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The Food and Drug Administration (FDA) broadened the authorized use of a oral treatment to treat hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to the age of sixty-five.

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

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

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency cited issues about its safety profile, efficacy, 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 bremelanotide (Vyleesi), an injectable used when desired, in two thousand nineteen.

The chief executive of the maker of Addyi praised the FDA’s decision to broaden the drug’s approval, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other women’s health experts voiced approval for the decision.

“There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be crucial to address postmenopausal women who wish to engage in sexual activity and experience pleasure, but sometimes have problems regarding libido.”

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

While in favor, the expert was measured in her evaluation: “Clinical trials showed a meaningful difference of the drug over the inactive pill, but the magnitude of the improvement is not dramatic. Is it worthwhile taking a drug every single day and not seeing a major effect?”

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

Flibanserin, which is often called “the women's version of Viagra,” has few similarities with the medication from which it gets its informal name.

The drug was originally developed as an antidepressant but was found to be lacking during initial trials.

However, scientists observed improvements in aspects of libido and arousal and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a significant advocacy campaign.

Addyi carries a serious safety warning for serious adverse reactions, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

The label advises allowing a two-hour gap after drinking before using Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the instructions recommends skipping the dose entirely.

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

“These studies aren't very persuasive to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An gynecologist suggested that this may have been part of the cause why the drug was not initially cleared for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness 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 effects like that,” she said.

Another doctor expressed uncertainty about why the broader approval was capped at 65 years of age.

“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, they are extensive. Now that this has been cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

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

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

But it is not a quick fix. In fact, the experts interviewed all agreed that the women's sexual desire is complex and multifaceted.

So treating low desire means engaging with everything from relationship dynamics to hormonal changes.

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

• sudden feelings of heat
• lack of natural lubrication
• discomfort with sex
• insomnia
• 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 first question is: How’s your vagina feeling? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and systemic hormone therapy as treatments to alleviate the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a treatment option.

Androgen therapy is also occasionally used without formal approval to address reduced desire in females, although it is not indicated for it.

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

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

Other suggestions for increasing libido are:

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

“It requires an comprehensive, holistic strategy to sexuality and menopause in later life,” 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 aroused, and ultimately to have a climax of sexual pleasure.”