FDA approves flibanserin for hypoactive sexual desire disorder in postmenopausal women
gemfibrozilgemfibrozil will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism.
- 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.
gemfibrozil will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism.
| Side Effect | Frequency | Severity |
|---|---|---|
| Dizziness | Common | Mild to Moderate |
| Nausea | Common | Mild |
| Fatigue | Moderate | Mild |
| Sleepiness | Moderate | Mild |
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.
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ergotamine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ethinylestradiolethinylestradiol will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ethinylestradiol will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. etoposideetoposide will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. etoposide will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
SMILES string
etravirineetravirine will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. etravirine will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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.
Quality Segment
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. 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. glyburideglyburide will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
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glyburide will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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.
Microcircuits and Sexual Interest and Desire
doxorubicin liposomal will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. duvelisibduvelisib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.flibanserin will increase the level or effect of duvelisib by P-glycoprotein (MDR1) efflux transporter. duvelisib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Key Takeaways
Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate. efavirenzefavirenz will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. efavirenz will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. elagolixelagolix will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. Caution with sensitive CYP2C19 substrates.elagolix decreases levels of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Comparison table
Consider increasing CYP3A substrate dose if needed. elagolix will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. enzalutamideenzalutamide will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. enzalutamide will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ergotamineergotamine 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.
- 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.
irbesartanirbesartan will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. irbesartan will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Black Box Warnings .
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. fentanyl intranasal and flibanserin both increase sedation. fentanyl transdermalfentanyl transdermal and flibanserin both increase sedation. fentanyl transdermal and male enhancement pill flibanserin both increase sedation.
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING and SPECIAL PRECAUTIONS sections, call your doctor immediately:
fentanyl transmucosalfentanyl transmucosal and flibanserin both increase sedation. fentanyl transmucosal and flibanserin both increase sedation. 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.
Related treatment guides
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. 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. isoniazidisoniazid will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism.
I feel stressed due to my low desire
Risk for sedation increased if flibanserin is coadministration with other CNS depressants.dexmedetomidine 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.diazepam will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. diazepam buccaldiazepam buccal and flibanserin both increase sedation. diazepam buccal and flibanserin both increase sedation. diazepam intranasaldiazepam intranasal and flibanserin both increase sedation.
What are some side effects that I need to call my doctor about right away?
diazepam intranasal and flibanserin both increase sedation. diclofenacdiclofenac will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. diclofenac will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. dihydroergotamine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. disulfiramdisulfiram will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Dosage Forms & Strengths
disulfiram will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. docetaxeldocetaxel will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. docetaxel will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. doxorubicindoxorubicin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. doxorubicin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. isoniazid will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism.
- The chemical name is 1,2,3,4-tetrahydro-1-{[2-(1,2,3,4-tetrahydro-8-quinolyl)ethyl]amino}methyl-6-fluorobenz[cd]indol-5(6H)-one.
- Molecular formula is C₂₀H₂₁F₃N₄O.
- It is a white to off-white powder that is slightly soluble in water.
- The tablet contains inactive ingredients: microcrystalline cellulose, croscarmellose sodium.
- Also contains magnesium stearate, hypromellose, titanium dioxide, and iron oxide red.
- Manufactured under strict Good Manufacturing Practice (GMP) standards.
- Distributed in bottles or blister packs, typically containing 30 tablets.
- National Drug Code (NDC) for Addyi 100 mg is 0187-XXXX-XX (varies by pack).
- Keep out of reach of children and pets.
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. istradefyllineistradefylline will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
- 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.
Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials.
| 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 |
This effect was not observed with istradefylline 20 mg/day.
Availability and cost
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. 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 enacarbil and flibanserin both increase sedation.
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