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The federal agency broadened the authorized use of a once-a-day medication to address low libido in women to include women after menopause up to age 65.

Prior to the announcement, the drug, flibanserin (Addyi), was only approved to address hypoactive sexual desire disorder (HSDD) in premenopausal females.

This medication was originally authorized by the FDA in 2015, following a protracted and controversial regulatory scrutiny.

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

Today, Addyi is the exclusive pill authorized for HSDD, though the FDA cleared bremelanotide (Vyleesi), an on-demand injection, in two thousand nineteen.

The founder and CEO of the pharmaceutical company of Addyi praised the FDA’s move 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 regulatory move.

“Previously, options were limited for me to prescribe because everything was for women who were menstrual and not menopausal,” said an obstetrician-gynecologist. “Getting the FDA clearance for this patient population could be significant to address women after menopause 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 existing research.

Although supportive, the expert was guarded in her evaluation: “The studies showed statistical significance of the drug over the inactive pill, but the magnitude of the improvement is not dramatic. Is it worthwhile taking a drug every single day and not getting bang for your buck?”

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

Addyi, which is sometimes referred to as “female Viagra,” has significant differences with the medication from which it draws its nickname.

This medication was initially researched as an medication for depression but was found to be lacking during initial trials.

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

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

Addyi carries a serious safety warning for severe adverse reactions, including a drop in blood pressure and fainting (syncope), when combined with alcohol.

The label recommends allowing a two-hour gap after consuming alcohol before using Addyi to minimize the chance of syncope. If a person has three or more alcoholic drinks on a given day, the instructions recommends skipping the dose entirely.

Claims about the interactions of combining Addyi and alcohol eventually led the maker to fund additional studies investigating the interaction. The research, which were small in scale, demonstrated no increased danger of syncope. But experts had reservations.

“This research aren't very convincing to me. They are a beginning, but they’re not very large-scale and certainly are short-term,” a health research president stated.

An gynecologist speculated that this may have been part of the cause why Addyi was not originally approved for older females.

“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 more advanced in age, you become more susceptible to things like that,” she said.

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

“It's unclear 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 cleared, they need to come out with an simpler guidance because it may affect our clinical decisions,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

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

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

But it is not a simple solution. In fact, the specialists interviewed all agreed that the female libido is influenced by many factors.

So treating low desire means considering everything from partnership issues to shifts in hormone levels.

Women after menopause experience a broad range of symptoms that can affect sexual desire. Symptoms of menopause include:

• sudden feelings of heat
• lack of natural lubrication
• pain during intercourse
• sleep disturbances
• urinary incontinence

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

“If somebody came to me with concerns about desire, 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 alleviate the symptoms of menopause, particularly dryness.

She expressed hope that the regulatory decision to lift of its “serious” warning on HRT will lead more women to feel less apprehensive 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 officially approved for it.

But besides medication, doctors say that lifestyle should also be considered. Conversations about sexual desire almost always begin by focusing on partnership dynamics and closeness.

“I would have no problem prescribing flibanserin after having a conversation with a patient. But I would also encourage them to talk about some of the emotional and relational factors going on,” she said.

Other recommendations for increasing libido are:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter lubricants
• engaging in extended foreplay
• incorporating vibrators or vaginal 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 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.”