Flibanserin

Flibanserin, known as the "female Viagra", is a prescription medication used to enhance sexual desire and decrease emotional distress in premenopausal women with hypoactive sexual desire disorder (HSDD). HSDD is the most commonly reported sexual dysfunction in women. 

Although flibanserin has been called "the female Viagra", the way in which it works is distinctly different from Viagra. Viagra works by increasing blood flow to the genitals, whereas flibanserin may work more like an antidepressant by correcting an imbalance of neurotransmitters in the brain to help restore sexual desire. It has effects on dopamine, norepinephrine, and serotonin levels in the brain.

Flibanserin comes as a tablet and is typically taken daily, at bedtime. 

Common side effects of flibanserin include dizziness, nausea, and sleepiness. Flibanserin can also cause fainting, especially when used with alcohol.

Addyi, known as the "female Viagra", is a prescription medication used to enhance sexual desire and decrease emotional distress in premenopausal women with hypoactive sexual desire disorder (HSDD). 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Flibanserin may be found in some form under the following brand names:

• Addyi

Serious side effects have been reported with flibanserin. See the “Flibanserin Precautions” section.

Common side effects of flibanserin include the following:

• dizziness
• nausea
• tiredness
• difficulty falling asleep or staying asleep
• dry mouth

This is not a complete list of flibanserin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• certain medicines used to treat HIV-1 infection, such as amprenavir, atazanavir (REYATAZ), fosamprenavir (LEXIVA), ritonavir (NORVIR), saquinavir (INVIRASE), nelfinavir (VIRACEPT), and indinavir (CRIXIVAN)
• certain medicines that you take by mouth used to treat fungal infections, such as fluconazole (DIFLUCAN), ketoconazole, itraconazole (ONMEL, SPORANOX), and posaconazole (NOXAFIL)
• certain antibiotics, such as ciprofloxacin (CIPRO, CIPRO XR), erythromycin (ERY-TAB, ERYC ,PCE), telithromycin (KETEK), and clarithromycin (BIAXIN)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• medications that block a protein in the body (CYP2C19) such as Proton pump inhibitors [omeprazole (Prilosec) and esomeprazole (Nexium)], selective serotonin reuptake inhibitors [escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa)], and benzodiazepines [Alprazolam (Xanax) and Lorazepam (Ativan)]
• certain medicines used to treat Hepatitis C infection, such as boceprevir (VICTRELIS) and telaprevir
• certain medicines used to treat high blood pressure, chest pain (angina), or other heart problems, such as diltiazem (CARDIZEM,CARDIZEM CD, CARDIZEM LA, CARTIA XT, DILT CD, DILTZAC, TAZTIA XT, Tiazac), verapamil (CALAN, CALAN SR, COVERA-HS, Verelan, Verelan PM), and conivaptan (Vaprisol)
• nefazodone which is a medicine used to treat depression
• Birth control pills
• St. John’s Wort
• ginkgo
• resveratrol
• cimetidine
• Digoxin

This is not a complete list of flibanserin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with flibanserin including the following: 

• Sleepiness is a common side effect of flibanserin and can be serious. Taking flibanserin can increase your risk of sleepiness if taken during waking hours, if you drink alcohol, or take certain medicines or herbal supplements.
• Low blood pressure and fainting (loss of consciousness). It can happen when you take flibanserin even if you do not drink alcohol or take other medicines or herbal supplements. If you take flibanserin and you feel lightheaded or dizzy, lie down right away. Get emergency medical help or ask someone to get emergency medical help for you if the symptoms do not go away or if you faint (lose consciousness). If you faint (lose consciousness), tell your doctor as soon as you can. Your risk of severe low blood pressure and fainting (loss of consciousness) is increased if you take flibanserin and:
  • ​drink alcohol. Do not drink alcohol if you take flibanserin. 
  • take certain prescription medicines, over-the-counter medicines, or herbal supplements. Do not take or start taking any prescription medicines, over-the-counter medicines, or herbal supplements while taking flibanserin until you have talked with your doctor. Your doctor will tell you if it is safe to take other medicines or herbal supplements while you are taking flibanserin. 
  • have liver problems. Do not take flibanserin if you have liver problems. 

