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The federal agency broadened the authorized use of a oral treatment to manage low libido in women to cover postmenopausal women up to 65 years old.

Prior to this week's decision, the pill, flibanserin (Addyi), was solely authorized to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was first approved by the FDA in two thousand fifteen, following a long and debated evaluation period.

Regulators had earlier turned down the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of flibanserin commended the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Other women’s health experts were supportive for the regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be significant to help women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the decision was “understandable” given the existing research.

While in favor, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the extent of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “female Viagra,” has few similarities with the medication from which it gets its informal name.

The drug was originally developed as an medication for depression but was found to be lacking during early studies.

Nevertheless, researchers noted improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following further studies and a major advocacy campaign.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

The label advises waiting at least two hours after drinking before using the drug to minimize the chance of fainting. If a person consumes several drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the effects of mixing the drug with drinking eventually prompted the maker to fund further research examining the combination. The research, which were limited in size, demonstrated no additional risk of fainting. But experts had reservations.

“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 health research president stated.

An gynecologist speculated that this may have been part of the reason why Addyi was not initially cleared for older females.

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

Another doctor echoed confusion about why the expanded indication was limited at 65 years of age.

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

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

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

But it is not a magic bullet. In fact, the specialists interviewed all agreed that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to hormonal changes.

Women after menopause experience a broad range of changes that can affect sexual desire. Menopausal symptoms include:

• hot flashes
• vaginal dryness
• discomfort with sex
• insomnia
• bladder leakage

As noted by one expert, managing these symptoms 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 topical estrogen therapy and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a treatment option.

Testosterone is also sometimes used without formal approval to address low libido in females, although it is not indicated 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 flibanserin after discussing it 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 include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in older age,” said an expert. “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.”