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The Food and Drug Administration (FDA) widened the indication of a oral treatment to treat low libido in women to now encompass women after menopause up to 65 years old.

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

The drug was initially cleared by the FDA in 2015, following a long and debated regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In both cases, the FDA expressed reservations about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Currently, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s move to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other women’s health experts expressed support 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 OB-GYN. “Securing the FDA approval for this patient population could be significant to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “quite reasonable” given the clinical evidence.

Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was initially researched as an antidepressant but was found to be lacking during initial trials.

Nevertheless, researchers observed positive changes in aspects of libido and arousal and redirected efforts to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, Addyi was cleared in 2015 to treat HSDD, following further studies and a major lobbying effort.

Addyi carries a serious safety warning for severe adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

Official guidance recommends allowing a two-hour gap after drinking before taking Addyi to reduce the risk of syncope. If a person has three or more alcoholic drinks on a given day, the instructions advises not taking the pill entirely.

Claims about the interactions of mixing the drug with drinking eventually led the maker to fund further research investigating the combination. The research, which were small in scale, showed no increased danger of syncope. But medical professionals had reservations.

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

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

“There have been adverse reactions like the fainting spells and dizziness especially in persons who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

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

“I don’t know 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 approved, they need to come out with an clearer instructions because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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

“I believe it will serve this demographic better as long as they have no other health issues,” said an OB-GYN.

But it is not a quick fix. 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 relationship dynamics to hormonal changes.

Postmenopausal females navigate a broad range of changes that can affect sexual desire. Symptoms of menopause include:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms is often a initial approach toward sexual wellness.

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

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

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a viable choice.

Androgen therapy is also sometimes prescribed off-label to treat reduced desire in women, although it is not indicated for it.

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

“I am comfortable recommending Addyi after discussing it with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for increasing libido include:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended foreplay
• using vibrators or dilators

“You have to take an entire whole body approach to sexual health and menopause in older age,” said an OB-GYN. “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 excited, and ultimately to have a climax of orgasm.”