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U.S. regulators expanded its approval of a once-a-day medication to manage low libido in females to include women after menopause up to the age of sixty-five.

Prior to the recent news, the medication, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and again in 2013. In each instance, the agency expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

Now, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The chief executive of the maker of Addyi praised the FDA’s move to broaden the drug’s indication, calling it a “milestone” in advancing and focusing on female sexual health.

Additional specialists in female health voiced approval for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be very important to address women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told reporters that the decision was “understandable” given the existing research.

Although supportive, the expert was cautious in her assessment: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the degree of the benefit is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is often called “the women's version of Viagra,” has little in common with the drug from which it gets its informal name.

The drug was first created as an antidepressant but was found to be lacking during initial trials.

However, researchers noted positive changes in measures of libido and arousal and shifted focus to the drug’s potential as a therapy for diminished sexual desire.

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

The medication carries a serious safety warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to minimize the risk of fainting. If a person has three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund further research investigating the interaction. The research, which were small in scale, demonstrated no additional risk of syncope. But medical professionals had concerns.

“This research aren't very persuasive to me. They are a good start, 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 the drug was not initially cleared for older females.

“There have been side effects like the syncopal episodes and dizziness especially in individuals who have had an alcoholic beverage within two hours of taking the pill. When you get older, you become more susceptible to effects like that,” she said.

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

“I don’t know if that has to do with the complexity of the medication. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Addressing Low Libido in Postmenopausal Women

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

“I believe it will serve this demographic better as long as they have no other health issues,” said an OB-GYN.

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

So addressing low desire means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a wide variety of changes that can impact libido. Menopausal symptoms include:

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

According to one expert, managing these symptoms is often a first step toward improved intimacy.

“When a patient presents 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 options to treat the effects of menopause, particularly vaginal dryness.

She expressed hope that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a viable choice.

Testosterone is also sometimes prescribed off-label to address low libido in women, although it is not indicated for it.

But besides medication, doctors say that lifestyle should also be factored in. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable recommending 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 recommendations for boosting libido include:

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

“You have to take an entire whole body approach to sexuality and this life stage in later life,” said an expert. “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 aroused, and ultimately to have a climax of sexual pleasure.”