Flibanserin
Flibanserin (sold as Addyi) is a bedtime pill for premenopausal and postmenopausal women under 65 with acquired, generalized hypoactive sexual desire disorder (HSDD), which means low sexual desire that causes marked distress.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Flibanserin (Addyi), on the market since about 2015, is a specialized bedtime medicine for women under 65 with acquired, generalized hypoactive sexual desire disorder (HSDD), meaning low desire that causes marked distress. It is thought to work by stimulating one serotonin receptor (5-HT1A) and blocking another (5-HT2A). Many women tolerate it reasonably well, but dizziness, sleepiness and nausea are common, which is partly why it goes at bedtime. The one thing to respect is its boxed warning (the label's strongest alert) for severe low blood pressure and fainting, made likelier by alcohol near a dose, moderate or strong CYP3A4 inhibitors (drugs that slow its breakdown) or any liver problem.
Clinical pearls
- After 1 or 2 drinks, wait at least 2 hours before dosing, and after 3 or more, skip that night's dose.
- Skip grapefruit juice and tell every prescriber you take Addyi, since fluconazole, clarithromycin, diltiazem and ciprofloxacin are off-limits with it.
- No driving for at least 6 hours after a dose, and never make up a missed dose the next morning.
- Expect a trial of about 8 weeks, and if desire has not improved by then, your prescriber will likely stop it.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Addyi can cause severe low blood pressure and fainting in certain situations. This is the most serious warning on the label.
- Alcohol: Mixing alcohol and Addyi close together raises the risk. Wait at least 2 hours after 1 or 2 drinks before taking it at bedtime. Skip your dose if you've had 3 or more drinks that evening.
- Certain medicines: Moderate or strong CYP3A4 inhibitors raise flibanserin levels and are not allowed with Addyi.
- Liver problems: Liver impairment raises flibanserin levels, so Addyi must not be used.
Watch for dizziness, lightheadedness or fainting.
Patient information guide A plain-language walkthrough of Flibanserin, written from its FDA label.
What Flibanserin is used for
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Flibanserin, sold as Addyi, is used for one condition.
- Addyi treats women under 65 with acquired, generalized hypoactive sexual desire disorder (HSDD), meaning low desire that causes marked distress or relationship difficulty.
- The low desire must not be due to another medical or psychiatric condition, relationship problems, or a medication or drug.
- Acquired means it developed after a time with no desire problems. Generalized means it happens regardless of stimulation, situation or partner.
- Addyi is not for men and not for improving sexual performance.
How Flibanserin works
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The exact way flibanserin works for HSDD isn't known. In lab studies, it stimulated serotonin 1A receptors and blocked serotonin 2A receptors. It also had moderate blocking effects at other serotonin receptors (2B and 2C) and a dopamine D4 receptor.
Flibanserin dosage
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Addyi is a tablet taken by mouth once daily at bedtime. Bedtime dosing lowers the chance of low blood pressure, fainting, injury and drowsiness.
- Missed dose: skip it and take the next dose at bedtime the next day. Don't double up.
- Your prescriber will likely stop it after 8 weeks if you don't notice improvement.
- If switching to or from a CYP3A4 inhibitor, timing matters. Start Addyi 2 weeks after the last dose of the inhibitor. Start the inhibitor 2 days after the last dose of Addyi.
Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Flibanserin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Hypoactive sexual desire disorder (HSDD)
- 100 mg administered orally once per day at bedtime
- Dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and CNS depression; discontinue after 8 weeks if the patient does not report an improvement in HSDD symptoms
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Recommended dosage is 100 mg taken once daily at bedtime (2.1) • ADDYI is dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (2.1) • Discontinue ADDYI treatment after 8 weeks if no improvement (2.3) 2.1 Recommended Dosage The recommended dosage of ADDYI is 100 mg administered orally once per day at bedtime. ADDYI is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation) . 2.2 Missed Dose If a dose of ADDYI is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day. Instruct the patient to not double the next dose. 2.3 Discontinuation of ADDYI Discontinue ADDYI after 8 weeks if the patient does not report an improvement in her HSDD symptoms. 2.4 Initiation of ADDYI Following Moderate or Strong CYP3A4 Inhibitor Use If initiating ADDYI following moderate or strong CYP3A4 inhibitor use, start ADDYI 2 weeks after the last dose of the CYP3A4 inhibitor. If initiating a moderate or strong CYP3A4 inhibitor following ADDYI use, start the moderate or strong CYP3A4 inhibitor 2 days after the last dose of ADDYI [see Warnings and Precautions (5.2) ].
