Frequently Asked Questions

Frequently Asked Questions

How does Addyi Work

Preclinical studies have shown that flibanserin is a highly selective postsynaptic serotonin (5HT)1A antagonist and 5HT2A antagonist and may also act as an antagonist at 5HT2C and 5HT2B receptors and dopamine D4 receptors.7,15

Allthough the exact mechanism of action is unknown, collectively, these effects are believed to increase dopamine and norepinephrine, and transiently decrease serotonin, to restore the appropriate balance of excitatory and inhibitory activity of brain reward centers to the prefrontal cortex.15

How long will it take to feel the effects of Addyi?

In clinical trials, improvements in HSDD symptoms (increase in sexual desire, increase in satisfying sexual events, decrease in associated distress) were observed as early as 4 weeks after starting Addyi. Not all women will experience similar improvement in their HSDD.7

Improvements can be subtle at first, with gradual improvement. It is important to follow up with women prescribed Addyi to discuss improvements in their HSDD symptoms. Addyi should be discontinued if there is no improvement after 8 weeks.7

Is it safe to drink alcohol and take Addyi?

Taking Addyi after consuming alcohol increases the risk of severe hypotension and syncope. To reduce this risk, counsel patients to wait at least two hours after drinking one or two standard alcoholic drinks* before taking Addyi at bedtime. Counsel patients who drink three or more standard alcoholic drinks to skip their Addyi dose that evening. After taking Addyi at bedtime, advise patients to not use alcohol until the following day.7

Is Addyi a hormonal medication?

No, Addyi is not a hormone or a hormonal treatment. Addyi is a centrally acting multifunctional serotonergic agonist and antagonist. Based on findings from preclinical studies, it is thought that Addyi transiently decreases serotonin activity and increases dopamine and norepinephrine activity to restore an appropriate balance of excitatory and inhibitory activity of the brain reward centers to the prefrontal cortex. The exact mechanism of action is unknown.15

Is there a coupon for Addyi?

Through PhilRX the Addyi coupon is automatically applied.

*Eligible patients only. Restrictions apply. See Terms and Conditions.

How much does Addyi cost?

With insurance coverage?
Addyi is as low as $20 per month.

Is your patient paying cash?
Addyi is $149 per month.

Does your patient need a coupon for her local pharmacy?
If your patient prefers an in-person pharmacy, have her visit goodrx.com/addyi and redeem a coupon for Addyi.

Will my patient’s desire go away if they stop taking Addyi?

Addyi is taken once daily at bedtime to treat hypoactive sexual desire disorder (HSDD) symptoms. Addyi is not a cure for HSDD. Women who experienced improvements in their HSDD symptoms, including an increase in sexual desire, a decrease in associated distress, and an increase in satisfying sexual events, may notice that their symptoms return once they stop taking Addyi.16

Is tapering required? Are there any withdrawal effects?

Patients who want to stop taking Addyi do not need to taper their Addyi tablets. Abrupt discontinuation of Addyi is not associated with withdrawal symptoms.

During a randomized trial in 738 women with HSDD, adverse events associated with withdrawal from CNS medications (specifically serotonergic medications) were compared among women who had taken Addyi for 48 weeks vs women who had taken Addyi for 24 weeks followed by placebo for 24 weeks. No evidence of withdrawal reactions was observed following the abrupt discontinuation of flibanserin after 24 or 48 weeks of treatment.16

What are the common side effects?

The most common adverse reactions occurring in < 2% of women treated with Addyi 100 mg at bedtime (n=1543) and at a higher incidence than with placebo (n=1556), during the clinical trials, were dizziness (11.4%), somnolence (11.2%), nausea (10.4%), fatigue (9.2%), insomnia (4.9%), and dry mouth (2.4%). Most of these adverse reactions began within the first 14 days of starting Addyi.

Less common adverse reactions occurring in ≥1% but <2% of Addyi-treated women and at a higher incidence than with placebo during these clinical trials include anxiety (1.8%), constipation (1.6%), abdominal pain (1.5%), metrorrhagia (1.4%), rash (1.3%), sedation (1.3%) and vertigo (1%).7

What are the long term side effects of Addyi?

Most clinical studies of women with hypoactive sexual desire disorder (HSDD) evaluated 24 weeks of Addyi treatment. However, one long-term safety study looked at the safety of various doses of flibanserin (N=1723) over an extended 52-week treatment period. During this study, 883 women took the FDA-approved Addyi 100 mg dose for ≥180 days.

