The U.S. Food and Drug Administration recently expanded approval of Addyi, a daily pill for low sex drive, to postmenopausal women up to age 65. This change could reach millions more women but faces ongoing doubts about its effectiveness and challenges. Sprout Pharmaceuticals sees it as a step forward for women’s health.
Recent FDA Expansion
On December 15, 2025, the FDA widened Addyi’s approval from premenopausal women to include postmenopausal women up to age 65. The drug, known scientifically as flibanserin, treats hypoactive sexual desire disorder, or HSDD, a condition marked by low sexual interest that causes distress. Sprout Pharmaceuticals, the current maker, calls this a key advance in women’s sexual health after years of limited use.
This expansion builds on earlier approvals, such as Health Canada’s decision in 2021 for similar patients. The SNOWDROP trial supported the move, testing 949 stable, heterosexual postmenopausal women over 24 weeks. While results showed some benefit, experts stress that low desire often needs a full-body approach beyond just medication.
How the Drug Works
Addyi works in the brain by reducing serotonin while increasing dopamine and norepinephrine to boost sexual motivation. Unlike pills for men’s erectile issues that improve blood flow, Addyi targets desire directly. Patients take one 100 mg pill at bedtime every day.
Clinical trials show small improvements. The SNOWDROP study found women on Addyi had 0.69 more sexually satisfying events per month than those on placebo. A 2024 review of trials with 8,000 women reported just 0.37 extra events monthly, highlighting modest gains.
Rocky Path to Approval
Drug developer Boehringer Ingelheim sought FDA approval in 2010 and again before 2013 but faced rejection twice. Regulators cited weak results, risks like driving impairment, and dangerous interactions with alcohol. Approval finally came on August 18, 2015, after strong advocacy from women’s health groups.
The FDA required a special Risk Evaluation and Mitigation Strategy, or REMS, program. This mandates training for doctors who prescribe it. An advisory panel voted 18-6 in favor, but divisions lingered over benefits versus risks.
Sprout bought the drug rights and sold it to Valeant for $1 billion soon after. Valeant later sold it back at a big loss by 2017 as sales disappointed.
Persistent Challenges
Side effects remain a major issue. In trials, dizziness affected 11.4% of Addyi users compared to 2.2% on placebo, sleepiness hit 11.2% versus 2.9%, and nausea struck 10.4% versus 3.9%. About 13% of users quit due to side effects, twice the placebo rate. A strong warning label bans combining Addyi with alcohol due to risks of severe low blood pressure and fainting. Users must wait two hours after one or two drinks, skip the dose after three or more, and avoid it until the next morning. This rule often conflicts with social habits tied to intimacy.
Insurance coverage adds barriers. Many plans reject Addyi but cover men’s drugs like Viagra without extra steps. Some require mental health checks or trials of other treatments first, steps not needed for men. The retail price runs $1,170 to $1,185 monthly, or over $14,000 yearly, limiting access mostly to those with good insurance.
Past sales fell short of hopes. Wall Street predicted $100 million to $300 million yearly, but 2016 brought just $11 million. Only 227 prescriptions filled nationwide by late 2015, with under 1% of primary care doctors trained via REMS. A rival shot, Vyleesi, approved in 2019, peaked at $12.5 million before selling for $12 million in 2024.
Sprout now targets women aged 50-65, hit by menopause-related hormone drops in estrogen and testosterone. Their small team of 50 markets to a group skeptical from the drug’s history. Success depends on better insurance buy-in, doctor trust, and demand in a market slow to embrace women’s options, where over 20 treatments exist for men but just two for women.
Sources:
“Historic First in Women’s Sexual Health: FDA Grants Approval for Addyi (flibanserin) for Postmenopausal Women.” PR Newswire, December 15, 2025.
Flibanserin.” Wikipedia (citing peer-reviewed clinical data), accessed December 2025.
“Addyi Alcohol Warnings Have Not Been Revised, Says FDA.” EMPR, September 11, 2019.
“FDA OKs Libido-Boosting Pill for Women Who Have Gone Through Menopause.” ABC News, December 15, 2025.
“‘Female Viagra’ Keeps Alcohol Black Box Warning Amid Safety Concerns.” BiopharmaDive, April 11, 2019.
“Behind the Scenes at the FDA: Why They Ultimately Approved Addyi.” BiopharmaDive (citing FDA institutional records and advisory committee minutes), accessed 2025.
“The Score is Even: Lessons from the Addyi Campaign.” Hastings Center Report, June 27, 2022.