Update on Flibanserin (ADDYI): Avoid this Low-Libido Drug for Women

Acquired hypoactive sexual desire disorder (HSDD) is characterized by generalized low sexual desire, unrelated to an adverse drug effect, substance use, health condition or relationship problems that causes marked distress. In 2015, flibanserin (ADDYI) was first approved to treat premenopausal women with HSDD.[1] In December 2025, the Food and Drug Administration (FDA) expanded the drug’s approval to include postmenopausal women with HSDD ages 65 years and younger.[2]

Before being studied for HSDD, flibanserin was unsuccessfully developed as an antidepressant. The drug is taken orally as a 100-milligram (mg) tablet once a day. For those paying cash, flibanserin is available for $149, according to the manufacturer. The cost with insurance is less.

How — and if — the drug stimulates sexual desire is not known.

Public Citizen’s Health Research Group urged the FDA not to approve flibanserin because of its unfavorable benefit-risk profile. We have previously classified flibanserin as a Do Not Use drug, and that classification is not changed by the expanded FDA approval.[3],[4]

Background on flibanserin

As discussed in the April 2020 issue of Worst Pills, Best Pills News[5], the FDA twice rejected flibanserin for the treatment of HSDD. The agency was concerned about the drug’s adverse events and minimal benefits.[6],[7] After the second rejection, Sprout Pharmaceuticals, the drug’s sponsor, launched an aggressive lobbying and marketing campaign. As part of the campaign, an advocacy group that the company had partially funded accused the FDA of gender bias. The group claimed that the FDA had approved several medications for sexual dysfunction in men but none in women.[8] In fact, the FDA has not approved any medications for low sexual desire in men.

After the sponsor applied for approval a third time and submitted additional data, the FDA approved flibanserin in 2015. The agency acknowledged, however, that the “average treatment effects were small” and that some of the its own experts continued to recommend against approval.[9] For instance, treatment with flibanserin resulted in a median increase of only one-half to one additional satisfying sexual experience per month compared with placebo in clinical trials (women had a median of about two to three satisfying sexual experiences per month at the beginning of the trial).[10] This small benefit came with increased risks of severe hypotension (low blood pressure) and syncope (fainting), serious risks amplified by 7alcohol or certain medications such as fluconazole (DIFLUCAN and generics)or diltiazem (CARDIZEM, CARTIA XT, TIAZAC and generics).

For this reason, the FDA required a boxed warning — the agency’s most prominent warning — highlighting the risks of hypotension and syncope in certain settings and indicating that women using flibanserin must abstain from alcohol use.[11]

Concerningly, in 2019 the warning about abstaining from alcohol use was removed from the prescribing information.[12] The boxed warning continues to state that due to the risk of severe hypotension and syncope, flibanserin should not be taken by patients with liver problems, together with certain medications, as listed above. Flibanserin doses should be delayed for at least two hours after consuming one or more standard alcoholic drinks (such as one 12-ounce beer) or not be taken at all after three or more drinks.[13]

Efficacy of flibanserin in postmenopausal women

The broadened approval of flibanserin for postmenopausal women was based on one industry-sponsored double-blind trial that was published in 2014.[14],[15] Although the serious safety concerns were comparable to those in premenopausal women, the benefits for postmenopausal women were even smaller than for premenopausal women.

The trial enrolled 949 postmenopausal women in whom menopause occurred without a medical intervention, such as the removal of both ovaries, and with a diagnosis of HSDD. The participants were randomized to either 100 mg of flibanserin or placebo once daily for 24 weeks. Before the trial, the participants had a mean of two satisfying sexual events per 28-day period.[16] After 24 weeks, the number of satisfying sexual events per 28-day period had increased on average by 1 event for women in the flibanserin group and 0.6 events for those in the placebo group. On a 6-point sexual desire subscale, participants in the flibanserin group had a 0.7-point increase after 24 weeks, compared with a 0.4-point increase in the placebo group. Although the 0.3-point difference between groups was statistically significant, a difference this small may not be meaningful for a woman’s perception of sexual activity. For several other standardized questionnaires that are used to assess sexual function, the differences between groups were even more marginal.

The prescribing information for flibanserin also includes data from a second trial that was discontinued early and in which less than half of the participants had completed 16 weeks of treatment.[17],[18] In this trial, which was similar in design to the 2014 trial, the minimal improvements on the sexual function scale with flibanserin compared with placebo again reached statistical significance. The differences between groups for satisfying sexual encounters were not statistically significant, however.

A 2024 systematic review analyzed data from six trials of flibanserin in premenopausal women and the two trials discussed above in postmenopausal women.[19] The analysis found that on average the treatment difference for premenopausal women in the flibanserin group compared with the placebo group was 0.69 more satisfying sexual encounters per month and an increase of 0.30 on the sexual desire scale. For postmenopausal women, the average treatment differences were only 0.37 and 0.25, respectively.

