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The Food and Drug Administration (FDA) widened the indication of a daily pill to address low libido in females to include women after menopause up to age 65.

Before the recent news, the drug, Addyi (flibanserin), was solely authorized to address low sexual desire in premenopausal females.

This medication was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial review process.

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

Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of flibanserin applauded the FDA’s action to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional specialists in female health expressed support for the regulatory move.

“There was nothing for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be crucial 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 decision was “logical” given the existing research.

While in favor, the expert was measured in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the enhancement is not dramatic. Is it worthwhile taking a drug every single day and not experiencing a dramatic change?”

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

Addyi, 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.

The drug was initially researched as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for severe side effects, including low blood pressure (hypotension) and loss of consciousness, when taken alongside alcohol.

The label recommends waiting at least two hours after consuming alcohol before taking Addyi to reduce the chance of syncope. If a person has several drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually led the maker to fund further research investigating the combination. The studies, which were small in scale, demonstrated no additional risk of fainting. But experts had reservations.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An gynecologist speculated that this may have been part of the cause why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness 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 things like that,” she said.

Another doctor expressed confusion about why the expanded indication was limited at 65 years of age.

“It's unclear if that has to do with the complexity of the medication. Reviewing a list of the instructions and restrictions, it’s really wide-ranging. 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 Low Libido After Menopause

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

“I believe it will serve this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a quick fix. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

So treating HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of changes that can affect sexual desire. Menopausal symptoms encompass:

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

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

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

The expert recommended both vaginal estrogen and systemic hormone therapy as options to alleviate the effects of menopause, particularly vaginal dryness.

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more females to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also occasionally prescribed off-label to address 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. Conversations about libido almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for increasing sexual desire are:

• getting more sleep
• engaging in physical activity
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating sexual wellness devices or vaginal dilators

“It requires an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “That means knowing how your body works, your anatomy, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”