What Is Addyi, and Why Does It Matter?
Addyi (flibanserin) is a nonhormonal prescription pill that is now approved by the FDA to treat low sexual desire in women younger than 65, including those who are postmenopausal. It’s used for a condition called hypoactive sexual desire disorder (HSDD), meaning you have little or no interest in sex, which causes you distress and is not explained by other medical conditions, mental health issues, or relationship problems.
Addyi is thought to work by affecting certain brain chemicals — like serotonin and dopamine — that help regulate sexual interest, though its precise mechanism of action is yet to be known.
HSDD is the most common form of sexual dysfunction in women, affecting about 40% of all women. This is the first time the FDA has approved an oral treatment for low sexual desire in postmenopausal women. Previously approved in 2015, Addyi was used only in premenopausal women. This expanded approval gives more women access to a treatment option for a condition that often goes unrecognized and untreated. However, Addyi is not meant to improve sexual performance and is not approved for use in men or children.
Why Was It Approved?
The FDA has approved Addyi for postmenopausal women based on clinical studies that showed it helped improve sexual desire and reduced distress related to low interest in sex.
In a 24-week clinical trial of postmenopausal women younger than 65 taking Addyi (100 milligrams at bedtime) or a placebo, Addyi modestly improved sexual desire and satisfaction compared with placebo. Women who took Addyi versus those who took the placebo reported an average increase of 1.0 versus 0.6 satisfying sexual events per month, and their sexual desire scores improved by 0.7 points vs 0.4 points. Distress related to low desire decreased more in women on Addyi than in those on the placebo. Overall, the treatment showed statistically significant benefits for sexual desire, satisfaction, and related distress.
The most common side effects include dizziness, sleepiness, nausea, tiredness, dry mouth, and trouble sleeping. More serious risks include low blood pressure and fainting, especially if you take Addyi with alcohol, during the day, or with certain other medicines. Because of these risks, Addyi comes with a boxed warning, which is the FDA’s strongest safety alert.
What Do I Need to Know?
Addyi is taken as a 100-milligram tablet once a day at bedtime. It’s important to take it only at night because using it during the day can increase your risk for low blood pressure, fainting, and extreme sleepiness.
Drinking alcohol while using Addyi can worsen these side effects. If you’ve had one or two drinks, wait at least two hours before taking your dose. Skip your dose on the night that you’ve had three or more drinks. Don’t drink alcohol again until the next day.
You should not take Addyi if you have liver problems or if you’re using certain medicines, including some antibiotics, antifungals, or medicines for HIV, hepatitis C, or heart conditions. Addyi also shouldn’t be used with medicines that strongly affect how your body processes medicines called CYP3A4 inhibitors. Be sure to tell your health care provider about all the medicines, including over-the-counter products, vitamins, supplements, and herbal remedies, you take to avoid any harmful interaction. Avoid grapefruit juice and herbal products like St John’s wort, ginkgo, and resveratrol as they can increase your risk for side effects.
Don’t drive or use heavy machinery for at least six hours after taking Addyi because it may cause sleepiness or dizziness. Addyi is not recommended if you’re breastfeeding, and it’s not clear if it’s safe during pregnancy. Talk to your health care provider if you’re pregnant or planning to become pregnant or breastfeed to decide what’s best for you.