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FDA approved Addyi (flibanserin) for the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women under the age of 65.

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The medicine is to be taken daily to treat premenopausal women suffering from hypoactive sexual desire disorder, which is essentially a sudden, unexplained loss of any desire to have sex. "Addyi is a game changer, in my opinion, for women's health," said Cynthia Whitehead, Sprout's CEO. "For decades, millions of women have been waiting for a medical solution to restore their sexual desire. And I'm thrilled that today the decision is finally being turned over to women and their health care providers regarding their sexual health." The pill has long history of controversy. The company and its supporters had essentially accused the FDA of being sexist for rejecting the drug twice before while approving Viagra and other drugs to help men with their sexual problems.

Sex education and counseling

"For far too long we've reduced all things in the bedroom for men to biology, as witnessed by countless treatment options, and we've reduced all things for women to psychology," Whitehead says. In June, Sprout finally convinced an FDA advisory committee to recommend the drug's approval by providing new studies to show it can safely boost a woman's sex drive, enabling them to have more satisfying sexual experiences. The decision was welcomed by some doctors and women's advocates, who said they hoped it would open to the door to more drugs to help women with sexual problems. "Clearly we need more than just one medication — women need to have an array of choices that meets their specific medical needs," says Terry O'Neill sex with tablet of the National Organization for Women. "So with this success I think there will be more development of more medications. Addyi was previously approved in 2015 for the treatment of HSDD in premenopausal women.

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• [Homeopathic Libido Pills: Highly diluted substances.]
• [Libigirl: Herbal supplement blend for women.]
• [VigorUp for Women: Contains tribulus and other herbs.]
• [HerSolution: Herbal supplement marketed for arousal.]

Past research shows that between 40-55% of people advancing through menopause experience low sexual desire, and about 9% of postmenopausal women have HSDD.

On December 15, 2025, the U.S.

• Aphrodisiac pills for heightened pleasure.
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Food and Drug Administration (FDA) approved the medication Addyi was previously approved in 2015 for the treatment of HSDD in premenopausal women. Premenopause or “before” menopause refers to the reproductive time in a cisgender woman’s life when they have regular menstrual cycles. Postmenopause refers to the time period after the person finishes menopause and no longer has a menstrual cycle. The majority of people start menopause between the While people can experience HSDD at any age, it is not uncommon to experience a low libido during menopause and postmenopause. Past research shows that between 40-55% of women advancing through menopause experience low sexual desire, and about 9% of postmenopausal women have HSDD.

Medical Treatments for Low Libido

As part of the approval, Sprout has also agreed to conduct additional safety studies. The cenforce 150 uk company hopes many insurance companies will cover the new drug to the same level they cover drugs like Viagra. If so, Whitehead estimated it would cost women between $30 and $75 a month in out-of-pocket costs. The company is also planning to offset the expenses for women who don't have insurance so it doesn't cost them more than that, she said. On December 15, 2025, the U.S. With the expanded approval to postmenopausal women under 65, Medical News Today spoke with three women’s health experts to find out more about how Addyi works, its side effects, what does this approval mean for menopausal women, and any non-medication alternatives they suggest for low libido. Addyi is a prescription medication manufactured by Sprout Pharmaceuticals.

“Addyi is a non hormonal medication that works on neurotransmitters in the brain to help regulate mood and increase sex drive,” Susan Marie Pacana, MD, minimally invasive gynecologic surgeon and OB/GYN at Hackensack Meridian Jersey Shore University Medical Center in New Jersey, told MNT. “Addyi is a medication for women that, according to the manufacturer, increases sexual desire,” Prudence Hall, MD, an OB/GYN in private practice in Santa Monica, CA, and author of Radiant Again & Forever: Overcome Menopause & Restore Your Radiance, added. “After taking it for a month, dopamine and serotonin levels are apparently enhanced, which supposedly increases sexual desire.” With the expanded approval for postmenopausal women under the age of 65, G. Thomas Ruiz, MD, a board certified OB/GYN at MemorialCare Orange Coast Medical Center in Fountain Valley, CA, told MNT that Addyi could now help a greater number of women. “The group of women where I get the biggest complaints of decreased libido is in the 50 to 60 year old age bracket, so potentially this could be a very important medication for them,” Ruiz added.

When to Consider Professional Help for Low Libido

They say Addyi is just another example of the pharmaceutical industry making what is normal human behavior for some people something people need to take a pill to fix. Some women naturally lose interest in sex, they say, or may lose interest in sex for other reasons, such as being in a bad relationship. "This decision to approve flibanserin is a triumph of marketing over science," Pearson says. The FDA is requiring the company and doctors to warn women not to drink alcohol while taking Addyi, to cut the risk they'll faint or wake up woozy. Women should also avoid taking Addyi with certain other drugs, including some medications used to treat yeast infections. Pacana, who is also a Menopause Society Certified Practitioner, commented that the lack of medications for low libido has been a long-standing issue, but the new FDA approval for this treatment up to age 65 is a major step forward.

