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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to treat low libido in women to include women after menopause up to age 65.

Before the recent news, the pill, flibanserin (Addyi), was exclusively cleared to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was initially cleared by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

Regulators had earlier turned down 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.

Currently, flibanserin is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in 2019.

The founder and CEO of the maker of Addyi praised the FDA’s action to expand the drug’s indication, calling it a “landmark event” in advancing and focusing on female sexual health.

Additional OB-GYNs were supportive for the decision.

“There was nothing for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to address postmenopausal women who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

While in favor, the expert was cautious in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the magnitude of the enhancement is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

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

This medication was first created as an medication for depression but was found to be lacking during initial trials.

However, scientists observed positive changes in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

The label advises waiting at least two hours after consuming alcohol before using the drug to reduce the risk of fainting. If a person consumes several drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund additional studies examining the interaction. The research, which were small in scale, showed no increased danger of syncope. But experts had concerns.

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

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to effects like that,” she said.

Another doctor echoed confusion about why the broader approval was capped at age 65.

“It's unclear 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 cleared, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, Addyi could still expand therapeutic choices for HSDD to a different group of women who may find help.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an specialist.

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

So treating HSDD means engaging with everything from partnership issues to shifts in hormone levels.

Women after menopause experience a broad range of symptoms that can affect libido. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, treating these symptoms is often a first step toward sexual wellness.

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

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

She hopes that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive about it and to consider it as a viable choice.

Androgen therapy is also sometimes used without formal approval to treat low libido in women, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Conversations about libido almost always start with relationships and intimacy.

“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.

Other suggestions for boosting libido are:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• using sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “This involves knowing 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 peak of sexual pleasure.”