause navigate a wide variety of symptoms that can impact sexual desire. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• insomnia
• bladder leakage

According to one expert, managing these issues is often a initial approach toward sexual wellness.

“When a patient presents with libido issues, my first question 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 effects of menopause, particularly dryness.

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

Androgen therapy is also sometimes prescribed off-label to address low libido in women, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be considered. Discussions about libido almost always start with partnership dynamics and closeness.

“I am comfortable prescribing flibanserin 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 boosting sexual desire include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “This involves knowing how your body works, your physiology, 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 sexual pleasure.”