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The Food and Drug Administration (FDA) expanded its approval of a daily pill to manage hypoactive sexual desire disorder (HSDD) in females to now encompass women after menopause up to 65 years old.

Before the recent news, the drug, flibanserin (Addyi), was only approved to treat low sexual desire in women of reproductive age.

The drug was first approved by the FDA in 2015, following a lengthy and contentious evaluation period.

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the FDA cited issues about safety, efficacy, 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 as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin praised the FDA’s move to expand the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Additional OB-GYNs expressed support for the regulatory move.

“I had few tools for me to recommend 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 postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

Although supportive, the expert was measured in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the degree of the improvement is not dramatic. Does it justify taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

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

However, scientists observed positive changes in measures of sexual function and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

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

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

Official guidance recommends waiting at least two hours after drinking before using Addyi to minimize the risk of fainting. If a person has several drinks on a single occasion, the label advises not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund further research investigating the combination. The studies, which were small in scale, showed no additional risk of fainting. But experts had reservations.

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

An OB-GYN speculated that this may have been part of the cause why the drug was not originally approved for older females.

“There have been adverse reactions like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to things like that,” she said.

Another doctor echoed uncertainty about why the broader approval was limited at age 65.

“It's unclear if that has to do with the intricacies of the medication. 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 prescribing,” he said.

Treating Low Libido After Menopause

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

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

But it is not a quick fix. In fact, the experts consulted universally acknowledged that the women's sexual desire is influenced by many factors.

So addressing HSDD means engaging with everything from relationship dynamics to shifts in hormone levels.

Women after menopause navigate a wide variety of symptoms that can affect libido. Menopausal symptoms include:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• insomnia
• urinary incontinence

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

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

The expert suggested both topical estrogen therapy and hormone replacement therapy (HRT) as options to alleviate the symptoms of menopause, particularly 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 view it as a viable choice.

Androgen therapy is also occasionally prescribed off-label to treat low libido in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be factored in. Discussions about sexual desire almost always start with relationships and intimacy.

“I am comfortable prescribing flibanserin after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for boosting libido are:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in later life,” said an OB-GYN. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a climax of sexual pleasure.”