Understanding Female Libido and Hormonal Balance

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, 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.

The research behind the “pink pill”

IQVIA Monthly Total Prescriptions Volume Data in the US. MEDICAL INFO: 844-746-5745 x 3 medicalaffairs@sproutpharma.com MEDICAL INFO: 844-746-5745 x 3 medicalaffairs@sproutpharma.com IQVIA Monthly Total Prescriptions Volume Data Comparing Addyi vs Vyleesi in the US. 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. Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder.

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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. The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. Safety of flibanserin in women treated with antidepressants: A randomized, placebo-controlled study. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation, or partner. ADDYI is not indicated to enhance sexual performance. Moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors Known hypersensitivity to ADDYI or any of its components. Reactions, including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported. 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.

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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.

Boxed Warnings with Addyi

If you have had three or more drinks with alcohol in them, you should skip your dose of Addyi that evening. Once you have taken Addyi in the evening, you should not drink any alcohol until at least the next day. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are using any of the following before taking Addyi. Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety Ketoconazole, itraconazole (Sporanox, Tolsura), posaconazole (Noxafil), fluconazole (Diflucan), or voriconazole (Vfend), which is a medicine used for fungal infections Clarithromycin, erythromycin, or ciprofloxacin, which is an antibiotic used for bacterial infections Diltiazem (Cardizem CD and others) or verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure and other conditions Any medicine for seizures, such as carbamazepine, phenytoin, or phenobarbital A selective serotonin reuptake inhibitor (SSRI), such as fluoxetine, paroxetine, or sertraline, which is a medicine commonly used for anxiety and depression A medicine for HIV, AIDS, or hepatitis C Cimetidine, ranitidine, or a proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex) Rifampin (Rifadin) or rifapentine (Priftin), which is a medicine commonly used to treat an infection called tuberculosis Rifabutin (Mycobutin), which is a medicine used to prevent Mycobacterium avium complex infection Digoxin (Lanoxin), which is a medicine used to treat irregular heartbeat and some types of heart failure Nefazodone, which is used to treat depression Conivaptan (Vaprisol), which is used to treat low blood sodium levels St.

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John’s wort, which is a supplement that may be used to treat depression Ginkgo, which is a supplement used for memory and blood flow Resveratrol, which is a supplement used for weight loss and allergies Sirolimus (Rapamune), which is commonly used to prevent rejection of a transplanted organ A benzodiazepine, such as clonazepam (Klonopin), diazepam (Valium and others), or lorazepam (Ativan and others), which is a medicine used for anxiety, muscle spasms, or seizures Many other medicines may alter the blood levels of Addyi, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken. This may not be a complete list of medicines that can interact with Addyi. If you or someone else has used too much Addyi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222. If you miss a dose, skip the missed dose. 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.

Country	Regulations Status	Approval Process	Regulatory Body
USA	FDA regulates dietary supplements	Requires safety testing before sale	FDA
EU	Classified as food supplements	Compliance with EFSA standards	EFSA, local authorities
Australia	TGA oversees supplement safety	Pre-market assessment	TGA
Canada	Health Canada regulates dietary supplements	Licensing required	Health Canada

Syncope and Hypotension in Patients with Hepatic Impairment: Any degree of hepatic impairment significantly increases flibanserin concentrations, which can lead to hypotension and syncope.

• Pink pills are designed to be visually appealing to women.
• They sometimes include flower extracts like hibiscus.
• Pink pills can support mental focus and alertness.
• Some formulations aim to reduce menopausal hot flashes.
• They are often part of natural health approaches.
• Regular use might lead to hormone stabilization.
• Pink pills are sometimes used to enhance overall feminine vitality.
• They are typically taken with meals to improve absorption.
• Supplements should be used as directed for safety.
• The popularity of pink pills is driven by health trends.
• Scientific evidence varies for many pink pill ingredients.

ADDYI is contraindicated in patients with hepatic impairment.

• Ingredients like maca root are sometimes added to pink pills.
• Pink pills can support hormonal health during postpartum.
• A healthy lifestyle amplifies supplement benefits.
• They may contain natural extracts for digestive health.
• The shelf life of pink pills is generally 2-3 years.
• Storage in cool, dry places prolongs effectiveness.
• Manufacturers may claim they improve sexual satisfaction.
• Research on pink pills' efficacy is limited but ongoing.
• Some pink pills are designed specifically for women's wellness.
• They can be part of daily vitamin routines.
• Consumers should look for third-party testing labels.

Hypersensitivity Reactions: Reactions including anaphylaxis, reactions consistent with angioedema, pruritus, and urticaria have been reported with ADDYI.

• Pink pills are sometimes combined with other supplements, like biotin.
• They can help improve hydration and skin elasticity.
• Some formulations include synbiotics for gut health.
• They are part of natural hormone support strategies.
• Pink pills may aid in muscle recovery after workouts.
• Active ingredients vary widely between brands.
• Benefits may take weeks to become noticeable.
• Consistency and patience are key to results.
• Always check for potential interactions with medications.
• Pink pills can be a boost during stressful periods.
• Use as part of a holistic approach to health.

Immediately discontinue ADDYI and initiate appropriate treatment if hypersensitivity reaction occurs. Oral Contraceptives and Other Weak CYP3A4 Inhibitors: Increases flibanserin exposures and incidence of adverse reactions.

Why the Addyi story matters

Take the next dose at bedtime the next day. Do not take double or extra doses. This survey is being conducted by the WebMD marketing sciences department. The only FDA-approved pill proven safe and effective for Hypoactive Sexual Desire Disorder (HSDD) in BOTH premenopausal and postmenopausal women (<65). 70% of women want you to start the convo about sexual health.2 70% of women want you to start the convo about sexual health.2 The exact mechanism of action of Addyi is unknown.

Supplement for Men and Women

I testified at the FDA 10 years ago when Addyi was approved — a watershed moment that validated women’s sexual health with the first FDA approved option to treat women with frustrating low libido. In my practice, it opened conversations that had long been silenced and gave patients hope. “Addyi has helped me get my libido back. My sweet husband has been so patient with me for years now – I dreaded his advances – I can’t tell you how wonderful it has been to want sex again.” “When I heard about Addyi, I was curious if it would work for me. After only a few weeks on Addyi I’m already thinking about and wanting sex again!” “I used to dread going to bed with my husband, because I was never in the mood… he thought it was his fault. 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.

Real Science. Real Results.

Neural basis of hypoactive sexual desire disorder in women: an event-related fmri study. Holstege G. How the emotional motor system controls the pelvic organs. Attitudinal cenforce tablets survey of women living with low sexual desire. Continued efficacy and safety of flibanserin in premenopausal women with hypoactive sexual desire disorder (HSDD): Results from a randomized withdrawal trial.

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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. Effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with hypoactive sexual desire disorder: A post hoc analysis. 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. 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.

• Pink pills often target women’s reproductive health.
• They may include vitamins like D and E for immunity.
• Certain ingredients are chosen for their antioxidant properties.
• Pink pills can support mood stability during hormonal fluctuations.
• They may be used to improve sleep patterns.
• Some brands promote organic, non-GMO ingredients.
• Users may experience improved overall wellbeing.
• Supplements are more effective when combined with stress management.
• Women should monitor their body's reactions to new supplements.
• Regular health check-ups complement supplement use.
• Pink pills are sometimes part of prenatal or postnatal routines.