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The federal agency broadened the authorized use of a once-a-day medication to treat low libido in females to now encompass women after menopause up to the age of sixty-five.

Before the announcement, the drug, flibanserin (Addyi), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was initially cleared by the FDA in 2015, following a long and debated evaluation period.

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

Today, flibanserin is the sole oral drug cleared by the FDA for HSDD, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

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

Additional OB-GYNs voiced approval for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were menstrual 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 issues with libido.”

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

While in favor, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not overwhelming. Does it justify taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has little in common with the medication from which it gets its informal name.

This medication was originally developed as an medication for depression but was considered unsuccessful during initial trials.

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

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

The medication carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

The label advises allowing a two-hour gap after consuming alcohol before taking the drug to minimize the risk of syncope. If a person consumes several drinks on a single occasion, the instructions recommends not taking the pill entirely.

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

“This research don’t seem very persuasive 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 speculated that this may have been part of the reason why Addyi was not initially cleared for older females.

“Patients have experienced side effects 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 susceptible to effects 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 complexity of the medication. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Despite these risks, Addyi could still broaden treatment options for HSDD to a different group of women who may find help.

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

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

So addressing low desire means considering everything from relationship dynamics to hormonal changes.

Postmenopausal females experience a wide variety of changes that can impact libido. Menopausal symptoms encompass:

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

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

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

The expert recommended both topical estrogen therapy and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a treatment option.

Androgen therapy 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, experts say that personal habits should also be factored in. Discussions about sexual desire almost always start with relationships and intimacy.

“I am comfortable recommending flibanserin after having a conversation with a patient. But I would also advise them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing libido are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter lubricants
• practicing extended foreplay
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “This involves 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 peak of orgasm.”