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The Food and Drug Administration (FDA) widened the indication of a daily pill to address low libido in women to include postmenopausal women up to age 65.

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

Flibanserin was originally authorized by the FDA in two thousand fifteen, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and 2013. In each instance, the agency raised concerns about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, flibanserin is the only FDA-approved oral medication 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 move to expand the drug’s indication, calling it a “landmark event” in understanding and prioritizing women's sexual wellness.

Additional specialists in female health voiced approval for the decision.

“Previously, options were limited for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this patient population could be very important to address postmenopausal women who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “quite reasonable” given the existing research.

While in favor, the expert was measured in her evaluation: “Clinical trials showed statistical significance of the drug over the placebo, but the extent of the enhancement is not substantial. Does it justify taking a drug every single day and not seeing a major effect?”

What is Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the drug from which it draws its nickname.

This medication was initially researched as an medication for depression but was found to be lacking during early studies.

Nevertheless, scientists noted positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a treatment for diminished sexual desire.

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

Addyi carries a serious safety warning for serious side effects, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

The label recommends waiting at least two hours after drinking before using the drug to reduce the chance of fainting. If a person consumes three or more alcoholic drinks on a given day, the label advises not taking the pill entirely.

Assertions about the effects of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The research, which were small in scale, showed no additional risk of syncope. But medical professionals had reservations.

“These studies don’t seem very convincing to me. They are a beginning, but they’re not very big and certainly are short-term,” a public health expert stated.

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

“There have been adverse reactions like the syncopal episodes 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 confusion about why the expanded indication was capped at age 65.

“It's unclear if that has to do with the intricacies of the medication. Reviewing a list of the dos and don’ts, it’s really wide-ranging. Now that this has been approved, they need to come out with an simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still expand treatment options for low desire to a different group of females who may find help.

“I do think it will benefit this demographic better as long as they have no other medical problems,” said an OB-GYN.

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

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

Postmenopausal females navigate a wide variety of symptoms that can affect libido. Symptoms of menopause include:

• 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 initial approach toward sexual wellness.

“When a patient presents with libido issues, my first question is: Are you experiencing vaginal discomfort? Is intercourse painful?” she said.

The expert recommended both topical estrogen therapy and systemic hormone therapy as options 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 apprehensive about it and to consider it as a treatment option.

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

But besides medication, doctors say that lifestyle should also be factored in. Discussions about sexual desire almost always start with partnership dynamics and closeness.

“I would have no problem prescribing flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Additional recommendations for increasing libido include:

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

“You have to take an comprehensive, holistic strategy to sexual health and menopause in older age,” said an OB-GYN. “That means understanding 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 peak of sexual pleasure.”