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U.S. regulators broadened the authorized use of a daily pill to address low libido in women to now encompass postmenopausal women up to 65 years old.

Before the announcement, the pill, Addyi (flibanserin), was exclusively cleared to address low sexual desire in women of reproductive age.

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

The FDA previously rejected the drug on two separate occasions, in 2010 and 2013. In both cases, the agency raised concerns about safety, effectiveness, and an unfavorable risk–benefit profile.

Currently, Addyi is the exclusive pill authorized for HSDD, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in 2019.

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s decision to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Other specialists in female health were supportive for the regulatory move.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this group of women could be crucial to help postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

A clinical professor told reporters that the approval was “quite reasonable” given the clinical evidence.

Although supportive, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the benefit is not overwhelming. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

Understanding Flibanserin, the ‘Women's Desire Pill’?

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

The drug was first created as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, scientists observed improvements in aspects of libido and arousal and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

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

The label advises waiting at least two hours after drinking before using the drug to minimize the risk of fainting. If a person consumes three or more alcoholic drinks on a given day, the instructions recommends not taking the pill entirely.

Assertions about the interactions of combining Addyi and alcohol eventually prompted the pharmaceutical company to fund additional studies examining the combination. The research, which were limited in size, 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 large-scale and certainly aren’t very long,” a public health expert stated.

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

“Patients have experienced adverse reactions like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of treatment. When you get older, you become more susceptible to things like that,” she said.

Another doctor expressed confusion about why the broader approval was capped at age 65.

“I don’t know if that has to do with the complexity of the medication. If you take 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 simpler guidance because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for low desire to a new population of women who may benefit.

“I do think it will serve this demographic better as long as they have no other health issues,” said an specialist.

But it is not a simple solution. In fact, the experts interviewed universally acknowledged that the female libido is influenced by many factors.

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

Women after menopause navigate a wide variety of symptoms that can affect libido. Symptoms of menopause include:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with concerns about desire, my initial inquiry 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 effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “black box” 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 occasionally used without formal approval to address reduced desire in females, although it is not officially approved for it.

But besides medication, experts say that personal habits should also be factored in. Discussions about libido almost always start with relationships and intimacy.

“I am comfortable recommending Addyi 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 sexual desire are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter lubricants
• practicing extended intimate stimulation
• incorporating vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “That means knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”