Flibanserin

The mechanism of action of ADDYI in the treatment of women less than 65 years of age with acquired, generalized HSDD as characterized by low sexual desire that causes marked distress or interpersonal difficulty (not due a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance) is not known.

• ADDYI 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.

• ADDYI is contraindicated in patients: • Using concomitant moderate or strong CYP3A4 inhibitors [see Boxed Warning and Warnings and Precautions (5.2) ] . • With hepatic impairment [see Boxed Warning and Warnings and Precautions (5.5) ] .contraindicated

• Recommended dosage is 100 mg taken once daily at bedtime (2.1) • ADDYI is dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (2.1) • Discontinue ADDYI treatment after 8 weeks if no improvement (2.3) 2.1 Recommended Dosage The recommended dosage of ADDYI is 100 mg administered orally once per day at bedtime. ADDYI is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation) . 2.2 Missed Dose If a dose of ADDYI is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day. Instruct the patient to not double the next dose. 2.3 Discontinuation of ADDYI Discontinue ADDYI after 8 weeks if the patient does not report an improvement in her HSDD symptoms. 2.4 Initiation of ADDYI Following Moderate or Strong CYP3A4 Inhibitor Use If initiating ADDYI following moderate or strong CYP3A4 inhibitor use, start ADDYI 2 weeks after the last dose of the CYP3A4 inhibitor. If initiating a moderate or strong CYP3A4 inhibitor following ADDYI use, start the moderate or strong CYP3A4 inhibitor 2 days after the last dose of ADDYI [see Warnings and Precautions (5.2) ].

• Hypotension and Syncope due to an Interaction with Alcohol : After taking ADDYI at bedtime, advise patients to avoid alcohol until the following day. (5.1) • Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation) : Can occur with ADDYI alone. Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients should avoid activities requiring full alertness (e.g., driving or operating machinery) until at least six hours after each dose and until they know how ADDYI affects them. (5.3) • Hypotension and Syncope with ADDYI Alone : Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve. (5.4) • Hypersensitivity Reactions, including anaphylaxis, angioedema, pruritus, urticaria : Avoid in women with known hypersensitivity to ADDYI or any of its components ( 5.6 ) 5.1 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 [see Boxed Warning and Adverse Reactions (6.1) ] . Patients who drink three or more standard alcoholic drinks should skip their ADDYI dose that evening. 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).

The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hypotension and syncope [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5) ] • CNS depression [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation and dry mouth. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sprout Pharmaceuticals, Inc. at 1-844-746-5745, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The approved 100 mg ADDYI dosage at bedtime was administered to 2,997 premenopausal women with acquired, generalized HSDD in clinical trials, of whom 1,672 received treatment for at least 6 months, 850 received treatment for at least 12 months, and 88 received treatment for at least 18 months [see Clinical Studies (14) ]. In clinical trials, ADDYI 100 mg once daily at bedtime was administered to 801 postmenopausal women less than 65 years of age with acquired, generalized HSDD, of whom 460 received ADDYI treatment for at least 6 months, and 23 received ADDYI treatment for longer than 6 months.

• Nursing Mothers : ADDYI is not recommended. (8.2) • CYP2C19 Poor Metabolizers : Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression (8.7) 8.1 Pregnancy Risk Summary There are no studies of ADDYI in pregnant women to inform whether there is a drug-associated risk in humans. In animals, fetal toxicity only occurred in the presence of significant maternal toxicity including reductions in weight gain and sedation. In pregnant rats and rabbits, adverse reproductive and developmental effects consisted of decreased fetal weight, structural anomalies and increases in fetal loss at exposures greater than 15 times exposures achieved with the recommended human dosage [see Data ] . Animal studies cannot rule out the potential for fetal harm. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Pregnant rats were administered flibanserin at doses of 0, 20, 80 and 400 mg/kg/day (3, 15 and 41 times clinical exposures at the recommended human dose based on AUC) during organogenesis.

Metabolism

Flibanserin showed dose-proportional pharmacokinetics for Cmax after single oral doses of 100 mg to 250 mg (the recommended and 2.5 times the recommended dosage, respectively) in healthy female subjects. Steady state was achieved after 3 days of dosing.

