US Food and Drug Administration Approval of Addyi (Flibanserin) for Treatment of Hypoactive Sexual Desire Disorder
nitrous oxide and flibanserin both increase sedation.
I feel stressed due to my low desire
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. micafungin 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.midazolam will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.
generalized hypoactive sexual desire disorder, acquired
mifepristonemifepristone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mifepristone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mirtazapinemirtazapine will increase the vigora spray level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mirtazapine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mitapivatmitapivat decreases levels of flibanserin by affecting hepatic enzyme CYP2C19 metabolism.
Dosage forms and strengths (USA)
Monitor patients for loss of therapeutic effect if taking sensitive CYP2C19 substrates. mitapivat decreases levels of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. mitotanemitotane will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mitotane will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mitoxantronemitoxantrone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nizatidinenizatidine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nizatidine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. olanzapineolanzapine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Soft Tabs | 20mg | 60 + 4 Pills | 178.40€ 169.90€ | |
| Viagra Generic | 200mg | 90 + 6 Pills | 170.79€ 162.66€ | |
| Viagra Oral Jelly | 100mg | 110 + 9 Sachets | 284.63€ 271.08€ | |
| Cialis Generic | 40mg | 20 Pills | 59.47€ 56.64€ | |
| Viagra Super Active | 100mg | 20 + 4 Pills | 48.05€ 45.76€ | |
| Viagra Original | 100mg | 8 Pills | 59.84€ 56.99€ | |
| Cialis Super Active | 20mg | 30 + 6 Pills | 128.09€ 121.99€ | |
| Viagra Original | 100mg | 64 + 4 Pills | 264.15€ 251.57€ | |
| Kamagra Gold | 100 mg | 12 Pills | 55.64€ 52.99€ | |
| Kamagra Soft Tabs | 100mg | 20 Pills | 79.79€ 75.99€ | |
| Viagra Generic | 50mg | 120 + 6 Pills | 129.64€ 123.47€ | |
| Levitra Generic | 20mg | 180 + 10 Pills | 293.10€ 279.14€ | |
| Levitra Original | 20mg | 4 Pills | 45.87€ 43.69€ | |
| Cialis Professional | 40mg | 180 + 4 Pills | 618.23€ 588.79€ | |
| Viagra Soft Tabs | 100mg | 270 + 10 Pills | 419.95€ 399.95€ | |
| Levitra Generic | 10mg | 60 + 6 Pills | 112.98€ 107.60€ |
Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.flibanserin, olanzapine. olanzapine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
- 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.
omeprazoleomeprazole will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism.
Frequently asked questions
mitoxantrone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. modafinilmodafinil will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. modafinil will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. nafcillinnafcillin will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nafcillin will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Other Interactions
naldemedineflibanserin increases levels of naldemedine by P-glycoprotein (MDR1) efflux transporter. Monitor naldemedine for potential adverse effects if coadministered with P-gp inhibitors. flibanserin increases levels of naldemedine by P-glycoprotein (MDR1) efflux transporter. nevirapinenevirapine will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nevirapine will decrease the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Common Adverse Effects
nifedipinenifedipine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nifedipine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nisoldipinenisoldipine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nisoldipine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nitrous oxidenitrous oxide and flibanserin both increase sedation. Coadministration of flibanserin with strong CYP2C19 inhibitors may increase flibanserin exposure and increase the risk of hypotension, syncope, and CNS depression.omeprazole will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. omeprazole will increase the level or effect of flibanserin by affecting hepatic enzyme CYP2C19 metabolism. orphenadrineorphenadrine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
| 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 |
orphenadrine 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.
oxybutyninoxybutynin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. oxybutynin will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
What should I do if I forget a dose?
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. 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. Monitor mavorixafor if coadministered with P-gp inhibitors and reduce mavorixafor dose if needed.
Pregnancy Precautions
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. mestranol will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
What do I do if I miss a dose?
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. methoxsalenmethoxsalen 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. oxybutynin transdermal will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
What should I do in case of OVERDOSE?
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. 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.
What are some side effects that I need to call my doctor about right away?
Reduce lomitapide dose if coadministered with weak CYP3A4 inhibitors (see Dosage Modifications in drug monograph). flibanserin increases levels of lomitapide 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.
A note about sex and gender
losartan will increase the level or effect of flibanserin by affecting 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. 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. palbociclibpalbociclib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
| Country | Approval Status | Year |
|---|---|---|
| United States | Approved | 2015 |
| Canada | Approved | 2016 |
| European Union | Pending/Under review | N/A |
| Australia | Not approved | N/A |
palbociclib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. paroxetineparoxetine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. paroxetine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. pazopanibpazopanib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. pazopanib will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. pentamidinepentamidine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. pentamidine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
- Patients should consult healthcare providers for proper assessment before starting flibanserin.
- Its regulatory approval has sparked ongoing debate about female sexual dysfunction treatments.
- Flibanserin is not a hormone and does not affect estrogen or testosterone.
- Pharmacovigilance continues to monitor long-term safety and rare adverse effects.
- The medication is priced variably, impacting access for some patients.
- Women are advised not to drink alcohol, as it increases side effect risks.
- Flibanserin's moderate efficacy underscores the importance of realistic expectations.
- The goal is to enhance women’s sexual desire and overall satisfaction.
- Continuous research aims to develop more effective and safer female sexual health drugs.