🔗 Share this article

U.S. regulators broadened the authorized use of a daily pill to treat low libido in women to cover women after menopause up to 65 years old.

Before the announcement, the pill, flibanserin (Addyi), was only approved to treat low sexual desire in premenopausal females.

Flibanserin was first approved by the FDA in 2015, following a protracted and controversial review process.

Regulators had earlier turned down the drug on two distinct instances, in 2010 and again in 2013. In both cases, the FDA expressed reservations about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, Addyi is the only FDA-approved oral medication for HSDD, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in 2019.

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

Additional specialists in female health voiced approval for the decision.

“There was nothing for me to recommend because everything was for women who were menstrual and not postmenopausal,” said an OB-GYN. “Securing the FDA approval for this patient population could be very important to help postmenopausal women who want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “understandable” given the clinical evidence.

Although supportive, the expert was cautious in her assessment: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the enhancement is not overwhelming. Is it worthwhile taking a drug daily and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Flibanserin, which is often called “female Viagra,” has few similarities with the drug from which it gets its informal name.

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

However, scientists noted improvements in aspects of sexual function and redirected efforts to the drug’s potential as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following additional research and a considerable advocacy campaign.

The medication carries a serious safety warning for serious adverse reactions, including low blood pressure (hypotension) and loss of consciousness, when combined with alcohol.

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

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

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

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

“Patients have experienced side effects like the syncopal episodes and dizziness especially in individuals who have had an drink within two hours of taking the pill. When you get more advanced in age, you become more sensitive to things like that,” she said.

Another doctor echoed uncertainty about why the expanded indication was limited at 65 years of age.

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

Addressing Low Libido After Menopause

Notwithstanding the warnings, Addyi could still broaden treatment options for low desire to a different group of women who may benefit.

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

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

So addressing low desire means engaging with everything from partnership issues to shifts in hormone levels.

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

• hot flashes
• vaginal dryness
• pain during intercourse
• insomnia
• urinary incontinence

As noted by one expert, treating these issues is often a initial approach toward improved intimacy.

“When a patient presents with concerns about desire, my initial inquiry is: How’s your vagina feeling? Are you comfortable?” she said.

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

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

Androgen therapy is also occasionally used without formal approval to treat reduced desire in females, although it is not indicated for it.

But besides medication, experts say that lifestyle should also be considered. Discussions about libido almost always begin by focusing on 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 psychosocial issues going on,” she said.

Additional recommendations for increasing sexual desire are:

• getting more sleep
• engaging in physical activity
• staying active
• applying over-the-counter personal lubricants
• practicing extended intimate stimulation
• incorporating vibrators or dilators

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