FDA Approval of Flibanserin — Treating Hypoactive Sexual Desire Disorder

Other > flibanserin


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.

Addyi is the #1 Prescribed Treatment by doctors for HSDD.1

"Advisers To FDA Recommend Agency Approve Drug To Boost Female Libido". Archived from the original on 4 June 2015. ^ "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".

Pediatric Precautions

Archived from the original on 13 February 2021. Archived from the original on 7 April 2021. Approves Addyi, a Libido Pill for Women". Archived from the original on 26 March 2021. Archived from the original on 18 November 2015.

What is this drug used for?

Archived from the original on 6 November 2015. "Raleigh's Sprout Pharmaceuticals awaits FDA ruling on female libido drug". 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. 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 blue sex pills directed by your doctor.

Point Explanation
Take at bedtime To reduce dizziness and fatigue
Avoid alcohol Increases risk of hypotension and sedation
Report side effects early Especially severe dizziness, fainting, or allergic reactions

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.

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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.

Information & Authors

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 other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Approval Year

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.

Interactions with Medicines

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. 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. 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.

Flibanserin as a Multifunctional Serotonin Agonist and Antagonist (MSAA): Modulator of Reward in Macrocircuits

"Evaluation of Flibanserin: Science and Advocacy at the FDA". ^ "Valeant - Valeant Pharmaceuticals to Acquire Sprout Pharmaceuticals". Archived from the original on 22 August 2015. Archived from the original on 17 November 2015. Archived from the original on 29 blue tablets January 2021.

Label Warnings

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). "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".

Activity profile

"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. 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. 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.

  • 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.

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.

Take-Home Points

(Ed). "Acute and repeated flibanserin administration in female rats modulates monoamines differentially across brain areas: a microdialysis study". "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.

IN CLINICAL TRIALS1, WOMEN ON ADDYI EXPERIENCED:

^ "Drug for sexual desire disorder opposed by panel". Archived from the original on 11 February 2021. ^ 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.

hepatic dosing

^ "Sprout Pharmaceuticals resubmits flibanserin NDA for treating HSDD in pre-menopausal women". Archived from the original on 19 March 2025. 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. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

Peds Dosing .

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 erection tablets 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. 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. If you have taken flibanserin at bedtime, do not drink alcohol until the following day. This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert).

  • Flibanserin was one of the first drugs approved specifically for female hypoactive sexual desire.
  • The drug's mechanism is different from that of PDE5 inhibitors used in men.
  • It can induce side effects like low blood pressure and syncope, requiring caution.
  • Patients should be monitored regularly for adverse effects during therapy.
  • Flibanserin's approval marked significant progress in women's sexual health.
  • It should be used with caution in women on other serotonergic medications.
  • The medication's safety profile is still under ongoing research.
  • It is not indicated for women with a history of alcohol abuse.
  • The benefits of flibanserin are generally seen as modest but meaningful for some women.

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. This medicine may cause you to feel dizzy, drowsy, or lightheaded. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert for at least 6 hours after you take this medicine and until you know how this medicine affects you. If you feel lightheaded, getting up slowing after sitting or lying down may help.