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U.S. regulators widened the indication of a daily pill to manage low libido in women to now encompass women after menopause up to age 65.

Prior to the recent news, the medication, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in premenopausal females.

Flibanserin 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 separate occasions, in 2010 and 2013. In each instance, the agency expressed reservations about safety, effectiveness, and an unfavorable risk–benefit profile.

Today, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

The founder and CEO of the maker of Addyi commended the FDA’s action to expand the drug’s indication, calling it a “significant step” in understanding and prioritizing women's sexual wellness.

Other OB-GYNs were supportive for the regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were premenopausal and not menopausal,” said an obstetrician-gynecologist. “Securing the FDA clearance for this group of women could be significant to help 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 “understandable” given the available data.

Although supportive, the expert was guarded in her evaluation: “The studies showed a meaningful difference of the drug over the placebo, but the magnitude of the enhancement is not substantial. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is often called “the women's version of Viagra,” has little in common with the medication from which it draws its nickname.

This medication was first created as an antidepressant but was considered unsuccessful during initial trials.

Nevertheless, researchers observed positive changes in measures of sexual function and redirected efforts to the drug’s possible use as a therapy for low libido.

After two rejections, flibanserin was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

Addyi carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label recommends allowing a two-hour gap after drinking before taking Addyi to reduce the risk of syncope. If a person consumes several drinks on a single occasion, the instructions advises not taking the pill entirely.

Claims about the effects of combining the drug with drinking eventually led the maker to fund additional studies investigating the interaction. The research, which were limited in size, showed no additional risk of syncope. But medical professionals had reservations.

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

An OB-GYN speculated that this may have been part of the reason why Addyi was not initially cleared for postmenopausal women.

“Patients have experienced side effects like the fainting spells and dizziness especially in persons 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 expressed confusion about why the expanded indication was limited at 65 years of age.

“It's unclear 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 clinical decisions,” he said.

Treating Low Libido After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for low desire to a different group of women who may benefit.

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

But it is not a quick fix. In fact, the experts interviewed all agreed that the female libido is complex and multifaceted.

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

Postmenopausal females experience a wide variety of changes that can affect sexual desire. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, treating these symptoms is often a initial approach toward sexual wellness.

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

The expert suggested both vaginal estrogen and systemic hormone therapy as options to treat 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 females to feel less apprehensive about it and to consider it as a treatment option.

Androgen therapy is also occasionally 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 sexual desire almost always start with partnership dynamics and closeness.

“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 sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter personal lubricants
• practicing extended foreplay
• using vibrators or dilators

“It requires an comprehensive, holistic strategy to sexual health and this life stage in older age,” said an OB-GYN. “That means knowing how your body works, your physiology, and your intimate desires — in other words, what makes you feel good, what allows you to get aroused, and ultimately to have a peak of sexual pleasure.”