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

Before the recent news, the pill, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was initially cleared by the FDA in two thousand fifteen, following a long and debated review process.

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

Today, flibanserin is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an as-needed injectable treatment, in two thousand nineteen.

The chief executive of the maker of flibanserin commended the FDA’s action to expand the drug’s approval, calling it a “landmark event” in advancing and focusing on women's sexual wellness.

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

“There was nothing for me to recommend because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA approval for this patient population could be very important to address postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

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

Although supportive, the expert was guarded in her evaluation: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “the women's version of Viagra,” has significant differences with the drug from which it draws its nickname.

The drug was initially researched as an antidepressant but was found to be lacking during early studies.

Nevertheless, researchers noted improvements in aspects of libido and arousal and shifted focus to the drug’s potential as a treatment for diminished sexual desire.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a significant advocacy campaign.

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

The label recommends waiting at least two hours after consuming alcohol before using the drug to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends not taking the pill entirely.

Assertions about the interactions of mixing Addyi and alcohol eventually led the pharmaceutical company to fund additional studies examining the interaction. The research, which were limited in size, showed no increased danger of fainting. But medical professionals had reservations.

“These studies 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 speculated that this may have been part of the reason why the drug was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes and dizziness 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 expressed uncertainty about why the broader approval was limited at age 65.

“I don’t know if that has to do with the complexity of the drug. If you take a list of the dos and don’ts, it’s really wide-ranging. Now that this has been cleared, they need to come out with an clearer instructions because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Despite these risks, flibanserin could still expand treatment options for HSDD to a new population of females who may benefit.

“I believe it will benefit this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a magic bullet. In fact, the experts consulted all agreed that the female libido is complex and multifaceted.

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

Postmenopausal females navigate a wide variety of changes that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

According to one expert, managing these symptoms 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 suggested both vaginal estrogen and hormone replacement therapy (HRT) as treatments to alleviate 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 women to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also occasionally prescribed off-label to treat reduced desire 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 having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Additional recommendations for boosting libido are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating sexual wellness devices or dilators

“It requires an entire whole body approach to sexual health and this life stage in later life,” said an OB-GYN. “This involves understanding how your body works, your anatomy, 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.”