Alternative medicine

Sildenafil treatment of women with antidepressant-associated sexual dysfunction: a randomized controlled trial. 13.Basson R, McInnes R, Smith MD, Hodgson G, Koppiker N. Efficacy and safety of sildenafil citrate in women with sexual dysfunction associated with female sexual arousal disorder. 14.Schoen C, Bachmann G. Sildenafil citrate for female sexual arousal disorder: a future possibility?

‘Scheduling’ sex may help

The influence of testosterone combined with a PDE5-inhibitor on cognitive, affective, and physiological sexual functioning in women suffering from sexual dysfunction. The Food and Drug Administration approved the first drug designed to increase a woman's libido. The controversial decision was hailed by some doctors and advocates as a long-sought victory for women's health, but was condemned by others as irresponsible and dangerous. The little pink pill, known generically as flibanserin, will be sold under the brand name Addyi beginning Oct. 17, according to its maker, Sprout Pharmaceuticals. “Women of all ages present to our office with complaints of low sex drive that affect their relationships, self-esteem, and body image,” she explained.

• [Cialis (Tadalafil): Off-label use for female sexual arousal.]
• [Levitra (Vardenafil): Another PDE5 inhibitor used off-label.]
• [Stendra (Avanafil): PDE5 inhibitor, potential off-label use.]
• [Muse (Alprostadil): Urethral suppository, primarily for men.]
• [Caverject (Alprostadil): Injection, primarily for men.]

“It often is accompanied by feelings of shame, frustration and guilt when women are unable to meet their partner’s sexual expectations.” “Previously, I could prescribe it off-label for postmenopausal women, but they were unfairly denied insurance coverage.

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Diagnostic and Statistical Manual of Mental Health Disorders, Fourth Edition, Text Revision. Biological and psychosocial pathophysiology of female sexual dysfunction during the menopausal transition. Revised definitions of women’s sexual dysfunction. The neurovascular mechanism of clitoral erection: nitric oxide and cGMP-stimulated activation of BKCa channels. 8.Licht MR.

More Information

Sildenafil (Viagra) for treating male erectile dysfunction. 9.Berman JR, Berman LA, Toler SM, Gill J, Haughie S, Sildenafil Study Group Safety and efficacy of sildenafil citrate for the treatment of female sexual arousal disorder: a double-blind, placebo controlled study. 10.Caruso S, Rugolo S, Agnello C, Intelisano G, Di Mari L, Cianci A. Sildenafil improves sexual functioning in premenopausal women with type 1 diabetes who are affected by sexual arousal disorder: a double-blind, crossover, placebo-controlled pilot study. 12.Nurnberg HG, Hensley PL, Heiman JR, Croft HA, Debattista C, Paine S. Now, with this official approval, we can finally expect insurers to cover this necessary treatment for a wider population of women.” Like all medications, Addyi has known potential side effects, including: However, Addyi also carries a “black box” warning from the FDA as when taken with alcohol or certain medications, Addyi can cause low blood pressure (severe hypotension) or a risk of fainting (syncope). Ruiz said it would be very helpful for the drug company to issue a simple handout of all the “do’s and don’ts” associated with Addyi.

• [Pregnenolone: Hormone precursor, potential role in desire.]
• [Dopamine Agonists: Like pramipexole, investigational for desire.]
• [Oxytocin Nasal Spray: Hormone for bonding, under research.]
• [Cannabis/CBD: Some report increased sensation, legality varies.]
• [Kava Kava: For anxiety, may reduce sexual inhibition.]

“They’ve got to make it as least confusing for patients to use as possible, so a simple do’s and don’ts information sheet would be useful,” he detailed.

The #1 Prescribed Treatment for frustrating Low Libido1

And that is all to the good." But the FDA's approval was being denounced by critics. They say Addyi doesn't work very well, if at all, and can cause troubling side effects. According to the documents released in conjunction with the advisory panel's June meeting, three studies that compared Addyi with a placebo found that women using the drug had a median of 0.5 or 1.0 more satisfying sexual events a month, depending on the study. The median number of satisfactory sexual experiences each month before the drug test was two or three. Some women faint when they take it.

Medications for HSDD

Others wake up so groggy the morning after it could be dangerous for them to drive to work. And there could be long-term risks from taking a psychoactive drug daily for years. Addyi works by altering the levels of three important neurotransmitters — norepinephrine, serotonin and dopamine. "To have any chance of benefit from this drug they're going to have to take it every day for months on end, years," says Cindy Pearson of the National Women's Health Network. "We just don't know what the long-term effects will be of changing brain chemistry in this way." In addition, some say the campaign to win approval for the drug has oversimplified human sexuality. “And that would be useful for providers.” For women who may not want to take medication, what other things can they do to help with a low libido?