🔗 Share this article

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

Prior to the recent news, the medication, Addyi (flibanserin), was only approved to treat low sexual desire in premenopausal females.

The drug was originally authorized by the FDA in 2015, following a long and debated evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about safety, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in 2019.

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s move to broaden the drug’s indication, calling it a “significant step” 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 recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the decision was “quite reasonable” given the available data.

While in favor, the expert was cautious in her evaluation: “The studies showed a meaningful difference of the drug over the inactive pill, but the magnitude of the benefit is not substantial. Is it worthwhile taking a drug daily and not experiencing a dramatic change?”

Understanding Addyi, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was initially researched as an medication for depression but was deemed ineffective during early studies.

However, scientists observed positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat HSDD, following further studies and a major advocacy campaign.

Addyi carries a serious safety warning for potentially dangerous side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcohol.

Official guidance recommends waiting at least two hours after consuming alcohol before using Addyi to reduce the chance of syncope. If a person consumes several drinks on a given day, the instructions advises skipping the dose entirely.

Assertions about the effects of combining the drug with drinking eventually led the maker to fund additional studies examining the combination. The research, which were small in scale, demonstrated no increased danger of fainting. But experts had concerns.

“This research don’t seem very persuasive to me. They are a beginning, 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 originally approved for postmenopausal women.

“There have been adverse reactions like the fainting spells and dizziness 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 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 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 clearer instructions because it may affect our clinical decisions,” he said.

Addressing Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a different group of women who may find help.

“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 quick fix. In fact, the experts consulted all agreed that the women's sexual desire is complex and multifaceted.

So treating HSDD means considering everything from relationship dynamics 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
• bladder leakage

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

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? Is intercourse painful?” she said.

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

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

Testosterone is also occasionally used without formal approval to treat low libido in women, although it is not officially approved for it.

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

“I am comfortable prescribing flibanserin after discussing it with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for boosting sexual desire are:

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

“It requires an entire whole body approach to sexuality and this life stage in older age,” said an expert. “That means understanding 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 climax of sexual pleasure.”