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U.S. regulators expanded its approval of a daily pill to treat hypoactive sexual desire disorder (HSDD) in women to include postmenopausal women up to 65 years old.

Before the recent news, the drug, Addyi (flibanserin), was solely authorized to treat hypoactive sexual desire disorder (HSDD) in women of reproductive age.

The drug was initially cleared by the FDA in two thousand fifteen, following a long and debated evaluation period.

The agency had denied approval for the drug on two distinct instances, in 2010 and 2013. In each instance, the agency cited issues about safety, efficacy, and an concerning balance of risks and benefits.

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

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

Additional OB-GYNs were supportive for the decision.

“I had few tools for me to prescribe because available treatments 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 wish to engage in sexual activity and enjoy sex, but sometimes have issues with libido.”

A clinical professor told news outlets that the approval was “quite reasonable” given the available data.

While in favor, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the extent of the benefit is not overwhelming. Is it worthwhile taking a drug daily and not getting bang for your buck?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is often called “female Viagra,” has little in common with the medication from which it draws its nickname.

The drug was first created as an antidepressant but was found to be lacking during initial trials.

However, 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, Addyi was approved in 2015 to treat hypoactive sexual desire disorder, following further studies and a considerable advocacy campaign.

The medication carries a boxed (“black box”) warning for potentially dangerous side effects, including a drop in blood pressure and loss of consciousness, when combined with alcoholic drinks.

The label advises waiting at least two hours after consuming alcohol before using Addyi to reduce the risk of fainting. If a person has three or more alcoholic drinks on a given day, the label recommends skipping the dose entirely.

Claims about the effects of mixing Addyi and alcohol eventually prompted the maker to fund additional studies investigating the combination. The research, which were limited in size, demonstrated no additional risk of fainting. But medical professionals had reservations.

“This research aren't very convincing to me. They are a good start, but they’re not very big and certainly aren’t very long,” a public health expert stated.

An gynecologist suggested that this may have been part of the reason why Addyi was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the syncopal episodes 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 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 medication. If you take a list of the instructions and restrictions, it’s really wide-ranging. Now that this has been approved, they need to come out with an easier information sheet because it may affect our prescribing,” he said.

Treating Low Libido in Postmenopausal Women

Notwithstanding the warnings, flibanserin could still broaden treatment options for low desire to a different group of females who may find help.

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

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

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

Postmenopausal females navigate a wide variety of symptoms that can impact libido. Menopausal symptoms encompass:

• sudden feelings of heat
• vaginal dryness
• discomfort with sex
• sleep disturbances
• bladder leakage

As noted by one expert, managing these symptoms is often a first step toward improved intimacy.

“If somebody came to me with libido issues, my first question is: Are you experiencing vaginal discomfort? Are you comfortable?” she said.

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

She expressed hope that the FDA’s recent removal of its “serious” warning on HRT will lead more females to feel less concerned about it and to view it as a viable choice.

Testosterone is also sometimes used without formal approval to treat reduced desire in females, although it is not officially approved 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 prescribing 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 increasing sexual desire include:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexual health and menopause in later life,” said an OB-GYN. “That means 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 peak of orgasm.”