At a glance

Uses

Who Addyi is for, and who it is not for

Addyi has one FDA-approved use. It treats women under 65 with acquired, generalized hypoactive sexual desire disorder, or HSDD. Acquired means the low desire developed in a woman who previously had no problem with desire. Generalized means it happens no matter the type of stimulation, the situation or the partner. The low desire must cause marked distress or trouble in the relationship.

Until December 2025 the label limited Addyi to premenopausal women. FDA’s approval of a supplement on December 13, 2025 extended the indication to women under 65 independent of reproductive status. Older handouts and web pages may still say premenopausal only.

Mood, other medicines, hormone changes, pain with sex and the state of the relationship can each lower desire on their own. A physician has to look at those before calling it HSDD. If your desire changed around menopause, read about estradiol, testosterone, our guide to perimenopause and hormones and our post on hormone therapy for women.

How it is taken

How it works, how it is taken and how long to try it

The label states that the way Addyi works in HSDD is not known. In lab studies flibanserin binds serotonin receptors in the brain: it activates 5-HT1A, blocks 5-HT2A, and has moderate blocking activity at 5-HT2B, 5-HT2C and dopamine D4 receptors. You may read that it raises dopamine and norepinephrine and lowers serotonin. The label does not say that, so this page does not either. It is not a hormone.

Dose and timing

The label dose is 100 mg by mouth once a day at bedtime. It is dosed at bedtime because taking it during waking hours raises the risk of low blood pressure, fainting, accidental injury and sedation. Take one tablet at bedtime and do not take it at any other time of day.

If you miss a bedtime dose, take the next dose at bedtime the next day. Do not double it. Avoid driving or operating machinery until at least 6 hours after each dose and until you know how it affects you. In a driving study of 83 healthy premenopausal women, no effect on driving or psychomotor performance was detected 9 hours after bedtime doses.

How long to try it

The label says to discontinue Addyi after 8 weeks if you do not report an improvement in your HSDD symptoms. That is a stopping rule, not a promise that week 8 is when it works. The trials ran 24 weeks, and most side effects began in the first 14 days. Because improvement is your own report of desire, satisfying sex and distress, keep simple notes from the first week so the 8-week check means something.

Boxed warning

Alcohol, low blood pressure and fainting

Addyi carries a boxed warning titled hypotension and syncope in certain settings. It is still on the label. What changed is the alcohol part. When Addyi was approved in 2015, the boxed warning said alcohol was contraindicated and the drug was available only through a restricted program. In October 2019 FDA removed the alcohol contraindication and rewrote the boxed warning around timing.

The current label says:

• Wait at least two hours after one or two standard alcoholic drinks before taking Addyi at bedtime.
• Skip that night’s dose if you have had three or more standard drinks that evening.
• After you take Addyi at bedtime, do not drink alcohol until the following day.
• One standard drink is 12 ounces of regular beer (5% alcohol), 5 ounces of wine (12%) or 1.5 ounces of distilled spirits (40%).

Here is why the rules look like this. In the first alcohol study, 25 healthy volunteers (23 of them men) took Addyi and alcohol together in the morning. Four of the 23 who drank an amount equal to two drinks had low blood pressure or fainting that needed treatment. Later studies in healthy premenopausal women looked at timing. In a crossover study of 64 women, alcohol equal to about two drinks, taken 2, 4 or 6 hours before Addyi, did not raise hypotension, orthostatic hypotension or fainting compared with either one alone.

Low blood pressure and fainting can also happen with Addyi alone. In five 24-week trials in premenopausal women, hypotension was reported in 0.2% of women on Addyi and under 0.1% on placebo, and syncope in 0.4% and 0.2%. If you feel lightheaded, lie down right away and get medical help if it does not pass. Tell your physician if you faint.

Interactions

Medicines and conditions that rule Addyi out

The boxed warning names two more settings, and both are contraindications. The first is any moderate or strong CYP3A4 inhibitor. These drugs slow the liver enzyme that clears flibanserin. In a study with fluconazole, flibanserin exposure rose 7-fold and 3 of 15 women had low blood pressure or fainting. One became unresponsive with a blood pressure of 64/41 and needed IV fluids in an emergency department. The study was stopped early.

