Postmenopause: FDA approves first libido drug

The FDA has expanded the approval of Addyi (flibanserin) to include the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women under the age of 65, as of December 15, 2025. Addyi was initially approved in 2015 for premenopausal women with HSDD.

Research indicates that a significant percentage, between 40% and 55%, of women going through menopause experience decreased sexual desire, with approximately 9% of postmenopausal women diagnosed with HSDD.

Medical News Today spoke with women's health experts to learn more about Addyi, its effects, and what the approval means for women experiencing menopause. They also discussed non-medication alternatives for low libido. Addyi is manufactured by Sprout Pharmaceuticals and requires a prescription.

According to Dr. Susan Marie Pacana, a minimally invasive gynecologic surgeon and OB/GYN at Hackensack Meridian Jersey Shore University Medical Center in New Jersey, Addyi is a non-hormonal medication that affects brain neurotransmitters to help regulate mood and increase sex drive. Dr. Prudence Hall, an OB/GYN in private practice in Santa Monica, CA, and author of "Radiant Again & Forever: Overcome Menopause & Restore Your Radiance," explains that Addyi is designed to increase sexual desire in women.

Dr. Hall notes that Addyi is believed to enhance dopamine and serotonin levels after about a month of use, which may increase sexual desire.

Dr. G. Thomas Ruiz, a board-certified OB/GYN at MemorialCare Orange Coast Medical Center in Fountain Valley, CA, believes that the expanded approval could benefit a large group of women, especially those in their 50s and 60s who frequently report decreased libido.

Dr. Pacana, a Menopause Society Certified Practitioner, emphasized the importance of this FDA approval, noting the previous lack of approved medications for low libido. She stated that women of all ages often seek help for low sex drive, which can negatively impact relationships, self-esteem, and body image, leading to feelings of shame, frustration, and guilt.

Dr. Pacana also highlighted that while she could previously prescribe Addyi off-label for postmenopausal women, insurance coverage was often denied. She anticipates that the official approval will lead to broader insurance coverage for this treatment.

Potential side effects of Addyi include constipation, dizziness, dry mouth, headache, nausea, sleepiness or insomnia, stomach or back pain, and tiredness.

It's important to note that Addyi carries an FDA "black box" warning due to the risk of severe hypotension or syncope when taken with alcohol or certain medications. Dr. Ruiz suggests that the drug company provide a clear handout outlining the "do's and don'ts" of using Addyi to minimize confusion for both patients and providers.

For women seeking non-medication options, Dr. Hall suggests optimizing declining or absent hormones through treatments like estradiol patches or compounded creams. She also mentioned that restoring testosterone to youthful levels can enhance orgasms. Optimizing thyroid and adrenal stress hormones can also increase energy and reduce depression, potentially restoring sexuality to youthful levels.

Dr. Ruiz suggests that low libido can sometimes be attributed to a lack of understanding of female sexual function and communication with partners. He recommends scheduling time for intimacy and prioritizing foreplay, which may take an extended period. He also emphasized the importance of a good relationship with one's partner. Furthermore, Dr. Ruiz encourages women to practice self-stimulation to better understand their bodies and communicate their needs to their partners, which can be beneficial for menopausal women as well.