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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to manage hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to the age of sixty-five.

Prior to the announcement, the medication, Addyi (flibanserin), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

The drug was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious regulatory scrutiny.

The agency had denied approval for the drug on two distinct instances, in 2010 and again in 2013. In each instance, the FDA cited issues about safety, efficacy, and an concerning balance of risks and benefits.

Currently, Addyi is the only FDA-approved oral medication for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi applauded the FDA’s action to expand the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Additional specialists in female health voiced approval for the decision.

“I had few tools for me to recommend because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance for this group of women could be crucial to address 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 approval was “understandable” given the available data.

While in favor, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the enhancement is not overwhelming. Does it justify taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the drug from which it gets its informal name.

This medication was initially researched as an antidepressant but was deemed ineffective during early studies.

However, scientists noted positive changes in aspects of libido and arousal and shifted focus to the drug’s possible use as a treatment for low libido.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a major lobbying effort.

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

Official guidance recommends waiting at least two hours after consuming alcohol before taking Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the instructions advises skipping the dose entirely.

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

“These studies aren't very convincing to me. They are a good start, but they’re not very big 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.

“There have been adverse reactions like the syncopal episodes and lightheadedness 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 expressed 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 instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, Addyi could still broaden therapeutic choices for low desire 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 health issues,” said an specialist.

But it is not a quick fix. In fact, the specialists consulted all agreed that the female libido is influenced by many factors.

So addressing low desire means considering everything from partnership issues to shifts in hormone levels.

Women after menopause navigate a broad range of symptoms that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

As noted by one expert, managing these issues is often a first step toward sexual wellness.

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

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to consider it as a viable choice.

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

But besides medication, experts say that personal habits should also be factored in. Conversations 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 encourage them to talk about some of the psychosocial issues going on,” she said.

Other recommendations for increasing libido include:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter lubricants
• engaging in extended intimate stimulation
• using 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 physiology, 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.”