FDA approves flibanserin for hypoactive sexual desire disorder in postmenopausal women
Women who have gone through menopause and men should not use flibanserin.
Are there OTHER USES for this medicine?
^ "Critics: Women's Sex Pill Approval Vote Driven By PR, Not Science". Archived from the original on 4 March 2021. "First drug to improve sexual desire in women approved in the United States". Archived from the original on 13 February 2021. Archived from the original on 7 April 2021.
Consumer Information Use and Disclaimer
Approves Addyi, a Libido Pill for Women". Archived from the original on 26 March 2021. Archived from the original on 18 November 2015. Archived from the original on 6 November 2015. "Raleigh's Sprout Pharmaceuticals awaits FDA ruling on female libido drug". Do not use this medicine to improve sexual performance.
| Product | Dosage | Quantity + Bonus | Price | |
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| Levitra Professional | 20mg | 60 + 2 Pills | 223.11€ 212.49€ | |
| Viagra Super Active | 100mg | 30 + 6 Pills | 64.09€ 61.04€ | |
| Kamagra Gold | 50 mg | 32 Pills | 103.06€ 98.15€ | |
| Cialis Original | 20mg | 4 Pills | 41.99€ 39.99€ | |
| Kamagra Soft Tabs | 100 mg | 20 Pills | 79.79€ 75.99€ | |
| Levitra Generic | 10mg | 60 + 6 Pills | 112.98€ 107.60€ | |
| Cialis Original | 20mg | 76 + 4 Pills | 319.19€ 303.99€ | |
| Viagra Generic | 100mg | 90 + 6 Pills | 129.02€ 122.88€ | |
| Levitra Generic | 40mg | 20 Pills | 67.56€ 64.34€ | |
| Levitra Generic | 40mg | 360 + 10 Pills | 704.99€ 671.42€ | |
| Kamagra | 100mg | 120 + 6 Pills | 330.74€ 314.99€ | |
| Viagra Generic | 50mg | 360 + 10 Pills | 225.33€ 214.60€ | |
| Levitra Original | 20mg | 8 Pills | 65.05€ 61.95€ | |
| Levitra Soft Tabs | 20mg | 120 + 8 Pills | 288.52€ 274.78€ | |
| Kamagra Gold | 100 mg | 84 + 6 Pills | 264.44€ 251.85€ | |
| Levitra Generic | 60mg | 20 Pills | 81.30€ 77.43€ | |
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This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any pills for womens libido other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Flibanserin should never be used in children for HSDD. Flibanserin is not recommended for use in the elderly. Safety and efficacy have not been established. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur.
What is Addyi (flibanserin)?
"Flibanserin (Addyi): The First FDA-Approved Treatment for Female Sexual Interest/Arousal Disorder in Premenopausal Women". Stahl's Essential Psychopharmacology: Neuroscientific Basis and Practical Applications. The dual control model: The role of sexual inhibition & excitation in sexual arousal and behavior In Janssen, E. (Ed). "Acute and repeated flibanserin administration in female rats modulates monoamines differentially across brain areas: a microdialysis study".
Oral Administration
"Anti-anhedonic actions of the novel serotonergic agent flibanserin, a potential rapidly-acting antidepressant". ^ "18 June 2010 meeting of the FDA Advisory Committee for Reproductive Health Drugs" (PDF). Archived from the original (PDF) on 13 September 2016. ^ "Drug for sexual desire disorder opposed by panel". Archived from the original on 11 February 2021. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended.
- 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.
Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur.
What should I do if I forget a dose?
"Region-dependent effects of flibanserin and buspirone on adenylyl cyclase activity in the human brain". "Flibanserin has anxiolytic effects without locomotor side effects in the infant rat ultrasonic vocalization model of anxiety". "The Company Behind 'Female Viagra' Just Raised $20 Million in Funding". "The Women's Libido Pill Is Back, and So Is the Controversy". Flibanserin is used to treat hypoactive sexual desire disorder (HSDD) in women younger than 65 years of age who have low sexual desire that is troubling to them and is not caused by a medical or mental problem, problems in the relationship, or medicine or other drug use. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Using this medicine with any of the following is not recommended.
