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The Food and Drug Administration (FDA) widened the indication of a oral treatment to address hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to the age of sixty-five.

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

This medication was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In each instance, the agency raised concerns about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, 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 chief executive of the pharmaceutical company of Addyi praised the FDA’s decision to expand the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Other OB-GYNs voiced approval for the decision.

“There was nothing for me to prescribe because everything was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this group of women could be significant to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “logical” given the available data.

Although supportive, the expert was cautious in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

Flibanserin, which is often called “female Viagra,” has significant differences with the drug from which it gets its informal name.

The drug was first created as an medication for depression but was considered unsuccessful during early studies.

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, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before using Addyi to minimize the risk of fainting. If a person has several drinks on a given day, the label advises skipping the dose entirely.

Claims about the effects of mixing Addyi and alcohol eventually led the maker to fund additional studies examining the combination. The research, which were small in scale, showed no increased danger of fainting. But experts had concerns.

“This research don’t seem very convincing 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 cause why Addyi was not originally approved for older females.

“There have been adverse reactions like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage 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 uncertainty about why the expanded indication was capped 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 instructions and restrictions, it’s really wide-ranging. 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 Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire to a different group of women who may find help.

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

But it is not a quick fix. In fact, the specialists consulted universally acknowledged that the women's sexual desire 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 affect sexual desire. Menopausal symptoms include:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“When a patient presents with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to view it as a viable choice.

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

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

“I would have no problem recommending 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 sexual desire include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause in later life,” said an OB-GYN. “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 excited, and ultimately to have a peak of sexual pleasure.”