FDA approves expanded use of flibanserin for hypoactive sexual desire disorder in women

Other > flibanserin


Alcohol and marijuana may intensify this effect. Use care when operating a vehicle, vessel (e.g., boat), or machinery. If you drink alcohol, discuss the safe use of alcohol while using this medication with your healthcare professional. Do not eat grapefruit or drink grapefruit juice at any time while taking this medication. See also Warning and How to Use sections. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.

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

Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Other medications can affect the removal of flibanserin from your body, which may affect how flibanserin works. Examples include azole antifungals (such as fluconazole, ketoconazole), certain calcium channel blockers (such as diltiazem, verapamil), macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others. Tell your doctor or pharmacist cost of vardenafil if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

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

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness.

How it works

Tell your doctor if your condition does not get better after 8 weeks of treatment. If you miss a dose, skip the missed dose. Take your next dose at bedtime the next day. Do not double the dose to catch up. Warning: Breastfeeding is not recommended while using this drug. Ask your pharmacist about using those products safely. Store at room temperature away from light and moisture.

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Keep all medications away from children and pets.

  • Global availability varies; approved in the US, Canada, and some other countries.
  • Not approved in the European Union by the EMA as of current knowledge.
  • Different brand names may be used in countries where it is marketed.
  • Importing for personal use from other countries carries risks and is often illegal.
  • Counterfeit versions of the medication are a potential danger.
  • Patients should only obtain it from a certified, licensed pharmacy.
  • Telemedicine may be used for consultations but REMS requirements still apply.
  • The future of flibanserin may involve generic competition reducing cost.
  • Research into its potential effects on other conditions (e.g., depression) is limited.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Ask a clinical question and tap into Healio AI's knowledge base. Healio's exclusive daily news coverage of clinical data Selected from data included with permission and copyrighted by FDB, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution in professional health care settings.

if she’s saying these things, it may be hsdd

Disclosure: Karen Carlson declares no relevant financial relationships with ineligible companies. Review New developments in the treatment of hypoactive sexual desire disorder - a focus on Flibanserin. 2017]Review New developments in the treatment of hypoactive sexual desire disorder - a focus on Flibanserin.Jayne CJ, Heard MJ, Zubair S, Johnson DL. 2020]Review Evaluation of safety for flibanserin.Clayton AH, Brown L, Kim NN. Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin.

Elderly Precautions

2022]Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin.Simon JA, Clayton AH, Kim NN, Patel S. Sex Med. Review Flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women. 2015]Review Flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.Dhanuka I, Simon JA. Female Hypoactive Sexual Desire Disorder: A Practical Guide to Causes, Clinical Diagnosis, and Treatment.

General drug facts

2020]Female Hypoactive Sexual Desire Disorder: A Practical Guide to Causes, Clinical Diagnosis, and Treatment.Kingsberg SA, Simon JA. This medication is used to treat women who have not gone through menopause who have low sexual desire and are concerned about it. Flibanserin should not be used to treat low sexual desire caused by: a medical or mental/mood disorder, problems in the relationship, or the effects of other drugs. This medication should not be used by women who have gone through menopause, or by men. Flibanserin is not used to enhance sexual performance. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of your healthcare professional. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you. You should consult your healthcare professional before taking any drug, changing your diet or commencing or discontinuing any course of treatment. This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment. Low sexual desire (libido) is a common type of sexual dysfunction in women and can be challenging to treat. Sexual dysfunction can refer to difficulties in libido (sex drive), arousal, or orgasm. There are many causes of sexual dysfunction. Psychiatric conditions such as depression or anxiety or emotional distress from work or relationship stressors are common causes. Some medical conditions can also affect sexual function, such as heart disease, certain neurological conditions, arthritis, or hormone changes during menopause. Medications, especially antidepressants, can also cause sexual dysfunction. Addressing the underlying medical or psychological issues improves sexual function in most women. However, some women who have no other medical or psychological concerns still have low sexual desire that affects both their personal and relationship well-being. This condition is referred to as female sexual interest/arousal disorder. This is a new diagnosis in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition), which combined the previously separate disorders of hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder. The prevalence of these disorders varies widely depending on the population surveyed, but studies have suggested it can range anywhere from 5% to 15% of women.