2.1 Recommended Dosage The recommended dosage of ADDYI is 100 mg administered orally once per day at bedtime. ADDYI is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation) .
2.2 Missed Dose If a dose of ADDYI is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day. Instruct the patient to not double the next dose.
2.3 Discontinuation of ADDYI Discontinue ADDYI after 8 weeks if the patient does not report an improvement in her HSDD symptoms.
2.4 Initiation of ADDYI Following Moderate or Strong CYP3A4 Inhibitor Use If initiating ADDYI following moderate or strong CYP3A4 inhibitor use, start ADDYI 2 weeks after the last dose of the CYP3A4 inhibitor.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Flibanserin side effects
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Most side effects began within the first 14 days of treatment. The most common ones were:
Common side effects
- Dizziness
- Sleepiness (somnolence)
- Nausea
- Fatigue
- Trouble sleeping (insomnia)
- Anxiety
- Dry mouth
- Constipation
- Urinary tract infection
- Sinusitis
When to get medical help
- Fainting or feeling like you're about to faint. If you feel faint, lie flat right away and get medical help if it doesn't pass.
- Severe drowsiness or sedation that affects your alertness
- Swelling of the face, lips or mouth, hives, itching or trouble breathing, which can be signs of a serious allergic reaction
- Severe dizziness or very low blood pressure, especially after alcohol or when taking certain interacting medicines
Get help for fainting, severe drowsiness, or signs of an allergic reaction such as facial swelling, hives or trouble breathing.
Flibanserin warnings and precautions
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The biggest risk is severe low blood pressure and fainting. It's higher with alcohol, with moderate or strong CYP3A4 inhibitors, and in liver impairment.
- Addyi can also cause sleepiness and sedation.
- Avoid driving or machinery until at least 6 hours after a dose and until you know how it affects you.
- If you feel faint, lie flat and get medical help if it doesn't resolve.
- Allergic reactions, including anaphylaxis and angioedema (swelling), have been reported.
- Overdose may worsen side effects.
Flibanserin interactions
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Several substances can raise or lower flibanserin levels or add to its effects.
- Alcohol: raises the risk of low blood pressure, fainting and sedation.
- Moderate or strong CYP3A4 inhibitors (such as ketoconazole, clarithromycin, fluconazole, diltiazem, verapamil, grapefruit juice): contraindicated because they raise flibanserin levels.
- Multiple weak CYP3A4 inhibitors (such as oral contraceptives, cimetidine, fluoxetine, ginkgo): may raise levels.
- Other CNS depressants (such as opioids, benzodiazepines, diphenhydramine): more drowsiness.
- Strong CYP2C19 inhibitors: may raise levels.
- CYP3A4 inducers (such as carbamazepine, rifampin, St. John’s Wort): lower levels, not recommended.
- Digoxin: levels can rise, risking toxicity.
Interactions listed in the FDA-approved label
From the Flibanserin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Alcohol: Coadministration increased the risk of hypotension, syncope, and CNS depression compared to ADDYI alone or alcohol alone. Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more alcoholic drinks that evening.
- Other CNS depressants (diphenhydramine, opioids, hypnotics, benzodiazepines): Concomitant use may increase the risk of CNS depression (e.g., somnolence) compared to ADDYI alone. Discuss the concomitant use of other CNS depressants with the patient when prescribing ADDYI.
- Moderate or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, diltiazem, erythromycin, fluconazole, verapamil, grapefruit juice): Increases flibanserin exposure compared to ADDYI alone and increases the risk of hypotension and syncope. Concomitant use is contraindicated. If initiating ADDYI following one, start ADDYI 2 weeks after the last dose of the inhibitor; if initiating one following ADDYI, start it 2 days after the last dose of ADDYI.