The clinical relevance of the trial results is further called into question by the long list of exclusion criteria. For instance, the 2014 trial excluded women taking certain commonly prescribed medications such as benzodiazepines including alprazolam (XANAX and generics), antidepressants including escitalopram (LEXAPRO and generics), antipsychotics, prescription sleep aids and sedatives. The trial also excluded women with depression, endometriosis, urinary tract or vaginal infections, uncontrolled diabetes, cardiovascular disease or thyroid disorders.[20],[21] In fact, according to the study authors, the trial population “was not entirely reflective of women seeking treatment for distressing low sexual desire in clinical practice.”

Safety concerns

In the 2014 trial, drug-related adverse events, including severe adverse events, were more common in the flibanserin group (29.8% and 6%, respectively) than in the placebo group (12.7% and 3.5%).[22] In addition to the boxed warning for increased risks of severe hypotension and syncope, flibanserin also can cause central nervous system depression (such as somnolence and sedation), which can lead to accidental injuries.[23] Because of these adverse effects, the drug should be taken at bedtime. The most common adverse events associated with flibanserin in postmenopausal women were dizziness, somnolence, nausea and headaches. Of concern, studies of the interaction between flibanserin and alcohol have not been conducted in postmenopausal women.

What You Can Do

If you are a woman experiencing low libido that causes you distress, speak to your clinician about possible causes and nonpharmacological treatment options. If you have been diagnosed with HSDD, do not take flibanserin. Instead, choose an integrative approach to address the underlying factors (whether they are medical, psychological or relational) that may be affecting your condition.
 

References

[1] Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). October 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s008lbl.pdf. Accessed April 5, 2026.

[2] Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). December 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022526s013lbl.pdf. Accessed April 5, 2026.

[3] Public Citizen. Testimony before the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee regarding flibanserin. June 4, 2025. https://www.citizen.org/article/testimony-before-the-fdas-bone-reproductive-and-urologic-drugs-advisory-committee-and-the-drug-safety-and-risk-management-advisory-committee-regarding-flibanserin/#overlay-context=. Accessed March 27, 2026.

[4] Avoid the ‘pink pill’ flibanserin (ADDYI) for low female sexual desire. Worst Pills, Best Pills News. April 2020. https://www.worstpills.org/newsletters/view/1326. Accessed April 5, 2026.

[5] Avoid the ‘pink pill’ flibanserin (ADDYI) for low female sexual desire. Worst Pills, Best Pills News. April 2020. https://www.worstpills.org/newsletters/view/1326. Accessed April 5, 2026.

[6] Food and Drug Administration. FDA Briefing Document. Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee. For Flibanserin, NDA 022526. June 4, 2015. https://wayback.archive-it.org/7993/20170114001012/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM449088.pdf. Accessed April 5, 2026.

[7] Woloshin S, Schwartz LM. US Food and Drug Administration Approval of flibanserin: Even the Score does not add up. JAMA Intern Med. 2016 Apr;176(4):439-442.

[8] Joffe HV, Chang C, Sewell C, et al. FDA approval of flibanserin--Treating hypoactive sexual desire disorder. N Engl J Med. 2016 Jan 14;374(2):101-104.

[9] Ibid.

[10] Food and Drug Administration. FDA Briefing Document. Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee. For Flibanserin, NDA 022526. June 4, 2015. https://wayback.archive-it.org/7993/20170114001012/http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM449088.pdf. Accessed April 5, 2026.

[11] Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). August 2015. Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). December 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf. Accessed March 27, 2026.

[12] Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). October 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s008lbl.pdf. Accessed April 5, 2026.

[13] Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). December 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022526s013lbl.pdf. Accessed April 5, 2026.

[14] Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). December 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022526s013lbl.pdf. Accessed March 27, 2026.

[15] Simon JA, Kingsberg SA, Shumel B, et al. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014 Jun;21(6):633-640.

[16] Ibid.

[17] Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). December 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022526s013lbl.pdf. Accessed April 6, 2026.

[18] Portman DJ, Brown L, Yuan J, et al. Flibanserin in postmenopausal women with hypoactive sexual desire disorder: Results of the PLUMERIA study. J Sex Med. 2017 Jun;14(6):834-842.

[19] Kamrul-Hasan ABM, Hannan MA, Alam MS, et al. Role of flibanserin in managing hypoactive sexual desire disorder in women: A systematic review and meta-analysis. Medicine (Baltimore). 2024 Jun 21;103(25):e38592.

[20] Simon JA, Kingsberg SA, Shumel B, et al. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014 Jun;21(6):633-640.

[21] Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). December 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022526s013lbl.pdf. Accessed April 6, 2026.

[22] Simon JA, Kingsberg SA, Shumel B, et al. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause. 2014 Jun;21(6):633-640.

[23] Sprout Pharmaceuticals. Label: Flibanserin (ADDYI). December 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022526s013lbl.pdf. Accessed April 6, 2026.