Overdosage of ADDYI may cause an increase in the incidence or severity of any of the reported adverse reactions [see Warnings and Precautions (5.3, 5.4) and Adverse Reactions (6.1) ]. In the event of overdosage, treatment should address the symptoms and supportive measures, as needed. There is no known specific antidote for flibanserin.

• Aug 18, 2015NDANDA022526Sprout Pharms

1. 1Drug Ineffective55928%
2. 2Dizziness33017%
3. 3Nausea19710.0%
4. 4Somnolence1678.4%
5. 5Product Use In Unapproved Indication1547.8%
6. 6Insomnia1427.2%
7. 7Fatigue1417.1%
8. 8Headache1266.4%
9. 9Feeling Abnormal1015.1%
10. 10Adverse Drug Reaction985.0%
11. 11Malaise814.1%
12. 12Product Use Issue603.0%
13. 13Hypotension582.9%
14. 14Middle Insomnia562.8%
15. 15Anxiety542.7%

The 10 most recently updated of 20 ClinicalTrials.gov registrations naming Flibanserin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Hypoactive Sexual Desire Disorder in Males
  Terminated · Phase 2 · Interventional · 8 enrolled · Mohit Khera
  NCT04002661updated 2026-01-26
• A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors
  Active not recruiting · Phase 2 · Interventional · 43 enrolled · Memorial Sloan Kettering Cancer Center
  NCT03707340updated 2025-11-04
• Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer
  Active not recruiting · Phase 2 · Interventional · 44 enrolled · Andrew McDonald
  NCT04743934updated 2025-05-04
• Effects of Flibanserin on the Pre- and Post-menopausal Female Brain
  Terminated · Interventional · 57 enrolled · University of Chicago
  NCT02770768updated 2024-05-16
• Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
  Terminated · Phase 4 · Interventional · 23 enrolled · San Diego Sexual Medicine
  NCT02714049updated 2022-06-13
• Bioequivalence Study of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)
  Completed · Phase 1 · Interventional · 26 enrolled · Genuine Research Center, Egypt
  NCT04494191updated 2020-07-31
• 12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress
  Terminated · Phase 3 · Interventional · 111 enrolled · Sprout Pharmaceuticals, Inc
  NCT01040208updated 2016-08-24
• 6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
  Completed · Phase 3 · Interventional · 1,385 enrolled · Sprout Pharmaceuticals, Inc
  NCT00360243updated 2016-06-27
• 24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
  Completed · Phase 3 · Interventional · 880 enrolled · Sprout Pharmaceuticals, Inc
  NCT00360529updated 2016-06-27
• Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
  Completed · Phase 3 · Interventional · 1,584 enrolled · Sprout Pharmaceuticals, Inc
  NCT00360555updated 2016-06-27

CPIC-curated drug–gene pairs for Flibanserin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• CYP2C19CPIC C (provisional)FDA label: Actionable PGx
• CYP2C9CPIC C (provisional)FDA label: Informative PGx
• CYP2D6CPIC C (provisional)FDA label: Informative PGx

Frequently asked questions

How does Flibanserin work?

The mechanism of action of ADDYI in the treatment of women less than 65 years of age with acquired, generalized HSDD as characterized by low sexual desire that causes marked distress or interpersonal difficulty (not due a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance) is not known.

What is Flibanserin used for?

According to FDA labeling, Flibanserin carries indications including: ADDYI 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Flibanserin?

Flibanserin is classified as Other gynecologicals, Cytochrome P450 3A4 Inducers, P-Glycoprotein Inhibitors, Decreased Serotonin Activity.

What are the brand names for Flibanserin?

Flibanserin is marketed under brand names including Addyi.

What are the contraindications for Flibanserin?

Flibanserin labeling lists contraindications including: ADDYI is contraindicated in patients: • Using concomitant moderate or strong CYP3A4 inhibitors [see Boxed Warning and Warnings and Precautions (5.2) ] . • With hepatic impairment [see Boxed Warning and Warnings and Precautions (5.5) ] .. Always consult the full prescribing information and a clinician.