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

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

Flibanserin was initially cleared by the FDA in 2015, following a lengthy and contentious regulatory scrutiny.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In both cases, the agency raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of Addyi commended the FDA’s action to expand the drug’s approval, calling it a “milestone” in understanding and prioritizing female sexual health.

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

“I had few tools for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be very important to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the approval was “understandable” given the available data.

Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the placebo, but the degree of the benefit is not dramatic. Does it justify taking a drug daily and not experiencing a dramatic change?”

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

Addyi, which is often called “female Viagra,” has significant differences with the drug from which it draws its nickname.

This medication was first created as an antidepressant but was found to be lacking during early studies.

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

After two rejections, flibanserin was approved in 2015 to treat HSDD, following further studies and a significant lobbying effort.

Addyi carries a serious safety warning for potentially dangerous side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label advises allowing a two-hour gap after drinking before taking Addyi to minimize the chance of fainting. If a person has several drinks on a single occasion, the instructions recommends skipping the dose entirely.

Assertions about the interactions of mixing the drug with drinking eventually led the pharmaceutical company to fund further research examining the combination. The studies, which were small in scale, showed no increased danger of syncope. But medical professionals had concerns.

“These studies don’t seem very persuasive to me. They are a beginning, but they’re not very large-scale and certainly aren’t very long,” 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.

“Patients have experienced 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.

“It's unclear if that has to do with the intricacies of the drug. 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 clearer instructions because it may affect our prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for low desire to a new population of females who may find help.

“I do think it will serve 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 interviewed universally acknowledged that the female libido is influenced by many factors.

So addressing low desire means considering everything from relationship dynamics to shifts in hormone levels.

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• insomnia
• bladder leakage

As noted by one expert, managing these symptoms is often a first step toward improved intimacy.

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested 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 “black box” warning on hormone therapy will lead more women to feel less concerned about it and to view it as a viable choice.

Testosterone is also occasionally used without formal approval to treat low libido in women, although it is not indicated for it.

But in addition to drugs, doctors say that personal habits should also be factored in. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable prescribing 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 boosting libido are:

• getting more sleep
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• using sexual wellness devices or dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an expert. “This involves understanding 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.”