| Issue | Description |
|---|---|
| Efficacy Debate | Some experts question the clinical significance of benefits |
| Side Effect Concerns | Risks of hypotension, syncope, and severe allergic reactions |
| Marketing & Approval Controversies | Criticism over FDA approval process and marketing practices |
| Post-Marketing Surveillance | Ongoing monitoring for rare adverse events |
Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco. Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Depression or mental illness, history of or Drug or alcohol use disorder, or history of or Hypotension (low blood pressure)—Use with caution. Liver problem—Should not be used in patients with this condition. Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. The medicine should come with a Medication Guide. Ask your doctor or pharmacist if you have any questions. Taking this medicine at a time other than bedtime may increase risk of low blood pressure, fainting, accidental injury, or sleepiness. Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Dosing & Uses
^ a b "Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee" (PDF). Archived from the original (PDF) on 5 June 2015. Archived from the original on 15 October 2010. ^ "Sprout Pharmaceuticals resubmits flibanserin NDA for treating HSDD in pre-menopausal women". Archived from the original on 19 March 2025.
Black Box Warnings
Archived from the original on 10 August 2015. ^ FDA seeks more tests on a female Viagra, by Matthew Perrone, The Detroit Free Press, page 2A Wednesday, 12 February 2014 "FDA: Female sex drive drug needs more research - CNN.com". Archived from the original on 1 August 2017. "Advisers To FDA Recommend Agency Approve Drug To Boost Female Libido". Archived from the original on 4 June 2015. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For oral dosage form (tablets):For treatment of hypoactive sexual desire disorder:Adults—100 milligrams (mg) once a day at bedtime.Children—Use is not recommended. For treatment of hypoactive sexual desire disorder:Adults—100 milligrams (mg) once a day at bedtime.Children—Use is not recommended. Adults—100 milligrams (mg) once a day at bedtime. For treatment of hypoactive sexual desire disorder: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects. Using these medicines together may increase risk for low blood pressure and fainting. Lightheadedness, dizziness, or fainting may occur when you take flibanserin within 2 hours of drinking alcohol.
- In 2019, the FDA required updates to the prescribing information regarding liver injury.
- Cases of hepatitis and liver enzyme elevations were reported post-marketing.
- Patients should be monitored for symptoms of liver injury (jaundice, dark urine).
- Discontinue flibanserin if liver injury is suspected.
- The REMS was modified to strengthen the warning about hepatotoxicity.
- Patients with signs of liver disease should not start flibanserin.
- Baseline liver enzyme testing is now considered a standard part of patient assessment.
- Follow-up testing may be recommended based on clinical judgment.
- The overall incidence of serious liver injury appears to be low.
It is recommended to wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks (eg, one 12-ounce regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits or shot) before taking flibanserin at bedtime, or you may skip your dose if you drink 3 or more standard alcoholic drinks in the evening. If you have taken flibanserin at bedtime, do not drink alcohol until the following day.
- Patients should consult healthcare providers for proper assessment before starting flibanserin.
- Its regulatory approval has sparked ongoing debate about female sexual dysfunction treatments.
- Flibanserin is not a hormone and does not affect estrogen or testosterone.
- Pharmacovigilance continues to monitor long-term safety and rare adverse effects.
- The medication is priced variably, impacting access for some patients.
- Women are advised not to drink alcohol, as it increases side effect risks.
- Flibanserin's moderate efficacy underscores the importance of realistic expectations.
- The goal is to enhance women’s sexual desire and overall satisfaction.
- Continuous research aims to develop more effective and safer female sexual health drugs.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert).
dopamine, norepinephrine, and serotonin3
Archived from the original on 3 June 2019. "'Faux-advocacy,' not science, prompted FDA panel's OK of 'low libido' drug for women, critics charge". Archived from the original on 30 August 2015. "Evaluation of Flibanserin: Science and Advocacy at the FDA". ^ "Valeant - Valeant Pharmaceuticals to Acquire Sprout Pharmaceuticals".
Administration Notes
Archived from the original on 22 August 2015. Archived from the original on 17 November 2015. Archived from the original on 29 January 2021. Archived from the original on 26 October 2020. Sex, aggression and pair-bond: a study on the serotonergic regulation of female sexual function in the marmoset monkey (Thesis). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using flibanserin. If your condition does not improve within 8 weeks, or if it become worse, check with your doctor.
