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The Food and Drug Administration (FDA) widened the indication of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to 65 years old.

Prior to the recent news, the drug, Addyi (flibanserin), was only approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin was first approved by the FDA in two thousand fifteen, following a protracted and controversial regulatory scrutiny.

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 safety, efficacy, and an unfavorable risk–benefit profile.

Now, flibanserin is the only FDA-approved oral medication for HSDD, though the FDA approved Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the maker of Addyi applauded the FDA’s decision to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs voiced approval for the decision.

“Previously, options were limited for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an OB-GYN. “Getting the FDA clearance 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 clinical professor told reporters that the decision was “understandable” given the existing research.

Although supportive, the expert was guarded in her assessment: “The studies showed a meaningful difference of the drug over the placebo, but the extent of the benefit is not substantial. 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 sometimes referred to as “the women's version of Viagra,” has significant differences with the medication from which it draws its nickname.

This medication was originally developed as an medication for depression but was deemed ineffective during initial trials.

However, researchers observed positive changes in measures of libido and arousal and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

After two rejections, Addyi was approved in 2015 to treat HSDD, following additional research and a considerable lobbying effort.

The medication carries a serious safety warning for serious side effects, including a drop in blood pressure and fainting (syncope), when taken alongside alcoholic drinks.

The label recommends allowing a two-hour gap after consuming alcohol before using Addyi to reduce the risk of syncope. If a person consumes three or more alcoholic drinks on a given day, the label advises not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually prompted the maker to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“These studies aren't very convincing to me. They are a good start, but they’re not very large-scale and certainly are short-term,” a public health expert stated.

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

“Patients have experienced side effects like the fainting spells and lightheadedness especially in individuals who have had an alcoholic beverage within two hours of treatment. When you get older, you become more sensitive to effects like that,” she said.

Another doctor expressed confusion about why the broader approval was capped at age 65.

“I don’t know if that has to do with the complexity of the drug. Reviewing a list of the dos and don’ts, they are extensive. Now that this has been cleared, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for HSDD to a different group of females who may benefit.

“I do think it will serve this population better as long as they have no other health issues,” said an specialist.

But it is not a magic bullet. In fact, the experts interviewed universally acknowledged that the women's sexual desire is complex and multifaceted.

So addressing low desire means engaging with everything from relationship dynamics to shifts in hormone levels.

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

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• bladder leakage

As noted by one expert, managing 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? Are you comfortable?” she said.

The expert suggested both vaginal estrogen and hormone replacement therapy (HRT) as options to treat the symptoms of menopause, particularly dryness.

She hopes that the regulatory decision to lift of its “serious” warning on hormone therapy will lead more females to feel less apprehensive about it and to view it as a treatment option.

Testosterone is also sometimes used without formal approval to address low libido in females, although it is not indicated for it.

But besides medication, experts say that personal habits should also be considered. Discussions about libido almost always begin by focusing on relationships and intimacy.

“I am comfortable recommending flibanserin 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.

Additional suggestions for increasing libido are:

• improving sleep hygiene
• engaging in physical activity
• staying active
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• using vibrators or vaginal dilators

“It requires an comprehensive, holistic strategy to sexuality and menopause in older age,” said an expert. “This involves understanding how your body works, your anatomy, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a climax of sexual pleasure.”