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U.S. regulators broadened the authorized use of a once-a-day medication to treat low libido in females to include postmenopausal women up to age 65.

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

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

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

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

Other OB-GYNs expressed support for the decision.

“There was nothing for me to recommend because everything was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the available data.

While in favor, the expert was cautious in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the extent of the improvement is not substantial. Does it justify taking a drug daily and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

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

The drug was first created as an antidepressant but was deemed ineffective during initial trials.

Nevertheless, scientists observed positive changes in measures of libido and arousal and redirected efforts to the drug’s possible use as a therapy for low libido.

Following initial denials, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a significant lobbying effort.

Addyi carries a boxed (“black box”) warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when combined with alcoholic drinks.

Official guidance recommends allowing a two-hour gap after drinking before using the drug to reduce the chance of fainting. If a person consumes several drinks on a given day, the label advises skipping the dose entirely.

Claims about the effects of combining the drug with drinking eventually prompted the maker to fund additional studies examining the combination. The research, which were small in scale, showed no additional risk of fainting. But medical professionals had concerns.

“This research don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

An gynecologist speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“There have been adverse reactions like the fainting spells and dizziness especially in individuals who have had an drink 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 capped at age 65.

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

Addressing Low Libido in Postmenopausal Women

Despite these risks, Addyi could still expand therapeutic choices for low desire to a new population of women who may find help.

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

But it is not a quick fix. In fact, the specialists interviewed all agreed 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.

Postmenopausal females navigate a broad range of symptoms that can impact libido. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms is often a first step toward sexual wellness.

“If somebody came to me 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 systemic hormone therapy as options to alleviate the effects of menopause, particularly dryness.

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

Androgen therapy is also sometimes prescribed off-label to address low libido in women, although it is not officially approved for it.

But in addition to drugs, doctors say that personal habits should also be considered. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I am comfortable 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.

Additional recommendations for increasing libido are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexuality and menopause in later life,” said an OB-GYN. “That means knowing 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 climax of sexual pleasure.”