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The Food and Drug Administration (FDA) expanded its approval of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to the age of sixty-five.

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

The drug was first approved by the FDA in 2015, following a long and debated review process.

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, Addyi is the sole oral drug cleared by the FDA for HSDD, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

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

Other OB-GYNs 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 menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to address women after menopause who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

While in favor, the expert was cautious in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not dramatic. Does it justify taking a drug daily and not seeing a major effect?”

What is Flibanserin, the ‘Women's Desire Pill’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has little in common with the drug from which it draws its nickname.

This medication was originally developed as an antidepressant but was found to be lacking during initial trials.

Nevertheless, scientists observed improvements in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a major advocacy campaign.

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

Assertions about the effects of mixing Addyi and alcohol eventually prompted the maker to fund additional studies examining the combination. The studies, which were limited in size, showed no additional risk of syncope. But medical professionals had concerns.

“This research don’t seem 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 originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells 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 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. If you take a list of the dos and don’ts, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden therapeutic choices for low desire to a different group of females who may find help.

“I believe it will serve this population 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 consulted all agreed that the female libido is influenced by many factors.

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

Women after menopause experience a wide variety of symptoms that can affect sexual desire. Symptoms of menopause encompass:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

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

The expert recommended both topical estrogen therapy and hormone replacement therapy (HRT) as treatments to treat the effects of menopause, particularly vaginal dryness.

She hopes that the regulatory decision to lift of its “black box” warning on HRT will lead more females to feel less concerned about it and to consider it as a viable choice.

Androgen therapy is also sometimes used without formal approval to treat reduced desire in females, although it is not officially approved for it.

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

“I am comfortable prescribing Addyi 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.

Other recommendations for boosting libido are:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or vaginal dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “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 climax of sexual pleasure.”