Overdose/Missed Dose

National Institute of Diabetes and Digestive and Kidney Diseases; Bethesda (MD): Jan 26, 2018. Female sexual dysfunction: a focus on flibanserin. Gelman F, Atrio J. Flibanserin for hypoactive sexual desire disorder: place in therapy. Holt H, Tingen J.

Missed Dose

Flibanserin (Addyi) for Hypoactive Sexual Desire Disorder in Premenopausal Women. Flibanserin Efficacy and Safety in Premenopausal Women With Generalized Acquired Hypoactive Sexual Desire Disorder. Flibanserin for Treating Hypoactive Sexual Desire Disorder. Clayton AH, Croft HA, Yuan J, Brown L, Kissling R. Safety of Flibanserin in Women Treated With Antidepressants: A Randomized, Placebo-Controlled Study.

Incidence not known

Accidental Flibanserin Ingestion in Children Causing Acute Respiratory and Central Nervous System Depression: What Health Care Professionals Need to Know. Next-day residual effects of flibanserin on simulated driving performance in premenopausal women. 2017 Jul;32(4) [PMC free article: PMC5697607] [PubMed: 28568608] Abstracts from the 2017 American College of Medical Toxicology (ACMT) Annual Scientific Meeting. Disclosure: China Pierrelus declares no relevant financial relationships with ineligible companies. Disclosure: Preeti Patel declares no relevant financial relationships with ineligible companies. Treatment of HSDD and female sexual arousal disorder can be challenging.

  • Clinical trials excluded women with many comorbidities (e.g., unstable medical conditions).
  • Real-world effectiveness in broader populations may differ from trial results.
  • Patient satisfaction with treatment can vary widely.
  • Some women report significant improvement in sexual desire and distress.
  • Others discontinue due to side effects or lack of meaningful benefit.
  • Adherence to daily dosing is a challenge for some patients.
  • The bedtime dosing schedule is intended to mitigate side effects like dizziness.
  • Taking it with a high-fat meal can increase absorption and side effect risk.
  • Should be taken on an empty stomach, at least 2 hours after a high-fat meal.

In August 2015, the US Food and Drug Administration (FDA) approved a medication called flibanserin to treat HSDD in premenopausal women, making it the first FDA-approved medication for low sexual desire in women. It is anticipated to be available in the United States in October 2015. Flibanserin works by interacting with certain receptors for serotonin, a neurotransmitter that has a role in regulating mood, sleep, digestion, and many other functions of the body. The exact way in which flibanserin leads to improved sexual desire in women is not clear, but studies have shown that it has a beneficial effect in women diagnosed as having HSDD. Flibanserin can have serious side effects, including low blood pressure and fainting. The risk of these side effects increases with alcohol use, so alcohol absolutely cannot be combined with flibanserin. Other medications including some birth control pills and antifungal agents can also increase the risk of these side effects. Women with liver problems should not take flibanserin. Because of these potentially serious side effects associated with alcohol use, not all doctors or pharmacies will be able to prescribe or dispense flibanserin.

Addyi (flibanserin) dosage

100 mg Brand(s): Addyi(R), Sprout film-coated Read the Medication Guide provided by your pharmacist before you start taking flibanserin and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily at bedtime. Take flibanserin only at bedtime to reduce your risk of low blood pressure, fainting, and drowsiness while you are awake. After taking flibanserin, do not drink any alcohol until the next day.

Pediatric Precautions

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Because flibanserin is a new medication, continued postmarketing data collected by the FDA will be important. In the meantime, the FDA encourages the development of new drugs to treat female sexual disorders given the continued need for effective treatments.

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