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The Food and Drug Administration (FDA) widened the indication of a daily pill to treat hypoactive sexual desire disorder (HSDD) in females to cover postmenopausal women up to the age of sixty-five.

Before the recent news, the pill, flibanserin (Addyi), was solely authorized to treat low sexual desire in premenopausal females.

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

The FDA previously rejected the drug on two distinct instances, in 2010 and 2013. In both cases, the agency cited issues about its safety profile, effectiveness, and an unfavorable risk–benefit profile.

Now, Addyi is the sole oral drug cleared by the FDA for hypoactive sexual desire disorder, though the FDA cleared Vyleesi (bremelanotide), an injectable used when desired, in 2019.

The chief executive of the pharmaceutical company of Addyi applauded the FDA’s action to expand the drug’s indication, calling it a “milestone” in understanding and prioritizing female sexual health.

Additional women’s health experts voiced approval for the regulatory move.

“I had few tools for me to prescribe because available treatments was for women who were premenopausal and not menopausal,” said an OB-GYN. “Securing the FDA clearance for this patient population could be crucial to help women after menopause who want to have sexual activity and experience pleasure, but sometimes have problems regarding libido.”

A clinical professor told reporters that the approval was “quite reasonable” given the existing research.

Although supportive, the expert was guarded in her assessment: “The studies showed statistical significance of the drug over the placebo, but the degree of the enhancement is not overwhelming. Does it justify taking a drug every single day and not seeing a major effect?”

What is Addyi, the ‘Female Viagra’?

Addyi, which is sometimes referred to as “the women's version of 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 considered unsuccessful during early studies.

Nevertheless, researchers observed positive changes in measures of sexual function and shifted focus to the drug’s possible use as a treatment for diminished sexual desire.

Following initial denials, flibanserin was cleared in 2015 to treat HSDD, following further studies and a considerable lobbying effort.

Addyi carries a boxed (“black box”) warning for severe side effects, including a drop in blood pressure and loss of consciousness, when combined with alcohol.

The label advises waiting at least two hours after drinking before taking Addyi to reduce the chance of syncope. If a person has several drinks on a given day, the instructions recommends skipping the dose entirely.

Assertions about the effects of combining the drug with drinking eventually prompted the pharmaceutical company to fund additional studies investigating the interaction. The studies, which were small in scale, demonstrated no additional risk of syncope. But experts had reservations.

“These studies aren't very persuasive to me. They are a beginning, but they’re not very big and certainly aren’t very long,” a public health expert stated.

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

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

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

“It's unclear if that has to do with the complexity of the drug. 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 simpler guidance because it may affect our prescribing,” he said.

Treating Diminished Sexual Desire in Postmenopausal Women

Despite these risks, flibanserin could still broaden therapeutic choices for HSDD to a new population of women who may find help.

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

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

So treating low desire means considering everything from relationship dynamics to shifts in hormone levels.

Postmenopausal females navigate a broad range of symptoms that can affect sexual desire. Menopausal symptoms encompass:

• hot flashes
• vaginal dryness
• pain during intercourse
• sleep disturbances
• bladder leakage

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

“If somebody came to me with libido issues, my first question is: How’s your vagina feeling? Are you comfortable?” she said.

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

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

Androgen therapy is also sometimes prescribed off-label to address reduced desire in women, although it is not indicated for it.

But in addition to drugs, doctors say that lifestyle should also be considered. Discussions about sexual desire almost always begin by focusing on relationships and intimacy.

“I am comfortable recommending Addyi after having a conversation with a patient. But I would also encourage them to talk about some of the psychosocial issues going on,” she said.

Other suggestions for boosting sexual desire include:

• improving sleep hygiene
• exercising
• staying active
• using over-the-counter personal lubricants
• engaging in extended intimate stimulation
• incorporating vibrators or dilators

“You have to take an comprehensive, holistic strategy to sexuality and this life stage in older age,” 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 excited, and ultimately to have a peak of sexual pleasure.”