• Strong CYP3A4 inhibitors named in the label include ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir and indinavir.
• Moderate inhibitors named in the label include fluconazole, erythromycin, ciprofloxacin, diltiazem, verapamil, amprenavir, atazanavir and grapefruit juice.
• Timing: start Addyi at least 2 weeks after the last dose of an inhibitor. If you need an inhibitor, it should start at least 2 days after your last Addyi dose.
• Liver impairment: any degree is a contraindication. Exposure rose 4.5-fold in women with mild impairment, and the half-life was 26 hours instead of 10.

Other interactions call for a physician’s judgment instead of a flat no. CYP3A4 inducers such as rifampin, carbamazepine, phenytoin and St. John’s wort are not recommended, because rifampin cut flibanserin exposure by 95%. Several weak inhibitors together, including cimetidine, fluoxetine, ginkgo and oral contraceptives, can raise levels. Strong CYP2C19 inhibitors, a group that includes proton pump inhibitors, SSRIs and benzodiazepines, can also raise exposure, and women who are CYP2C19 poor metabolizers have higher levels. Other sedating drugs, such as diphenhydramine, opioids and sleep medicines, add to sleepiness. Addyi raises digoxin levels.

Women who reported using hormonal contraceptives had more dizziness (13.4% versus 9.9%), somnolence (12.3% versus 10.6%) and fatigue (11.4% versus 7.5%) on Addyi than women who did not. The trials were not designed to test that. Tell your physician about every prescription, over-the-counter medicine and supplement you take.

Evidence

What the three phase 3 trials showed

FDA approved Addyi in 2015 based on three 24-week, randomized, double-blind, placebo-controlled trials in premenopausal women with acquired, generalized HSDD. FDA’s review calls them Studies 511.71, 511.75 and 511.147. The label calls them Studies 1, 2 and 3 (ClinicalTrials.gov NCT00360529, NCT00360555 and NCT00996164). They were published as VIOLET, DAISY and BEGONIA. Together, 1,187 women took Addyi 100 mg at bedtime and 1,188 took placebo. Average age was 36, average HSDD duration about 5 years, and 69% of the Addyi group finished versus 78% of the placebo group.

Two of the three trials missed their pre-set daily-diary desire endpoint. The label reports the FSFI desire score, a four-week questionnaire, where all three trials favored Addyi by 0.3 to 0.4 points. That is a small difference on a five-point scale. The label’s own responder analysis shows the size: 43% to 48% of women on Addyi rated themselves much or very much improved on desire, versus 31% to 38% on placebo, a gap of 10 to 13 percentage points. For satisfying events the gap was 8 to 9 points. A 2016 meta-analysis of 5,914 women pooled eight studies, found about one-half additional satisfying event per month, and graded the quality of the evidence as very low.

Postmenopausal women

The December 2025 expansion rests on trials in naturally postmenopausal women. In Study 6 (SNOWDROP), naturally postmenopausal women took Addyi or placebo. The label reports statistically significant improvement in satisfying events, FSFI desire and distress. The event difference was 0.4 per 28 days, and its confidence interval reached zero. A second trial, PLUMERIA (376 on Addyi, 369 on placebo, mean age 56), was stopped early by the sponsor. At week 16 FSFI desire improved significantly, and satisfying events did not. Trials in different populations are not directly comparable.

Side effects

Side effects and what to watch for

The most common side effects in the premenopausal trials, Addyi versus placebo, were:

• Dizziness: 11.4% versus 2.2%.
• Somnolence: 11.2% versus 2.9%.
• Nausea: 10.4% versus 3.9%.
• Fatigue: 9.2% versus 5.5%.
• Insomnia: 4.9% versus 2.8%. Dry mouth: 2.4% versus 1.0%.

Somnolence, sedation or fatigue together were reported by 21% on Addyi and 8% on placebo across five premenopausal trials. Adverse reactions led 13% of premenopausal women on Addyi to stop, versus 6% on placebo. In the postmenopausal trials the numbers were lower: dizziness 7.9% versus 3.3%, somnolence 7.7% versus 1.8% and nausea 6.6% versus 3.9%.