The most common adverse events reported during the 52-week study were similar to those observed in the 24-week studies, including somnolence (15.8%), sedation (1.6%), fatigue (7.6%), dizziness (6.9%), nausea (6.3%) and vomiting (1.4%). The most common adverse events leading to early study discontinuation included depression (1.1%), anxiety (0.9%), dizziness (0.8%), fatigue (0.7%), and insomnia (0.6%).17

Do patients gain weight while taking Addyi?

Taking Addyi once daily at bedtime is not associated with weight gain.

In the clinical trials for Addyi, body weight was measured at the beginning and during the 24-week study period to assess weight changes. Among women enrolled in these clinical trials, weight gain ≥7% at the end of the study compared to when they started the study occurred in 1.8% of Addyi-treated women compared to 3.4% of women who received placebo.18

What are the drug interactions with Addyi?
Alcohol
Clinical Implications The coadministration of ADDYI with alcohol increased the risk of hypotension syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone.
Preventing or Managing DI Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more alcoholic drinks that evening.
Other CNS Depressants Diphenhydramine, opioids, hypnotics, benzodiazepines
Clinical Implications The concomitant use of ADDYI with CNS depressants may increase the risk of CNS depression (e.g., somnolence) compared to the use of ADDYI alone.
Preventing or Managing DI Discuss the concomitant use of other CNS depressants with the patient when prescribing ADDYI.
Moderate or Strong CYP3A4 Inhibitors Strong: Oral contraceptives, cimetidine, fluxetine, ginkgo, ranitidine
Moderate: Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice
Clinical Implications The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors increases flibanserin exposure compared to the use of ADDYI alone. The risk of hypotension and syncope is increased with concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors.
Preventing or Managing DI The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors is contraindicated.
Weak CYP3A4 Inhibitors Oral contraceptives, cimetidine, fluxetine, ginkgo, ranitidine
Clinical Implications The concomitant use of ADDYI with multiple weak CYP3A4 inhibitors may increase the risk of adverse reactions.
Preventing or Managing DI Discuss the use of multiple weak CYP3A4 inhibitors with the patient when prescribing ADDYI.
Strong CYP2C19 Inhibitors Proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, antifungals
Clinical Implications The concomitant use of ADDYI with strong CYP2C19 inhibitors may increase flibanserin exposure which may increase the risk of hypotension, syncope, and CNS depression.
Preventing or Managing DI Discuss the use of a strong CYP2C19 inhibitor with the patient when prescribing ADDYI.
CYP3A4 Inducers Carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John’s Wort
Clinical Implications The concomitant use of ADDYI with CYP3A4 inducers substantially decreases flibanserin exposure compared to the use of ADDYI alone.
Preventing or Managing DI The concomitant use of ADDYI with CYP3A4 inducers is not recommended.
Digoxin or Other P-glycoprotein Substrates Digoxin, Sirolimus
Clinical Implications The concomitant use of ADDYI with digoxin, a drug that is transported by P-glycoprotein (P-gp), increases the digoxin concentration. This may lead to digoxin toxicity.
Preventing or Managing DI Increase monitoring of concentrations of drugs transported by P-gp that have a narrow therapeutic index (e.g., digoxin).
Where can I find clinical information?

You can read more about clinical trials here.

For more complete medical information, click here.

Contact Us

844-PINK-PILL (844-746-5745)
info@addyihcp.com

MEDICAL INFO:
844-746-5745 x 4
medicalaffairs@sproutpharma.com

Start Prescribing Addyi
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Contact Us

