US Food and Drug Administration Approval of Addyi (Flibanserin) for Treatment of Hypoactive Sexual Desire Disorder

Other > flibanserin


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 other types of allergies, such as to foods, dyes, preservatives, or animals.

  • Flibanserin acts as an agonist on dopamine receptors and antagonist on certain serotonin receptors.
  • The medication can take several weeks to show benefits.
  • It is not approved for use in postmenopausal women.
  • Flibanserin was initially developed as an antidepressant.
  • It has a pharmacokinetic profile with a half-life of around 13 hours.
  • Dose adjustments are necessary for patients with liver impairment.
  • The drug can cause hypotension, especially with alcohol or CYP3A4 inhibitors.
  • Patients are monitored for side effects such as sleepiness and low blood pressure.
  • Flibanserin's efficacy is moderate and varies among women.

For non-prescription products, read the label or package ingredients carefully. Flibanserin should never be used in children for HSDD.

WHY is this medicine prescribed?

Women who have gone through menopause and men should not use flibanserin. Do not use this medicine to improve sexual performance. 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. 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 cheap lovegra tablets 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.

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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. 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.

Country Approval Status Year
United States Approved 2015
Canada Approved 2016
European Union Pending/Under review N/A
Australia Not approved N/A

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. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Using this medicine with any of the following is not recommended. 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.

i have little to no sexual desire

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.

Quality Segment

^ "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 blue sex pills in the United States". Archived from the original on 13 February 2021. Archived from the original on 7 April 2021. 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.

Metrics & Citations

"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.

Brand Names

^ 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. 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.

Society and culture

Archived from the original on 15 July 2017. "Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin". "In vivo electrophysiological assessment of the agonistic properties of flibanserin at pre- and postsynaptic 5-HT1A receptors in the rat brain". "Mechanism of action of flibanserin, a multifunctional serotonin agonist and antagonist (MSAA), in hypoactive sexual desire disorder". "Multifunctional pharmacology of flibanserin: possible mechanism of therapeutic action in hypoactive sexual desire disorder".

Key Takeaways

"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". Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Aspect Details
Chemical Formula C_20H_21F_3N_4O
Molecular Weight 370.41 g/mol
Key Functional Groups Triazole ring, fluorinated phenyl group
Structural Type Non-steroidal compound

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.

  • Direct comparison trials between flibanserin and bremelanotide are lacking.
  • Choice of treatment depends on patient preference, risk profile, and cost.
  • Psychological and interpersonal factors are important contributors to HSDD.
  • Combining medication with sex therapy or counseling may improve outcomes.
  • Flibanserin does not increase libido in individuals without HSDD.
  • It is not approved or intended for use as a recreational or enhancement drug.
  • Off-label use, such as in postmenopausal women or men, is not supported by evidence.
  • Healthcare providers must complete an online knowledge assessment for REMS certification.
  • Certification must be renewed periodically according to the REMS program.

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.

Related/similar drugs

"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. 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.

  • Flibanserin is used to treat premenopausal women with hypoactive sexual desire disorder (HSDD).
  • It is marketed under the brand name Addyi.
  • Flibanserin works by modulating serotonin and dopamine levels in the brain.
  • It was approved by the FDA in 2015 for HSDD treatment.
  • Common side effects include dizziness, nausea, and fatigue.
  • Flibanserin is usually taken once daily at bedtime.
  • It has contraindications with alcohol due to risk of severe hypotension.
  • Patients should avoid alcohol while using flibanserin.
  • It is a non-hormonal medication specifically for sexual desire issues.

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.

Adult Dosing .

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). Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Property Description Status
Approved Uses Hypoactive Sexual Desire Disorder (HSDD) in women Yes
Mechanism of Action Serotonin receptor modulator Partial agonist & antagonist
FDA Approval Year 2015
Common Brand Name Addyi

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. 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.

  • Flibanserin should be discontinued if no benefit is observed after several weeks.
  • The medication's influence on mental health conditions is still being studied.
  • Flibanserin was recognized as a breakthrough therapy for female sexual desire issues.
  • Its use is guided by strict medical protocols due to safety concerns.
  • Women are encouraged to report any adverse effects during treatment.
  • Continued research aims to improve treatment options for female sexual health.
  • Flibanserin is one of a few FDA-approved drugs for Female Sexual Desire Disorder.
  • Clinical improvements may include increased frequency of satisfying sexual events.
  • The drug's use should be combined with counseling when appropriate.

If you have taken flibanserin at bedtime, do not drink alcohol until the following day.

Helping Veterans stay well and well-informed

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".

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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". This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert).

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