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The federal agency broadened the authorized use of a daily pill to manage hypoactive sexual desire disorder (HSDD) in women to now encompass women after menopause up to 65 years old.

Prior to the announcement, the medication, flibanserin (Addyi), was exclusively cleared to address hypoactive sexual desire disorder (HSDD) in women of reproductive age.

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

The agency had denied approval for the drug on two separate occasions, in 2010 and again in 2013. In each instance, the agency cited issues about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Currently, 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 pharmaceutical company of flibanserin praised the FDA’s decision to expand the drug’s approval, calling it a “significant step” in advancing and focusing on female sexual health.

Additional women’s health experts expressed support for the regulatory move.

“There was nothing for me to recommend because available treatments was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this group of women could be very important to address women after menopause who want to have sexual activity and experience pleasure, but sometimes have issues with libido.”

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

Although supportive, the expert was guarded in her assessment: “Clinical trials showed statistical significance of the drug over the inactive pill, but the degree of the improvement is not overwhelming. Does it justify taking a drug every single day and not experiencing a dramatic change?”

Understanding Addyi, the ‘Women's Desire Pill’?

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

This medication was first created as an medication for depression but was found to be lacking during early studies.

Nevertheless, researchers observed improvements in aspects of sexual function and redirected efforts to the drug’s possible use as a therapy for diminished sexual desire.

After two rejections, flibanserin was cleared in 2015 to treat HSDD, following further studies and a significant lobbying effort.

Addyi carries a boxed (“black box”) warning for serious adverse reactions, including low blood pressure (hypotension) and fainting (syncope), when taken alongside alcoholic drinks.

The label advises allowing a two-hour gap after drinking before taking Addyi to reduce the risk of fainting. If a person has several drinks on a given day, the label recommends not taking the pill entirely.

Claims about the effects of mixing the drug with drinking eventually led the pharmaceutical company to fund further research examining the interaction. The studies, which were limited in size, demonstrated no increased danger of fainting. But medical professionals had reservations.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very big and certainly are short-term,” a health research president stated.

An OB-GYN suggested that this may have been part of the cause why Addyi was not initially cleared for older females.

“There have been adverse reactions 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 effects like that,” she said.

Another doctor echoed uncertainty about why the broader approval was limited at 65 years of age.

“I don’t know if that has to do with the intricacies of the drug. 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 clearer instructions because it may affect our clinical decisions,” he said.

Addressing Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden treatment options for low desire to a new population of women who may find help.

“I do think it will serve this demographic better as long as they have no other medical problems,” said an specialist.

But it is not a quick fix. In fact, the experts interviewed all agreed that the women's sexual desire is influenced by many factors.

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

Postmenopausal females navigate a wide variety of changes that can impact sexual desire. Menopausal symptoms include:

• hot flashes
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

According to one expert, managing these symptoms is often a initial approach toward improved intimacy.

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

The expert suggested both topical estrogen therapy and systemic hormone therapy as options to treat the symptoms of menopause, particularly dryness.

She hopes that the FDA’s recent removal of its “serious” warning on hormone therapy will lead more women to feel less apprehensive about it and to view it as a viable choice.

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

But besides medication, experts say that lifestyle should also be factored in. Conversations about libido almost always begin by focusing on partnership dynamics and closeness.

“I am comfortable prescribing 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 boosting sexual desire are:

• improving sleep hygiene
• exercising
• staying active
• applying over-the-counter lubricants
• engaging in extended foreplay
• using sexual wellness devices or dilators

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an OB-GYN. “This involves knowing how your body works, your physiology, and your sexual needs — in other words, what makes you feel good, what allows you to get excited, and ultimately to have a peak of orgasm.”