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

Other > flibanserin


istradefyllineistradefylline will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

  • Flibanserin, a serotonin receptor modulator, was initially investigated for depression.
  • Its approval marked a historic moment in treating female sexual dysfunction.
  • The medication's side effects necessitate careful patient education.
  • Efficacy is often supported by patient-reported improvements in desire.
  • It does not function as an aphrodisiac but affects brain chemistry.
  • Flibanserin therapy requires adherence to dosing instructions.
  • Women with low libido due to other health issues may not benefit from it.
  • Its role is to complement behavioral or psychological therapy if needed.
  • Research continues into better options for treating female hypoactive sexual desire.

Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates. istradefylline will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lansoprazolelansoprazole will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lansoprazole will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. larotrectiniblarotrectinib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. larotrectinib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Either increases effects of the other by sedation. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.

  • 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.

lenvatiniblenvatinib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lenvatinib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lomitapideflibanserin increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Reduce lomitapide dose if coadministered with weak CYP3A4 inhibitors (see Dosage Modifications in drug monograph).

  • Reporting of adverse events is encouraged through the FDA MedWatch program.
  • Healthcare providers should report syncope, severe hypotension, or liver injury.
  • Post-marketing surveillance is critical for understanding rare, long-term risks.
  • Drug utilization reviews track prescribing patterns and potential misuse.
  • In case of suspected pregnancy, patients should contact their doctor immediately.
  • Animal studies showed developmental toxicity at doses much higher than human dose.
  • Lactation studies in animals showed excretion in milk; human data are lacking.
  • Decision to breastfeed while on flibanserin requires weighing potential risks.
  • The benefit for an individual patient must justify the potential risk to a fetus/infant.

flibanserin increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

In case of emergency/overdose

fentanyl intranasal and flibanserin both increase sedation. fentanyl transdermalfentanyl transdermal and flibanserin both increase sedation. fentanyl transdermal and flibanserin both increase sedation. fentanyl transmucosalfentanyl transmucosal and flibanserin both increase sedation. fentanyl transmucosal and flibanserin both increase sedation.

Storage Class

fexinidazolefexinidazole will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. fexinidazole will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. fluconazolefluconazole will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. fluconazole will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. fluoxetinefluoxetine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lomustinelomustine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lomustine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. losartanlosartan will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. losartan will increase the level or effect of flibanserin by affecting super p force online hepatic/intestinal enzyme CYP3A4 metabolism. lovastatinlovastatin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lovastatin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

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lumacaftor/ivacaftorlumacaftor/ivacaftor will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lumacaftor/ivacaftor will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lurasidonelurasidone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.flibanserin, lurasidone.

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

lurasidone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mavorixaforflibanserin will increase the level or effect of mavorixafor by P-glycoprotein (MDR1) efflux transporter.

Proper Use

fedratinibfedratinib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Adjust dose of drugs that are CYP3A4 substrates as necessary.fedratinib will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. Adjust dose of drugs that are CYP2C19 substrates as necessary. fedratinib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Adjust dose of drugs that are CYP3A4 substrates as necessary.

Quality Segment

felodipinefelodipine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. felodipine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration with drugs that increase serotoninergic effects may increase the risk of serotonin syndrome. Risk for sedation increased if flibanserin is coadministration with other CNS depressants.fentanyl will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. fentanyl intranasalfentanyl intranasal and flibanserin both increase sedation. Monitor mavorixafor if coadministered with P-gp inhibitors and reduce mavorixafor dose if needed. flibanserin will increase the level or effect of mavorixafor by P-glycoprotein (MDR1) efflux transporter. mefloquinemefloquine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mefloquine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mestranolmestranol will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

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

mestranol will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Risk for sedation increased if flibanserin is coadministration with other CNS depressants.methadone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. methimazolemethimazole will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. methimazole will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

it’s harder for me to become aroused

ginkgo bilobaginkgo biloba will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ginkgo biloba will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. flibanserin will increase the level or effect of glecaprevir/pibrentasvir by P-glycoprotein (MDR1) efflux transporter. glyburideglyburide will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. glyburide will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Related treatment guides

hydralazinehydralazine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. hydralazine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ifosfamideifosfamide will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ifosfamide will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. irbesartanirbesartan will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. methoxsalenmethoxsalen will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

What SIDE EFFECTS can this medicine cause?

irbesartan will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. isoniazidisoniazid will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. isoniazid will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. isradipineisradipine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. isradipine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. methoxsalen will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. methylprednisolone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. micafunginmicafungin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

What other information should I know?

fluoxetine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. fluvastatinfluvastatin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. fluvastatin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. fluvoxaminefluvoxamine will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. May increase risk of hypotension, syncope, and CNS depression fosphenytoinfosphenytoin will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.

Brand Names: Canada

fosphenytoin will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. gabapentin enacarbilgabapentin enacarbil and flibanserin both increase sedation. gabapentin lovegra 100 mg enacarbil and flibanserin both increase sedation. gemfibrozilgemfibrozil will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. gemfibrozil will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism.