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The Food and Drug Administration (FDA) broadened the authorized use of a once-a-day medication to address hypoactive sexual desire disorder (HSDD) in women to now encompass postmenopausal women up to age 65.

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

Flibanserin was originally authorized by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected the drug on two separate occasions, in 2010 and again in 2013. In each instance, the FDA cited issues about its safety profile, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The founder and CEO of the maker of flibanserin praised the FDA’s action to expand the drug’s indication, calling it a “significant step” in advancing and focusing on women's sexual wellness.

Additional women’s health experts voiced approval for the decision.

“There was nothing for me to prescribe because everything was for women who were menstrual and not menopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be significant to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the available data.

While in favor, the expert was measured in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the degree of the enhancement is not substantial. Does it justify taking a drug every single day and not getting bang for your buck?”

Understanding Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has significant differences with the medication from which it draws its nickname.

The drug was originally developed as an antidepressant but was considered unsuccessful during early studies.

Nevertheless, scientists observed improvements in measures of sexual function and shifted focus to the drug’s potential as a treatment for low libido.

Following initial denials, Addyi was approved in 2015 to treat HSDD, following additional research and a significant lobbying effort.

The medication carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and loss of consciousness, when taken alongside alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before using the drug to minimize the risk of syncope. If a person consumes several drinks on a given day, the label advises not taking the pill entirely.

Assertions about the interactions of mixing the drug with drinking eventually prompted the maker to fund further research investigating the interaction. The research, which were limited in size, showed no increased danger of fainting. But experts had concerns.

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

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“Patients have experienced side effects like the fainting spells and lightheadedness especially in individuals who have had an drink within two hours of taking the pill. When you get older, you become more susceptible to things like that,” she said.

Another doctor echoed confusion about why the expanded indication was capped at age 65.

“It's unclear if that has to do with the intricacies of the drug. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a different group of women who may find help.

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

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

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

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

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“If somebody came to me with concerns about desire, my first question is: How’s your vagina feeling? Is intercourse painful?” she said.

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

She expressed hope 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 consider it as a treatment option.

Testosterone is also occasionally used without formal approval to address low libido in women, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing 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 increasing libido include:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• practicing extended foreplay
• incorporating sexual wellness devices or dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an expert. “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 aroused, and ultimately to have a climax of sexual pleasure.”