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U.S. regulators widened the indication of a oral treatment to address low libido in women to now encompass postmenopausal women up to 65 years old.

Before the announcement, the pill, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was originally authorized by the FDA in two thousand fifteen, following a lengthy and contentious evaluation period.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the agency expressed reservations about safety, effectiveness, and an concerning balance of risks and benefits.

Currently, Addyi is the only FDA-approved oral medication for HSDD, though the FDA approved bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of flibanserin applauded the FDA’s action to broaden the drug’s indication, calling it a “significant step” in understanding and prioritizing female sexual health.

Additional OB-GYNs expressed support for the regulatory move.

“I had few tools for me to recommend because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be significant to address women after menopause 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 “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 placebo, but the extent of the improvement is not dramatic. Is it worthwhile taking a drug daily and not seeing a major effect?”

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

Addyi, which is sometimes referred to as “the women's version of Viagra,” has significant differences with the medication from which it gets its informal name.

The drug was initially researched as an medication for depression but was found to be lacking during initial trials.

Nevertheless, scientists observed positive changes in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for low libido.

After two rejections, flibanserin was cleared in 2015 to treat hypoactive sexual desire disorder, following additional research and a considerable lobbying effort.

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

The label advises allowing a two-hour gap after drinking before using Addyi to minimize the risk of syncope. If a person consumes several drinks on a given day, the label recommends not taking the pill entirely.

Assertions about the effects of mixing the drug with drinking 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 experts had reservations.

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

An OB-GYN suggested that this may have been part of the cause why the drug was not initially cleared for older females.

“There have been adverse reactions like the syncopal episodes and dizziness especially in persons who have had an alcoholic beverage 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 expanded indication was limited at 65 years of age.

“It's unclear if that has to do with the intricacies of the drug. Reviewing a list of the instructions and restrictions, they are extensive. Now that this has been approved, they need to come out with an easier information sheet because it may affect our clinical decisions,” he said.

Addressing Low Libido After Menopause

Notwithstanding the warnings, flibanserin could still expand treatment options for HSDD to a new population of females who may benefit.

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

But it is not a quick fix. In fact, the specialists consulted all agreed that the women's sexual desire is influenced by many factors.

So treating HSDD means considering everything from partnership issues to shifts in hormone levels.

Women after menopause experience a wide variety of changes that can impact libido. Symptoms of menopause encompass:

• hot flashes
• lack of natural lubrication
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, treating these issues is often a first step 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 recommended both topical estrogen therapy and systemic hormone therapy as treatments to alleviate the effects of menopause, particularly 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 viable choice.

Testosterone is also occasionally prescribed off-label to address low libido in females, although it is not officially approved for it.

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

“I am comfortable recommending flibanserin after having a conversation 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 boosting libido are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or dilators

“You have to take an entire whole body approach to sexuality and menopause in older age,” said an OB-GYN. “This involves understanding 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 orgasm.”