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The Food and Drug Administration (FDA) widened the indication of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to age 65.

Prior to the recent news, the medication, Addyi (flibanserin), was exclusively cleared to address low sexual desire in premenopausal females.

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

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In both cases, the agency expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, Addyi is the exclusive pill authorized for HSDD, though the FDA approved bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s move to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

Other OB-GYNs voiced approval for the regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be very important to address 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 approval was “quite reasonable” given the existing research.

Although supportive, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not overwhelming. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was first created as an antidepressant but was deemed ineffective during initial trials.

Nevertheless, scientists observed positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

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

Addyi carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcoholic drinks.

The label recommends allowing a two-hour gap after consuming alcohol before using 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.

Claims about the interactions of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the combination. The studies, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had reservations.

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

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

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

Another doctor echoed confusion about why the expanded indication was capped at age 65.

“I don’t know if that has to do with the intricacies of the drug. If you take a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for HSDD 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 specialist.

But it is not a simple solution. In fact, the experts interviewed universally acknowledged that the female libido is complex and multifaceted.

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

Postmenopausal females navigate a wide variety of changes that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a initial approach toward improved intimacy.

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also occasionally used without formal approval to treat low libido in females, although it is not indicated for it.

But besides medication, doctors say that personal habits should also be considered. Conversations about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for boosting libido include:

• getting more sleep
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an expert. “That means 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.”