Frequently Asked Questions

Frequently Asked Questions

How does Addyi work?

The exact mechanism of action by which Addyi increases sexual desire in women with HSDD is unknown.4

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.4,21

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.21

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.4

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.4

Is it safe to drink alcohol and take Addyi?

Taking Addyi within two hours 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.4

*One standard alcoholic drink contains 14 grams of pure alcohol and is equivalent to one 12-ounce regular beer (5% alcohol), 5-ounces wine (12% alcohol), or 1.5 ounces of distilled spirits/shot (40% alcohol).

Is Addyi a hormonal medication?

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 precise mechanism of action by which Addyi enhances sexual desire in women with hypoactive sexual desire remains unknown.21

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.22

Is tapering required? Are there any withdrawl 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 premenopausal 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.22

What are the side effects?

The most common adverse reactions occurring in more than 2% of premenopausal women with hypoactive sexual desire disorder treated with Addyi 100 mg at bedtime (n=1543) and at a higher incidence than with placebo (n=1556), during the randomized, double-blind, placebo-controlled 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%).4

What are the long term side effects of Addyi?

Most clinical studies of premenopausal 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%).23

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.12

Additional information regarding weight changes can be found here.

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 3
medicalaffairs@sproutpharma.com

START DISPENSING ADDYI

Contact Us

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

MEDICAL INFO:
844-746-5745 x 3
medicalaffairs@sproutpharma.com

START DISPENSING ADDYI

References

  1. IQVIA Monthly Total Prescriptions Volume Data Comparing Addyi vs Vyleesi in the US. September 2022 – August 2023
  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. Addyi Prescribing Information.
  5. Derogatis LR, Komer L, Katz M, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med. 2012;9(4):1074-1085.
  6. Thorp J, Simon J, Dattani D, et al. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med. 2012;9(3):793-804.
  7. Katz M, Derogatis LR, Ackerman R, et al. Efficacy of flibanserin in women with hypoactive sexual desire disorder: results from the BEGONIA Trial. J Sex Med. 2013;10(7):1807-1815.
  8. 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.
  9. 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.
  10. Simon JA, Thorp J, Millheiser L. Flibanserin for Premenopausal Hypoactive Sexual Desire Disorder: Pooled Analysis of Clinical Trials. J Womens Health. 2019;28(6):769-777
  11. Simon JA, Clayton AH, Goldstein I, et al. Effects of Flibanserin on Subdomain Scores of the Female Sexual Function Index in Women With Hypoactive Sexual Desire Disorder. Sex Med. 2022 Dec;10(6):100570.
  12. 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.
  13. https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. Holstege G. How the emotional motor system controls the pelvic organs. Sex Med Rev. 2016: 4;303-328.
  19. Shifren JL, Monz BU, Russo PA, et al. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008 Nov;112(5):970-978.
  20. Kingsberg SA. Attitudinal survey of women living with low sexual desire. J Women’s Health. 2014;23(10):817-23
  21. 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
  22. 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.
  23. 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
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IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING AND INDICATION

WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS
See full prescribing information for complete boxed warning.

  • Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope. 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.
  • Severe hypotension and syncope can occur when ADDYI is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, ADDYI use in these settings is contraindicated.

 

Contraindications

  • Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors
  • Hepatic impairment
  • Known hypersensitivity to ADDYI or any of its components. Reactions, including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported.

Warnings and Precautions

  • Hypotension and Syncope Due to an Interaction with Alcohol: Taking ADDYI within two hours 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. Patients who drink three or more standard alcoholic drinks should skip their ADDYI dose that evening. After taking ADDYI at bedtime, advise patients to not use alcohol until the following day.
  • Hypotension and Syncope with CYP3A4 Inhibitors: Moderate or strong CYP3A4 inhibitors significantly increase ADDYI concentrations, which can lead to hypotension and syncope. Concomitant use of ADDYI with a moderate or strong CYP3A4 inhibitor is contraindicated. Concomitant use of multiple weak CYP3A4 inhibitors that may include herbal supplements (e.g., ginkgo, resveratrol) or non-prescription drugs (e.g., cimetidine) could also lead to clinically relevant increases in flibanserin concentrations that may increase the risk of hypotension and syncope.
  • Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with ADDYI alone and is exacerbated by other CNS depressants including alcohol, and in settings where flibanserin concentrations are increased such as CYP3A4 inhibitors. The risk of CNS depression is also increased if ADDYI is taken during waking hours. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least six hours after each dose and until they know how ADDYI affects them.
  • Hypotension and Syncope with ADDYI Alone: The use of ADDYI - without other concomitant medications known to cause hypotension or syncope - can cause hypotension and syncope. The risk of hypotension and syncope is increased if ADDYI is taken during waking hours or if higher than the recommend dose is taken. Consider the benefits of ADDYI and the risks of hypotension and syncope in patients with pre-existing conditions that predispose to hypotension. Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve. Prompt medical attention should also be obtained for patients who experience syncope.
  • Syncope and Hypotension in Patients with Hepatic Impairment: Any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension and syncope. ADDYI is contraindicated in patients with hepatic impairment.
  • Hypersensitivity Reactions: Reactions including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported with ADDYI. Immediately discontinue ADDYI and initiate appropriate treatment if hypersensitivity reaction occurs.

Drug Interactions

  • Alcohol: coadministration of ADDYI with alcohol increased the risk of hypotension, syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone. Patients should 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.
  • CNS Depressants: (i.e., diphenhydramine, opioids, hypnotics, benzodiazepines, etc.) Concomitant use with ADDYI may increase the risk of CNS depression compared to use of ADDYI alone.
  • Moderate or Strong CYP3A4 Inhibitors: ADDYI is contraindicated in women taking moderate (e.g., fluconazole, etc.) or strong (e.g., ketoconazole, etc.) CYP3A4 inhibitors.
  • Oral Contraceptives and Other Weak CYP3A4 Inhibitors: In combination with ADDYI may increase the risk of adverse reactions.
  • Strong CYP2C19 Inhibitors: (i.e., proton pump inhibitors, SSRI’s, benzodiazepines, antifungals, etc.) Increase flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression.
  • CYP3A4 Inducers: (i.e., carbamazepine, phenobarbital, etc.) Concomitant use substantially decreases flibanserin exposure compared to the use of ADDYI alone and is not recommended.
  • Digoxin or other P-glycoprotein (P-gp) substrates: Increases digoxin concentration, which may lead to digoxin toxicity. Increase monitoring of drugs transported by P-gp that have a narrow therapeutic index.

Most Common Adverse Reactions

  • Most common adverse reactions (ADDYI incidence ≥2% and higher than placebo) are dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.

See Full Prescribing Information including Boxed Warning regarding hypotension and syncope in certain settings at addyi.com/pi.

INDICATION

ADDYI (flibanserin) is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as 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.

Acquired HSDD refers to HSDD that develops in a patient who previously had no problem with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner.

Limitations of Use:

  • ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men.
  • ADDYI is not indicated to enhance sexual performance.