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The Food and Drug Administration (FDA) widened the indication of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in females to now encompass postmenopausal women up to the age of sixty-five.

Prior to the recent news, the medication, Addyi (flibanserin), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was first approved by the FDA in 2015, following a long and debated review process.

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

Today, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of flibanserin praised the FDA’s move to broaden the drug’s indication, calling it a “milestone” in understanding and prioritizing women's sexual wellness.

Additional OB-GYNs expressed support for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be significant to help 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 “understandable” given the existing research.

While in favor, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the placebo, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug daily and not getting bang for your buck?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was initially researched as an medication for depression but was considered unsuccessful during initial trials.

However, researchers noted improvements in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was cleared in 2015 to treat HSDD, following additional research and a significant lobbying effort.

The medication carries a serious safety warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when combined with alcohol.

Official guidance advises waiting at least two hours after drinking before taking Addyi to reduce the chance of syncope. If a person has several drinks on a single occasion, the label advises not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually prompted the pharmaceutical company to fund further research examining the combination. The studies, which were limited in size, showed no increased danger of fainting. But experts had reservations.

“These studies don’t seem very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An OB-GYN suggested that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“There have been adverse reactions like the syncopal episodes and lightheadedness especially in persons who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was capped at 65 years of age.

“It's unclear 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 approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still expand treatment options for low desire to a different group of women who may benefit.

“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 specialists consulted universally acknowledged that the female libido is influenced by many factors.

So treating low desire means engaging with everything from partnership issues to shifts in hormone levels.

Postmenopausal females navigate a wide variety of changes that can impact sexual desire. Symptoms of menopause encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

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

“When a patient presents with concerns about desire, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both vaginal estrogen and hormone replacement therapy (HRT) as options to alleviate the symptoms of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift 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 used without formal approval to address reduced desire in females, although it is not officially approved for it.

But besides medication, doctors say that personal habits should also be considered. Discussions about libido 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.

Additional suggestions for boosting libido include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• engaging in extended foreplay
• using sexual wellness devices or vaginal dilators

“You have to take an entire whole body approach to sexual health and this life stage in older age,” said an OB-GYN. “That means understanding how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”