Contact Us
MEDICAL INFO:
844-746-5745 x 3
medicalaffairs@sproutpharma.com
Contact Us
MEDICAL INFO:
844-746-5745 x 3
medicalaffairs@sproutpharma.com
- IQVIA Monthly Total Prescriptions Volume Data Comparing Addyi vs Vyleesi in the US. September 2024–August 2025
- 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
- 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
- Www.medicalnewstoday.com, 30 Nov. 2022, www.medicalnewstoday.com/articles/hypoactive-sexual-desire-disorder#overview
- 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.
- 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.
- Addyi Prescribing Information.
- https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers
- 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.
- 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.
- 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.
- 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.
- Holstege G. How the emotional motor system controls the pelvic organs. Sex Med Rev. 2016: 4;303-328.
- Kingsberg SA. Attitudinal survey of women living with low sexual desire. J Women’s Health. 2014;23(10):817-23
- 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
- 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.
- 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
- 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.
INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
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.
INDICATION
ADDYI (flibanserin) is indicated for the treatment of women less than 65 years of age 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 problems 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 in men.
- ADDYI is not indicated to enhance sexual performance.
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: See Boxed Warning for risks associated with alcohol consumption. After taking ADDYI at bedtime, advise patients to not use alcohol until the following day.
- Hypotension and Syncope with CYP3A4 Inhibitors: See Boxed Warning and Contraindication about use with moderate or strong cytochrome P450 3A4. 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. 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 is increased if ADDYI is taken during waking hours or if higher than the recommend dose is taken.
- 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
- 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.
- CYP3A4 Inducers: Use of ADDYI not recommended, flibanserin concentrations substantially reduced
- Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.
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 and Medication Guide, including Boxed Warning regarding hypotension and syncope in certain settings.
INDICATION
ADDYI (flibanserin) is indicated for the treatment of women less than 65 years of age 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 use in men.
- ADDYI is not indicated to enhance sexual performance.
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: See Boxed Warning for risks associated with alcohol consumption. After taking ADDYI at bedtime, advise patients to not use alcohol until the following day.
- Hypotension and Syncope with CYP3A4 Inhibitors: See Boxed Warning and Contraindication about use with moderate or strong cytochrome P450 3A4. 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. 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 is increased if ADDYI is taken during waking hours or if higher than the recommend dose is taken.
- 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
- 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.
- CYP3A4 Inducers: Use of ADDYI not recommended, flibanserin concentrations substantially reduced
- Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.
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 and Medication Guide, including Boxed Warning regarding hypotension and syncope in certain settings.