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.

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After taking flibanserin, do not drink any alcohol until the next day. 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.

Interaction with Alcohol

To help you remember, take it at the same time each day. 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. 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.

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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.

Adverse Effects

Ask your pharmacist about using those products safely. Store at room temperature away from light and moisture. Keep all medications away from children and pets. 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. 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.

  • Flibanserin is classified as a centrally acting serotonergic agent.
  • It is not a testosterone-based therapy, unlike some other treatments.
  • The FDA approval was based on studies showing increased sexual desire in women.
  • The medication can cause sleep disturbances, including somnolence.
  • Flibanserin has a potential for drug interactions with CYP3A4 inhibitors.
  • It is recommended to start treatment at least 4 weeks before expecting improvement.
  • Discontinuation of the drug normally leads to the loss of effects.
  • The drug's efficacy is modest compared to some male sexual dysfunction drugs.
  • Initiation of therapy involves screening for contraindications.

Treatment of HSDD and female sexual arousal disorder can be challenging.

  • The prescribing guidelines emphasize cautious use in women on other psychotropic drugs.
  • Flibanserin's approval was driven by a need for female-specific sexual health medications.
  • Its mechanism involves serotonergic pathways impacting sexual response.
  • The drug is typically part of a broader therapy including counseling or therapy.
  • Studies indicate a small but statistically significant benefit for some women.
  • It is important to rule out other medical or psychological causes before use.
  • Flibanserin is contraindicated with certain medications, such as CYP3A4 inhibitors.
  • Side effect management includes monitoring blood pressure and mental status.
  • The medication's role is to improve quality of life by addressing sexual desire challenges.

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.

In case of emergency/overdose

Female Hypoactive Sexual Desire Disorder: A Practical Guide to Causes, Clinical Diagnosis, and Treatment. 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.

Dosage forms and strengths (USA)

Flibanserin is not used to enhance sexual performance. 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. 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.

Interaction Partner Effect Advice
Alcohol Increased sedation and hypotension Avoid concurrent use
CYP3A4 inhibitors Elevated flibanserin levels Dose adjustment or avoid
Other serotonergic agents Increased risk of serotonin syndrome Avoid concomitant use

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.

Further reading

Disclosure: Preeti Patel declares no relevant financial relationships with ineligible companies. 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.

Other Medical Problems

Clinically Meaningful Benefit in Women with Hypoactive Sexual Desire Disorder Treated with Flibanserin. 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. Women with liver problems should not take flibanserin.

  • Flibanserin was developed by Boehringer Ingelheim, later licensed to Sprout Pharmaceuticals.
  • It is considered a "female Viagra," though its mechanism differs from male erectile drugs.
  • The medication is part of the growing field of female sexual dysfunction treatment.
  • Most clinical trials showed a modest increase in satisfying sexual events.
  • Flibanserin should be taken consistently for best results.
  • It is not recommended for women who are pregnant or breastfeeding.
  • Common adverse reactions include dry mouth and insomnia.
  • The drug was approved after extensive clinical trials involving thousands of women.
  • Long-term safety data is still being collected.

Because of these potentially serious side effects associated with alcohol use, not all doctors or pharmacies will be able to prescribe or dispense flibanserin. 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. To find this and previous JAMA Patient Pages, go to the Patient Page link on JAMA’s website at Spanish translations are available in the supplemental content tab.

  • 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.

Flibanserin may cause very low blood pressure resulting in dizziness, lightheadedness, and fainting. Tell your doctor if you have or have ever had low blood pressure or any condition that can cause low blood pressure or if you drink or have ever drunk large amounts of alcohol.

Are there OTHER USES for this medicine?

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 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). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Drinking alcohol around the same time as taking flibanserin can increase the risk of having very low blood pressure.

Availability and cost

Warning: Breastfeeding is not recommended while using this drug. 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.

Advocacy groups

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. 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. Wait at least 2 hours after drinking 1 or 2 alcoholic drinks before taking flibanserin at bedtime. If you drink 3 or more alcoholic drinks in the evening, skip your flibanserin dose on that evening. After taking flibanserin at bedtime, do not drink any alcohol until the next day. If you have any of the following symptoms, call your doctor immediately and lie down: lightheadedness, fainting, or dizziness. Tell your doctor if you have or have ever had liver disease. Your doctor will probably tell you not to take flibanserin. Some medications should not be taken with flibanserin.

Warnings & Precautions

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. CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the blue sex pills expertise and judgment of your healthcare professional.