844-PINK-PILL (844-746-5745)
info@addyihcp.com

MEDICAL INFO:
844-746-5745 x 4
medicalaffairs@sproutpharma.com

Start Prescribing Addyi
Instagram

References

  1. IQVIA Monthly Total Prescriptions Volume Data Comparing Addyi vs Vyleesi in the US. April 2024–April 2026
  2. Ryan KL, Arbuckle-Bernstein V, Smith G, Phillips J. Let’s Talk About Sex: A Survey of Patients’ Preferences When Addressing Sexual Health Concerns in a Family Medicine Residency Program Office. PRiMER. 2018;2:23. https://doi.org/10.22454/PRiMER.2018.728252
  3. Stahl SM, et al. Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. J Sex Med. 2011;8:15-27
  4. Www.medicalnewstoday.com, 30 Nov. 2022, www.medicalnewstoday.com/articles/hypoactive-sexual-desire-disorder#overview
  5. Gerstenberger EP, Rosen RC, Brewer JV, et al. Sexual desire and the Female Sexual Function Index (FSFI): a sexual desire cutpoint for clinical interpretation of the FSFI in women with and without hypoactive sexual desire disorder. J Sex Med. 2010;7(9):3096–3103.
  6. Rosen R, Brown C, Heiman J, et al. The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2006; 26:2, 191-208.
  7. Addyi Prescribing Information.
  8. https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers
  9. Clayton AH, Harry AC, Yuan J, et al. Safety of flibanserin in women treated with antidepressants: A randomized, placebo-controlled study. J Sex Med 2018;15(1):43-51.
  10. Arnow BA, Millheiser L, Garrett A et al. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. Neuroscience 2009;158:484-502.
  11. Woodard TL, Nowak NT, Balon R et al. Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study. Fertil Steril 2013;100:1068-1076.
  12. Bianchi-Demicheli F, Cojan Y, Waber L, et al. Neural basis of hypoactive sexual desire disorder in women: an event-related fmri study. J Sex Med. 2011;8:2546-2559.
  13. Holstege G. How the emotional motor system controls the pelvic organs. Sex Med Rev. 2016: 4;303-328.
  14. Kingsberg SA. Attitudinal survey of women living with low sexual desire. J Women’s Health. 2014;23(10):817-23
  15. Clayton AH, Brown L, Kim NN. Evaluation of safety for flibanserin. Expert Opin Drug Saf. 2020;19(1):1-8. doi:10.1080/14740338.2020.1707804
  16. Goldfischer ER, Breaux J, Katz M et al. Continued efficacy and safety of flibanserin in premenopausal women with hypoactive sexual desire disorder (HSDD): Results from a randomized withdrawal trial. J Sex Med.2011; 8:3160-3172.
  17. Jayne C, Simon JA, Taylor LV, Kimura T, Lesko LM; SUNFLOWER study investigators. Open-label extension study of flibanserin in women with hypoactive sexual desire disorder. J Sex Med. 2012;9(12):3180-3188. doi:10.1111/j.1743-6109.2012.02942.x
  18. Kornstein SG, James JA, Apfel SC, et al. Effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with hypoactive sexual desire disorder: A post hoc analysis. J Women’s Health. 2017;26(11):1161-1168. 

Important Safety Information

WARNING: RISK OF HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS

See full prescribing information for complete boxed warning.

  • Use of ADDYI and alcohol together close in time increases this risk. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more standard alcoholic drinks that evening.
  • Use of ADDYI is contraindicated with strong or moderate CYP3A4 inhibitors or in patients with hepatic impairment.

Contraindications

  • Moderate or strong CYP3A4 inhibitors
  • Hepatic impairment
  • Known hypersensitivity to ADDYI or any of its components. Reactions, including anaphylaxis, angioedema, pruritus, and urticaria have been reported.

Warnings and Precautions

  • Hypotension and Syncope Due to Alcohol Interaction: See Boxed Warning.
  • Hypotension and Syncope with CYP3A4 Inhibitors: See Boxed Warning and Contraindications. Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) may also increase the risk.
  • Central Nervous System (CNS) Depression: The risk is increased if ADDYI is taken during waking hours; with alcohol; with other CNS depressants; or with CYP3A4 inhibitors. Patients should avoid activities requiring full alertness (e.g., driving or operating machinery) until at least 6 hours after taking ADDYI and until they know how it affects them.
  • Hypotension and Syncope with ADDYI Alone: The risk is increased if ADDYI is taken during waking hours or if higher than the recommended dose is taken.
  • Syncope and Hypotension in Patients with Hepatic Impairment: See Contraindications.
  • Hypersensitivity Reactions: See Contraindications. Immediately discontinue ADDYI and initiate appropriate treatment if hypersensitivity reaction occurs.

Drug Interactions

  • Oral Contraceptives and Other Weak CYP3A4 Inhibitors: Increases flibanserin exposures and incidence of adverse reactions.
  • Strong CYP2C19 Inhibitors: Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression.
  • Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.

Most Common Adverse Reactions

  • Most common adverse reactions (≥2% and higher than placebo) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation and dry mouth

Please see accompanying full Prescribing Information including BOXED WARNING at ADDYI.com/PI

Indication

ADDYI is indicated for the treatment of women < 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD), characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to: a co-existing medical or psychiatric condition; problems within the relationship; or the effects of a medication or other drug substance.

Limitations of Use: ADDYI is not for use in men or to enhance sexual performance.