there was a pill to improve a woman’s sex drive?

The only FDA-approved pill proven safe and effective for Hypoactive Sexual Desire Disorder (HSDD) premenopausal women. And now you can dispense Addyi to her directly from your office.

there was a pill to improve a woman’s sex drive?

The only FDA-approved pill proven safe and effective for Hypoactive Sexual Desire Disorder (HSDD) premenopausal women. And now you can dispense Addyi to her directly from your office.

If She’s Stressed

That she’s never in the mood,

it could be hsdd

Addyi is the #1 prescribed treatment for HSDD1 in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner.

Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to: a medical or mental health problem, problems in the relationship or medicine or other drug use.

ADDYI is not for use for the treatment of HSDD in women who have gone through menopause or in men or children. ADDYI is not for use to enhance sexual performance.

If She’s Stressed That she’s never

in the mood, it could be hsdd

Addyi is the #1 prescribed treatment for HSDD1 in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner.

Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to: a medical or mental health problem, problems in the relationship or medicine or other drug use.

ADDYI is not for use for the treatment of HSDD in women who have gone through menopause or in men or children. ADDYI is not for use to enhance sexual performance.

70% of Patients

WANT YOU TO START THE CONVersation ABOUT SEXUAL HEALTH2

“I was stressed over sex! I was never in the mood and had no desire… I learned I was dealing with HSDD – then I found Addyi! All I can say is OMG!”

– Sarah H, 44

“I love my partner but I’ve lost that inner sexy I once felt. It’s not them, it’s not depression, it’s like an internal switch went out. I want to turn back on!”

– Melissa H, 38

“I was stressed over sex! I was never in the mood and had no desire… I learned I was dealing with HSDD – then I found Addyi! All I can say is OMG!” – Sarah H, 44

“I love my partner but I’ve lost that inner sexy I once felt. It’s not them, it’s not depression, it’s like an internal switch went out. I want to turn back on!” – Melissa H, 38

In as little as 4 weeks

Women may experience results in as little as 4 weeks but set her expectations to give Addyi 2 months to experience full effects. Let her know she may begin to notice sexual fantasies returning, become more receptive to her partner, and even initiate sex herself.*

*Not all women will experience similar improvement in their HSDD. Some women may see results in as early as 4 weeks. Addyi should be discontinued if there is no improvement after 8 weeks.

In as little as 4 weeks

Women may experience results in as little as 4 weeks but set her expectations to give Addyi 2 months to experience full effects. Let her know she may begin to notice sexual fantasies returning, become more receptive to her partner, and even initiate sex herself.*

*Not all women will experience similar improvement in their HSDD. Some women may see results in as early as 4 weeks. Addyi should be discontinued if there is no improvement after 8 weeks.

Contact Us

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

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

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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 and Medication Guide, 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.
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