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The federal agency expanded its approval of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to include women after menopause up to 65 years old.

Prior to the recent news, the pill, Addyi (flibanserin), was solely authorized to treat low sexual desire in women of reproductive age.

This medication was first approved by the FDA in 2015, following a lengthy and contentious review process.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency cited issues about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of flibanserin applauded the FDA’s move to broaden the drug’s approval, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other women’s health experts voiced approval for the regulatory move.

“There was nothing 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 patient population could be crucial to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A professor of obstetrics and gynecology told reporters that the approval was “logical” given the clinical evidence.

Although supportive, the expert was guarded in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the magnitude of the improvement is not dramatic. Does it justify taking a drug every single day and not getting bang for your buck?”

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

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the medication from which it gets its informal name.

This medication was initially researched as an medication for depression but was considered unsuccessful during early studies.

However, scientists noted positive changes in aspects of libido and arousal and shifted focus to the drug’s potential as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable lobbying effort.

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

Official guidance advises allowing a two-hour gap after drinking before using the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no additional risk of syncope. But experts had concerns.

“This research aren't very convincing 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 gynecologist suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“There have been adverse reactions like the syncopal episodes and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed uncertainty about why the broader approval 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 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 clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand treatment options for HSDD to a new population of females who may benefit.

“I believe it will serve this demographic better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the experts consulted all agreed that the women's sexual desire is complex and multifaceted.

So treating HSDD means considering everything from relationship dynamics to hormonal changes.

Women after menopause navigate a broad range of symptoms that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

According to one expert, managing these issues is often a first step toward improved intimacy.

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

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

She hopes that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less apprehensive about it and to consider it as a treatment option.

Testosterone is also sometimes prescribed off-label 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 considered. Conversations about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem prescribing Addyi 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
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and this life stage in older age,” said an expert. “That means understanding how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of sexual pleasure.”