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U.S. regulators broadened the authorized use of a once-a-day medication to manage low libido in women to include women after menopause up to age 65.

Prior to the announcement, the drug, flibanserin (Addyi), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

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

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

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

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 female sexual health.

Other women’s health experts were supportive for the regulatory move.

“Previously, options were limited for me to recommend because available treatments was for women who were premenopausal and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be crucial to address women after menopause who wish to engage in sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the decision was “quite reasonable” given the available data.

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed a meaningful difference of the drug over the placebo, but the extent of the improvement is not substantial. Is it worthwhile taking a drug daily and not seeing a major effect?”

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

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

The drug was first created as an medication for depression but was found to be lacking during early studies.

Nevertheless, researchers observed positive changes in measures of sexual function and redirected efforts to the drug’s potential as a treatment for low libido.

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

The medication carries a boxed (“black box”) warning for potentially dangerous adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

Official guidance advises waiting at least two hours after drinking before taking the drug to reduce the chance of syncope. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

Claims about the interactions of mixing Addyi and alcohol eventually led the maker to fund further research investigating the combination. The studies, which were small in scale, showed no additional risk of fainting. But experts 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 health research president stated.

An gynecologist speculated 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 persons who have had an drink within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said.

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

“It's unclear if that has to do with the intricacies of the drug. Reviewing 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 easier information sheet because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand treatment options for low desire to a new population of females who may benefit.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an OB-GYN.

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

So addressing low desire means considering everything from relationship dynamics to hormonal changes.

Women after menopause experience a broad range of symptoms that can impact libido. Symptoms of menopause encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“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 recommended both topical estrogen therapy and systemic hormone therapy as treatments to treat the symptoms of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “black box” warning on HRT will lead more women to feel less concerned about it and to view it as a viable choice.

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

But in addition to drugs, doctors say that lifestyle should also be considered. Conversations about sexual desire almost always start with relationships and intimacy.

“I am comfortable prescribing Addyi 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 libido are:

• improving sleep hygiene
• exercising
• maintaining an active lifestyle
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• using vibrators or dilators

“It requires an entire whole body approach to sexual health and this life stage in older age,” said an expert. “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 excited, and ultimately to have a peak of orgasm.”