FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder

This medication should only be taken at bedtime. Do not take this medication with grapefruit juice. If you have 1 or 2 alcohol-containing drinks, wait at least 2 hours before taking this medication at bedtime.

• Flibanserin's prescribing information highlights the risk of severe hypotension.
• The drug’s efficacy is evaluated via sexual desire and satisfaction questionnaires.
• It is meant to be part of a comprehensive approach to female sexual dysfunction.
• Some women report improved libido and satisfaction after consistent use.
• Flibanserin can impair alertness, affecting daily activities.
• Medical professionals should counsel patients thoroughly before initiating therapy.
• The medication is not recommended in women with certain pre-existing health conditions.
• Insurance approval may require documentation of HSDD diagnosis.
• Long-term use data for flibanserin is limited, and ongoing studies are necessary.

Do not take your bedtime dose if you have consumed 3 or more alcohol-containing drinks.

After taking this medication at bedtime, do not drink alcohol until the next day. A special MedGuide will be given to you by the pharmacist with each prescription and refill.

• Flibanserin's mechanism involves increasing dopamine and norepinephrine and decreasing serotonin levels.
• It does not address libido caused by relationship issues or physical health problems.
• Flibanserin was once controversial due to debates over its effectiveness.
• It is not suitable for women taking certain antidepressants due to drug interactions.
• The medication has warnings for severe hypotension and syncope.
• Patients are advised to avoid alcohol consumption completely while on the drug.
• Flibanserin's approval was considered a breakthrough for female sexual health.
• Insurance coverage for flibanserin varies and can be limited.
• The drug's marketing emphasizes the importance of patient counseling.

Be sure to read this information carefully each time.

Black Box Warnings .

It increases sexual desire and reduces related distress. Take it by mouth, as directed, and avoid grapefruit juice. Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services. Talk to your care team delayed ejaculation pills about the use of this medication in children.

It is not approved for use in children.

Proper use of flibanserin

Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study. 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 survey of women living with low sexual desire.

Common Adverse Effects

Continued efficacy and safety of flibanserin in premenopausal women with hypoactive sexual desire disorder (HSDD): Results from a randomized withdrawal trial. 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.

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Use of ADDYI and alcohol together close in time increases the risk of ed tablets 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, 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. Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

Warnings & Precautions

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.

Ask her, and start the conversation.

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.

What are some things I need to know or do while I take this drug?

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. NOTE: This medicine is only for you. Do not share this medicine with others. If you miss your dose at bedtime, skip the missed dose and take the next dose at bedtime the next day. Do not take this medication the next morning or double your next dose.

• Summary: A daily, non-hormonal pill for premenopausal women with HSDD.
• Key benefit: Modest increase in sexual desire and satisfying events for some.
• Key risk: Potentially severe interactions with alcohol and many medications.
• Management: Strict adherence to REMS, bedtime dosing, and no alcohol.
• Patient profile: Premenopausal woman with distress from low desire, otherwise healthy.
• Provider role: Certify, counsel, monitor, and manage expectations.
• Place in therapy: One option among a comprehensive approach to sexual health.
• Public health impact: Highlighted need for and challenges in female sexual medicine.
• Future: Continued evaluation of real-world outcomes and safety profile.

Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use.

In case of emergency/overdose

FLIBANSERIN (fly BAN ser in) treats hypoactive sexual desire disorder (HSDD). It works by balancing substances in the brain that help regulate mood and increase sex drive. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. They need to know if you have any of these conditions: History of depression or other mental health conditions An unusual or allergic reaction to flibanserin, other medications, foods, dyes, or preservatives Take this medication by mouth with water. Take it as directed on the prescription label. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine. Visit your care team for regular checks on your progress.

Tell your care team if your symptoms do not start to get better after you have taken this medication for 8 weeks.

Why is this medication prescribed?

Seeing my patients feel like themselves again has been incredibly rewarding.” “Addyi has impacted the way we approach women’s sexual health. Seeing my patients feel like themselves again has been incredibly rewarding.” 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.

Elderly Precautions

“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!” “Addyi has been an invaluable addition to my toolbox, becoming a crucial component in the comprehensive care of my female patients experiencing stress due to low libido.” “I used to dread going to bed with my husband, because I was never in the mood… he thought it was his fault. * Based on IQVIA data as of November 2024 * Based on IQVIA data as of November 2024 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.

Pharmacogenetic associations and support therapeutic management recommendations

Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder. 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. Do not drive, use machinery, or do anything that needs mental alertness for at least 6 hours after your dose and until you know how this medication affects you. Do not stand up or sit up quickly.

Take-Home Points

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. 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 sex power tablet of ADDYI not recommended, flibanserin concentrations substantially reduced Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity.

Brand Names: Canada

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. Acquired HSDD refers to HSDD that develops in a patient who previously had no problem with sexual desire. ADDYI is not indicated for use in men. Flibanserin is a medication that treats hypoactive sexual desire disorder, which causes low libido or a lack of sexual desire. This reduces the risk of dizzy or fainting spells. Alcohol can increase dizziness and drowsiness, and can increase the risk of low blood pressure or fainting spells when combined with this medication.