The label also lists appendicitis in 6 of 3,973 women treated with flibanserin and none of 1,905 on placebo. After approval, allergic reactions including anaphylaxis and swelling of the face, lips and mouth were reported. Stop Addyi and get care if that happens. Overdose has no specific antidote.

History

Approval and REMS history

Addyi was FDA’s first approved drug for low desire in women, and its path was long. A REMS, or risk evaluation and mitigation strategy, is an FDA safety program that can go beyond the label.

• 2010 to 2013: After a 2010 advisory committee voted 10 to 1 that efficacy was not shown, and 11 to 0 against an acceptable benefit and risk, FDA declined to approve it. A second Complete Response letter followed in 2013.
• June 4, 2015: A joint advisory committee voted 18 to 6 that benefit and risk were acceptable, but only with risk management beyond labeling.
• August 18, 2015: FDA approved Addyi (NDA 022526) with the alcohol contraindication and a REMS with elements to assure safe use. Prescribers and pharmacies had to be certified, and patient and prescriber completed a Patient-Provider Agreement Form.
• October 9, 2019: FDA removed the certification requirements and the alcohol contraindication, citing phase 1 data that waiting at least 2 hours after up to two standard drinks reduces the risk. The REMS was left as the Medication Guide.
• January 21, 2025: FDA removed the Medication Guide from the REMS and concluded that a REMS is no longer required. The Medication Guide stays part of the labeling.
• December 13, 2025: FDA extended the indication to women under 65 independent of reproductive status.

In practice, any licensed prescriber can now write for Addyi without special enrollment. The boxed warning and the label rules above still apply.

Comparison

How Addyi differs from Vyleesi, estradiol and sildenafil cream

These four can all come up when a woman says her desire has dropped. They are different tools for different causes.

Read the full pages for Vyleesi, estradiol and compounded sildenafil cream. Addyi is the brand-name FDA-approved product and is not compounded. This page does not rank these options, because their trials enrolled different women.

Summit’s role

What Summit does with Addyi

Dr. Miranda can prescribe Addyi after a physician evaluation. That visit covers your history, what is behind the low desire, your blood pressure, your liver health, every medicine and supplement you take, and how much alcohol you drink and when. A pharmacy fills the prescription. Summit does not dispense or sell Addyi.

Nothing on this page promises a prescription. If a contraindication applies to you, or another approach fits better, you will hear why. See pricing for what the program includes and hormone therapy if your symptoms point that direction.

Keep reading

Related medications

Sources

Where this comes from

All retrieved November 10, 2026.

1. ADDYI (flibanserin) tablets prescribing information, revised 12/2025. DailyMed, U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3819daf3-e935-2c53-c527-e1d57922f394
2. FDA. Drugs@FDA: ADDYI, NDA 022526. Approval history, supplements and review documents. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022526
3. FDA. NDA 022526/S-013 supplement approval letter (indication extended to women under 65). December 2025. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022526Orig1s013ltr.pdf
4. FDA. NDA 022526/S-012 supplement approval letter (REMS no longer required). January 2025. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022526Orig1s012ltr.pdf
5. FDA. NDA 022526/S-009 supplement approval letter (REMS modified, certification removed). October 2019. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s009ltr.pdf
6. FDA. Division Director summary review, NDA 022526 (Studies 511.71, 511.75, 511.147; advisory committees). August 2015. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000SumRedt.pdf
7. Derogatis LR et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med 2012. https://pubmed.ncbi.nlm.nih.gov/22248038/
8. Thorp J et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med 2012. https://pubmed.ncbi.nlm.nih.gov/22239862/
9. Katz M et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA trial. J Sex Med 2013. https://pubmed.ncbi.nlm.nih.gov/23672269/
10. Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial. Menopause 2014. https://pubmed.ncbi.nlm.nih.gov/24281236/
11. Portman DJ et al. Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study. J Sex Med 2017. https://pubmed.ncbi.nlm.nih.gov/28583342/
12. Jaspers L et al. Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women: A Systematic Review and Meta-analysis. JAMA Intern Med 2016. https://pubmed.ncbi.nlm.nih.gov/26927498/
13. Simon JA et al. Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. J Sex Med 2019. https://pubmed.ncbi.nlm.nih.gov/31522985/