Addyi for postmenopausal women: what the December 2025 FDA approval means

2025-12-15

On 15 December 2025, the US FDA extended approval of Addyi (flibanserin) to postmenopausal women under 65 with distressing low sexual desire. In the trial behind the change its benefit over placebo was small, and it still carries a boxed warning about alcohol.

Researched by the MenoWoman team. Edited by Marcela Sat. Updated 7 November 2026. We may earn from links.

See a doctor if low desire is new or distressing, or comes with pain during sex, low mood, or a change in health or medicines. If you take Addyi, get urgent help for fainting or severe dizziness, especially after alcohol, and check with a pharmacist before starting any new medicine.

What the FDA approved

Addyi is a non-hormonal daily pill made by Sprout Pharmaceuticals. It was first approved in the US in 2015 for premenopausal women.^3,4 It acts on brain chemicals linked to mood and desire.³

The label revised in December 2025 covers women under 65 with acquired, generalized hypoactive sexual desire disorder (HSDD).¹ That means low desire that developed after a time of normal desire, happens in all situations, and causes marked distress or relationship difficulty.¹

The low desire must not be better explained by another medical or mental health condition, relationship problems, or a medicine.¹ Addyi is not for men and is not meant to improve sexual performance.¹ It is taken at bedtime.¹

This is a US approval. Licensing and availability in other countries differ, so ask a local doctor or pharmacist.

How well it works after menopause

Low desire is common in midlife. Low desire is reported by roughly 40–55% of women going through menopause.⁸ HSDD also requires distress, and estimates of how many postmenopausal women have it vary widely between studies, from about 9% to about one in three.^3,8

The new approval rests on one 24-week trial in postmenopausal women, called Study 6 in the label. It randomly assigned 447 women to Addyi and 455 to placebo.¹

Women on Addyi improved slightly more than women on placebo. The extra gain in satisfying sexual events was small, under half an event, and the statistical range reached zero.¹ Scores for desire and for distress about low desire also improved a little more than with placebo.¹

A second postmenopausal trial was stopped early.¹ The FDA turned Addyi down twice before its 2015 approval, citing modest effectiveness and side effects.⁴

Common side effects included dizziness, sleepiness, nausea, tiredness, insomnia and dry mouth.^1,2 In the postmenopausal trial, 9% of women on Addyi stopped because of side effects, compared with 5% on placebo. In premenopausal trials the figures were 13% and 6%.¹

Addyi and alcohol: the warning as it stands

Addyi carries a boxed warning, the strongest kind of FDA warning. Alcohol taken close in time to a dose raises the risk of severe low blood pressure and fainting.¹

Until 2019 the label said women taking Addyi had to avoid alcohol completely. In April 2019 the FDA changed this to a warning about timing.⁵ Trials had shown a lower risk when women waited after a small amount of alcohol before the bedtime dose.⁵

The current label sets out how long to wait after drinking and when to skip a dose. It also says to avoid alcohol after a dose until the next day.¹ Your prescriber or pharmacist should go through these rules with you.

The boxed warning also covers certain medicines that block a liver enzyme called CYP3A4. These must not be combined with Addyi. It is also not used in anyone with liver impairment.¹ Tell your doctor and pharmacist about every medicine and supplement you take.

Addyi vs testosterone and other options

Low desire often has several causes, including medical conditions, depression and relationship problems. Doctors need to rule these out before prescribing.⁴ Some psychologists question whether low desire should be treated as a medical disorder at all.⁴

Testosterone. An international consensus statement says HSDD in postmenopausal women is the only evidence-based use of testosterone in women.⁶ At doses matching normal female levels, it gave about one extra satisfying sexual event a month over placebo.⁶ When the statement was published, no regulator had approved a testosterone product for women, and doctors in some countries adapted other products off-label.⁶ Since then, a testosterone cream for women has been licensed in Australia, New Zealand and South Africa.⁷ See testosterone for women.

Vaginal estrogen and lubricants. If dryness or pain makes sex uncomfortable, treating that may help. See vaginal estrogen and moisturizers and lubricants.

Non-drug steps. Doctors interviewed about the approval suggested better communication with a partner and making time for intimacy.³

What it means for you

For some women with distressing low desire, Addyi is now an approved option to discuss with a US prescriber. Expected gains are small, and the side effects and alcohol rules matter.^1,2

US doctors expect the approval may make insurance coverage easier, since prescribing to postmenopausal women was previously off-label.³

Our low libido page covers all the options, and our alcohol and menopause page covers drinking more broadly.

Addyi for postmenopausal women: what the December 2025 FDA approval means

What the FDA approved

How well it works after menopause

Addyi and alcohol: the warning as it stands

Addyi vs testosterone and other options

What it means for you

Related

Sources