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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 cover women after menopause up to the age of sixty-five.

Prior to the recent news, the drug, flibanserin (Addyi), was exclusively cleared to address low sexual desire in women of reproductive age.

This medication was initially cleared by the FDA in 2015, following a long and debated evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of flibanserin praised the FDA’s move to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other specialists in female health voiced approval for the decision.

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be significant to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the decision was “logical” given the existing research.

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

What is 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 gets its informal name.

The drug was originally developed as an antidepressant but was deemed ineffective during early studies.

However, scientists noted improvements in aspects of libido and arousal and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

Addyi carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

Official guidance recommends allowing a two-hour gap after consuming alcohol before taking Addyi to minimize the chance of syncope. If a person consumes several drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had reservations.

“These studies don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” a health research president stated.

An OB-GYN speculated that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“There have been adverse reactions like the fainting spells and lightheadedness especially in persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more sensitive to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. If you take 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 simpler guidance because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a different group of females who may benefit.

“I believe it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

But it is not a magic bullet. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females experience a broad range of symptoms that can impact sexual desire. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

As noted by one expert, managing these issues is often a first step toward sexual wellness.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as options to treat the symptoms of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more females to feel less concerned about it and to view it as a viable choice.

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

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about libido almost always start with partnership dynamics and closeness.

“I would have no problem recommending Addyi after having a conversation with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting libido include:

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

“You have to take an entire whole body approach to sexual health and this life stage in later life,” said an expert. “This involves understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of orgasm.”