Do not drink alcohol when taking flibanserin. Flibanserin can cause drowsiness, dizziness, and fainting, especially when used with alcohol. Do not drive or operate heavy machinery until you know how flibanserin affects you. 

This medication is only available through the Addyi risk evaluation and mitigation strategy (REMS) Program because of the increased risk of severe low blood pressure and fainting (loss of consciousness) with alcohol use. You can only get this medication from pharmacies that are enrolled in the Addyi REMS Program. For more information about the Program and a list of pharmacies that are enrolled in the Addyi REMS Program, go to www.AddyiREMS.com or call 1-844-PINK-PILL (1-844-746-5745).

Do not take flibanserin if you:

• are allergic to flibanserin or to any of its ingredients
• drink alcohol
• have liver problems
• take medications that are strong CYP3A4 inhibitors such as clarithromycin, telithromycin, indinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir, ketoconazole, itraconazole, posaconazole, voriconazole, conivaptan (Vaprisol), delaviridine (Rescriptor), and nefazadone

Grapefruit and grapefruit juice may interact with flibanserin and lead to potentially dangerous effects. Do not drink grapefruit juice if you take flibanserin. Drinking grapefruit juice during your treatment with flibanserin increases your risk of severe low blood pressure and fainting (loss of consciousness).

Before taking flibanserin tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to flibanserin or to any of its ingredients
• drink alcohol, use drugs, or have a history of alcohol or drug abuse
• have ever had depression or other mental health problems
• have low blood pressure or a medical condition that can cause low blood pressure
• are pregnant or plan to become pregnant. It is not known if flibanserin will harm your unborn baby.
• are breastfeeding or plan to flibanserin. It is not known if flibanserin passes into your breast milk. You and your doctor should decide if you will take flibanserin or breastfeed. You should not do both
• have liver problems

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

It is not known if flibanserin will harm your unborn baby. There are no well-done studies that have been done in humans with flibanserin. In animal studies, pregnant animals were given flibanserin, and some babies had problems but were given high doses of flibanserin. Animal studies cannot rule out the potential for fetal harm.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if flibanserin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, breastfeeding is not recommended during treatment with flibanserin.

Take flibanserin exactly as prescribed.

Flibanserin comes in tablet form and is taken once daily, at bedtime. 

Take 1 flibanserin tablet one time a day at bedtime.

Take flibanserin only at bedtime. Taking flibanserin at a time other than bedtime can increase your risk of low blood pressure, fainting (loss of consciousness), accidental injury, and sleepiness.

If you miss a dose of flibanserin, skip your missed dose. Take your next dose at bedtime the next day. Do not take flibanserin the next morning or double your next dose. If you take too much flibanserin, call your doctor.

Tell your doctor if your symptoms of HSDD have not improved after you have taken flibanserin for 8 weeks.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Recommended dosage is 100 mg taken once daily at bedtime.

If you take too much flibanserin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store flibanserin at room temperature between 68°F to 77°F (20°C to25°C).
• Keep this and all medicines out of the reach of children.

WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS

Use of Addyi and alcohol increases the risk of severe hypotension and syncope; therefore, alcohol use is contraindicated.

Do NOT drink alcohol while taking Addyi.

Severe hypotension and syncope can oalso ccur when Addyi is used with moderate or strong CYP3A4 inhibitors or in patients with hepatic impairment; therefore, Addyi use in these settings is contraindicated.

Addyi is only available through the Addyi risk evaluation and mitigation strategy (REMS) Program because of the increased risk of severe low blood pressure and fainting (loss of consciousness) with alcohol use. You can only get Addyi from pharmacies that are enrolled in the Addyi REMS Program. For more information about the Program and a list of pharmacies that are enrolled in the Addyi REMS Program, go to www.AddyiREMS.com or call 1-844-PINK-PILL (1-844-746-5745).