Flibanserin (Addyi), the drug manufactured by Sprout Pharmaceuticals for the treatment of hypoactive sexual desire disorder (HSDD), received approval from the FDA for use in postmenopausal women up to age 64 last week.

The medication was first approved a decade ago for premenopausal women, but no FDA-approved pharmacologic options have been available to postmenopausal women until now.

“This milestone reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized,” Cindy Eckert, founder and CEO of Sprout Pharmaceuticals, said in a prepared statement. “This is a major shift in expanding awareness and access to treatment for HSDD — a condition that is both common and profoundly undertreated — and we’re grateful that the FDA has acknowledged the importance of closing this gap in women’s sexual healthcare.”

Pebble Kranz, MD, medical director of the Rochester Center for Sexual Wellness, told Medscape Medical News that the expansion of Addyi’s indication was a “sensible and overdue step.”

“It’s always a positive development when more options become available for patients,” Kranz said. “The original restriction to premenopausal women never made much physiological sense — this is a central nervous system medication, similar in mechanism to some mood-modulating drugs that we prescribe across age groups. We don’t separate pre- and postmenopausal populations for those, so it’s logical that we wouldn’t for this class either.”

HSDD, which refers to a persistent or recurring loss of desire for sexual activity that contributes to personal or interpersonal distress, is estimated to affect 1 in 10 US women. Key criteria for the condition include a noticeable decline from a previously satisfying level of desire that results in personal distress — not just a partner’s distress — and a desire to see improvement, “what we call ‘wanting to want,’” Kranz explained.

“It’s also essential that potentially treatable contributing factors are identified and addressed,” she added, directing providers to the International Society for the Study of Women’s Sexual Health process of care for an evidence-based framework to use in evaluating and supporting patients with sexual desire concerns.

The expanded approval was not based on new evidence but rather on the existing studies conducted prior to flibanserin’s first approval — SNOWDROP and PLUMERIA — and changes in the FDA’s Priority Review program.

As Ob/Gyn Jen Gunter, MD, wrote in her newsletter The Vajenda, flibanserin’s effect on postmenopausal women is “slightly smaller than that seen in premenopausal women.” She cites a 2024 systematic review and meta-analysis in which postmenopausal women experienced 0.37 more satisfying sexual events per month than those taking a placebo, whereas premenopausal women experienced 0.69 more satisfying sexual events.

The bigger concern, Gunter notes, is the cost of the drug if it is not covered by insurance, which is estimated to be $1100 per month, or $300 per month with a GoodRx coupon.

“Flibanserin is a reasonable option for bothersome low sexual desire,” she added, but “whether the modest improvement (at best) over placebo is worth it, especially given the price, is a personal decision,” she wrote.

Kranz further cautioned that Addyi’s expanded approval does not necessarily mean that women should turn first to pharmacologic options when seeking treatment for a low libido.

“Sexual desire is complex — before turning to medication, it’s crucial to understand and address all the contributing factors: medication side effects, relational or emotional stressors, fatigue, pain, and other aspects of sexual function or mood that might be interfering,” Kranz said. “Once those are managed, and if a medical approach still makes sense and is desired, flibanserin and other medications become an option.”

The only other medication approved by the FDA for HSDD in women is bremelanotide (Vyleesi), approved in 2019, but also only for premenopausal women. While flibanserin is an oral pill taken daily, Vyleesi is a subcutaneous injection taken only as needed approximately 45 minutes before anticipated sexual activity.

The main side effect of Addyi to be concerned about is sedation, Kranz said, particularly for older adults. “Flibanserin should be taken at bedtime for this reason, and it should be used cautiously with other sedating medications or alcohol,” Kranz said.

When flibanserin was first approved, contraindications included consumption of any alcohol while taking the medication to avoid risk of hypotension or syncope. Since then, however, the recommendation has been slightly relaxed to advise waiting at least 2 hours after drinking one to two standard drinks before taking a flibanserin dose and skipping a dose if a person consumes three or more standard alcoholic drinks. Other contraindications include existing liver problems and taking certain medications for HIV, fungal infections, and hepatitis; nefazodone; and some antihypertensives and antibiotics.

Kranz reported having no industry disclosures.

Tara Haelle is a science and health journalist based in Dallas.