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U.S. regulators 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 age 65.

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

The drug was initially cleared by the FDA in 2015, following a lengthy and contentious review process.

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the agency expressed reservations about its safety profile, effectiveness, and an concerning balance of risks and benefits.

Today, flibanserin is the exclusive pill authorized for hypoactive sexual desire disorder, though the FDA cleared bremelanotide (Vyleesi), an as-needed injectable treatment, in two thousand nineteen.

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

Additional specialists in female health expressed support for the regulatory move.

“There was nothing for me to prescribe because available treatments was for women who were premenopausal and not postmenopausal,” said an obstetrician-gynecologist. “Getting the FDA approval for this group of women could be crucial to help women after menopause who want to have sexual activity and enjoy sex, but sometimes have issues with libido.”

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

While in favor, the expert was measured in her evaluation: “Clinical trials 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 experiencing a dramatic change?”

What is Flibanserin, the ‘Female Viagra’?

Flibanserin, which is sometimes referred to as “the women's version of Viagra,” has few similarities with the medication from which it draws its nickname.

The drug was originally developed as an antidepressant but was found to be lacking during initial trials.

However, scientists noted positive changes in aspects of sexual function and shifted focus to the drug’s possible use as a therapy for diminished sexual desire.

After two rejections, Addyi was cleared in 2015 to treat hypoactive sexual desire disorder, 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 fainting (syncope), when combined with alcoholic drinks.

Official guidance advises waiting at least two hours after consuming alcohol before using Addyi to reduce the chance of syncope. If a person has several drinks on a single occasion, the instructions recommends skipping the dose entirely.

Assertions about the effects of combining Addyi and alcohol eventually prompted the maker to fund additional studies investigating the combination. The research, which were small in scale, showed no increased danger of fainting. But medical professionals had reservations.

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

An gynecologist speculated that this may have been part of the reason why Addyi was not initially cleared for older females.

“Patients have experienced adverse reactions like the fainting spells and lightheadedness 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 sensitive to things like that,” she said.

Another doctor echoed 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. Reviewing 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 prescribing,” he said.

Addressing Diminished Sexual Desire After Menopause

Despite these risks, Addyi could still broaden therapeutic choices for HSDD to a different group of women who may benefit.

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

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

So treating low desire means engaging with everything from partnership issues to hormonal changes.

Postmenopausal females experience a broad range of changes that can affect libido. Symptoms of menopause include:

• hot flashes
• vaginal dryness
• discomfort with sex
• sleep disturbances
• urinary incontinence

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

“When a patient presents with libido issues, my initial inquiry is: How’s your vagina feeling? 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 vaginal dryness.

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

Androgen therapy is also occasionally used without formal approval to address low libido in females, although it is not officially approved for it.

But in addition to drugs, doctors say that lifestyle should also be factored in. Discussions 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 encourage them to talk about some of the emotional and relational factors going on,” she said.

Other suggestions for increasing libido are:

• getting more sleep
• exercising
• maintaining an active lifestyle
• using over-the-counter personal lubricants
• engaging in extended foreplay
• using vibrators or dilators

“It requires an entire whole body approach to sexuality and this life stage in later life,” said an expert. “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 aroused, and ultimately to have a climax of orgasm.”