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The federal agency widened the indication of a once-a-day medication to treat hypoactive sexual desire disorder (HSDD) in females to cover women after menopause up to 65 years old.

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

This medication was initially cleared by the FDA in two thousand fifteen, following a protracted and controversial evaluation period.

The agency had denied approval for the drug on two separate occasions, in 2010 and 2013. In each instance, the agency raised concerns about safety, efficacy, and an unfavorable risk–benefit profile.

Currently, Addyi is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA approved Vyleesi (bremelanotide), an on-demand injection, in 2019.

The founder and CEO of the maker of flibanserin commended the FDA’s action to expand the drug’s indication, calling it a “milestone” in advancing and focusing on women's sexual wellness.

Other specialists in female health were supportive for the decision.

“Previously, options were limited for me to prescribe because everything 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 want to have sexual activity and enjoy sex, but sometimes have problems regarding libido.”

A professor of obstetrics and gynecology told reporters that the approval was “quite reasonable” given the existing research.

While in favor, the expert was measured in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not overwhelming. Is it worthwhile taking a drug daily and not getting bang for your buck?”

Understanding Flibanserin, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “female Viagra,” has little in common with the medication from which it gets its informal name.

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

However, researchers observed improvements in measures of libido and arousal and redirected efforts to the drug’s possible use as a treatment for low libido.

Following initial denials, flibanserin was approved in 2015 to treat HSDD, following additional research and a major advocacy campaign.

Addyi carries a boxed (“black box”) warning for severe adverse reactions, including a drop in blood pressure and loss of consciousness, when taken alongside alcoholic drinks.

Official guidance advises allowing a two-hour gap after drinking before taking Addyi to minimize the risk of syncope. If a person consumes three or more alcoholic drinks on a single occasion, the label recommends not taking the pill entirely.

Assertions about the interactions of combining the drug with drinking eventually led the pharmaceutical company to fund further research investigating the interaction. The research, which were small in scale, demonstrated no increased danger of fainting. But experts had reservations.

“This research don’t seem very persuasive to me. They are a good start, but they’re not very big and certainly aren’t very long,” a health research president stated.

An OB-GYN suggested that this may have been part of the cause why Addyi was not originally approved for postmenopausal women.

“Patients have experienced adverse reactions like the fainting spells and dizziness especially in persons who have had an alcoholic beverage within two hours of treatment. When you get more advanced in age, you become more susceptible to things like that,” she said.

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

“It's unclear 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 simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire After Menopause

Notwithstanding the warnings, flibanserin could still expand therapeutic choices for HSDD to a different group of women 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 magic bullet. In fact, the experts consulted all agreed that the female libido is complex and multifaceted.

So addressing HSDD means engaging with everything from partnership issues to hormonal changes.

Women after menopause navigate a broad range of changes that can impact libido. Symptoms of menopause include:

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

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

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

The expert recommended both vaginal estrogen and systemic hormone therapy as options to alleviate the symptoms of menopause, particularly vaginal dryness.

She expressed hope that the regulatory decision to lift of its “black box” warning on hormone therapy will lead more women to feel less concerned about it and to consider it as a treatment option.

Testosterone is also sometimes prescribed off-label to treat low libido in females, although it is not indicated for it.

But in addition to drugs, experts say that personal habits should also be factored in. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I would have no problem recommending Addyi after discussing it with a patient. But I would also advise them to talk about some of the psychosocial issues going on,” she said.

Additional suggestions for boosting libido include:

• improving sleep hygiene
• engaging in physical activity
• maintaining an active lifestyle
• using over-the-counter lubricants
• practicing extended foreplay
• using vibrators or vaginal dilators

“You have to take an entire whole body approach to sexual health and this life stage in older age,” said an OB-GYN. “That means understanding how your body works, your anatomy, 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.”