- Weak CYP3A4 inhibitors (oral contraceptives, cimetidine, fluoxetine, ginkgo, ranitidine): Concomitant use of multiple weak CYP3A4 inhibitors may increase the risk of adverse reactions. Discuss the use of multiple weak CYP3A4 inhibitors with the patient when prescribing ADDYI.
- Strong CYP2C19 inhibitors (proton pump inhibitors, selective serotonin reuptake inhibitors, benzodiazepines, antifungals): May increase flibanserin exposure, which may increase the risk of hypotension, syncope, and CNS depression. Discuss the use of a strong CYP2C19 inhibitor with the patient when prescribing ADDYI.
- CYP3A4 inducers (carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapetine, St. John's Wort): Substantially decreases flibanserin exposure compared to ADDYI alone. Concomitant use is not recommended.
- Digoxin or other P-glycoprotein substrates (digoxin, sirolimus): Increases the digoxin concentration, which may lead to digoxin toxicity. Increase monitoring of concentrations of drugs transported by P-gp that have a narrow therapeutic index (e.g., digoxin).
Read the label’s full interactions text
7 DRUG INTERACTIONS Table 3 contains clinically significant drug interactions (DI) with ADDYI. Table 3 Clinically Significant Drug Interactions with ADDYI Alcohol Clinical Implications The coadministration of ADDYI with alcohol increased the risk of hypotension, syncope, and CNS depression compared to the use of ADDYI alone or alcohol alone [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.2) ]. Preventing or Managing DI Counsel patients to wait at least two hours after consuming one or two standard alcoholic drinks before taking ADDYI at bedtime or to skip their ADDYI dose if they have consumed three or more alcoholic drinks that evening. [see Boxed Warning , Warnings and Precautions (5.1) , and Adverse Reactions (6.1) ] . Other CNS Depressants Examples Diphenhydramine, opioids, hypnotics, benzodiazepines Clinical Implications The concomitant use of ADDYI with CNS depressants may increase the risk of CNS depression (e.g., somnolence) compared to the use of ADDYI alone. Preventing or Managing DI Discuss the concomitant use of other CNS depressants with the patient when prescribing ADDYI. Moderate or Strong CYP3A4 Inhibitors Examples of strong CYP3A4 inhibitors Ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan Examples of moderate CYP3A4 inhibitors Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice Clinical Implications The concomitant use of ADDYI with moderate or strong CYP3A4 inhibitors increases flibanserin exposure compared to the use of ADDYI alone. The risk of hypotension and syncope is increased with concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors [see Warnings and Precautions (5.2) , Adverse Reactions (6.1) , and Clinical Pharmacology (12.3) ].
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Flibanserin
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- Contraindicated with any degree of liver impairment.
- Contraindicated with moderate or strong CYP3A4 inhibitors.
- Contraindicated with known hypersensitivity to Addyi.
- Not recommended while breastfeeding.
- No human pregnancy studies. Animal studies cannot rule out fetal harm.
- Not for children, men, or women 65 and older.
- CYP2C19 poor metabolizers have higher flibanserin levels and need closer monitoring.
Flibanserin overdose
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An overdose may increase the number or severity of side effects such as low blood pressure, fainting and sedation. Treatment focuses on symptoms and supportive care. There is no known specific antidote.
What Flibanserin does in the body
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In lab studies, flibanserin stimulated serotonin 1A receptors and blocked serotonin 2A receptors. It had milder blocking effects at other serotonin receptors and a dopamine receptor. In a study of healthy volunteers, it did not meaningfully affect the heart's QT interval (an electrical timing measure). Heart rate rose slightly at three times the recommended daily dosage.
How your body processes Flibanserin
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About a third of Addyi reaches the bloodstream after swallowing. Levels peak in under an hour in many people. Food increases how much is absorbed. The body breaks it down mostly with the CYP3A4 enzyme, and to a lesser extent CYP2C19. Waste leaves in both urine and stool. Its half-life is about 11 hours, and steady levels are reached after about 3 days. In people with mild liver impairment, exposure was 4.5 times higher.
How to store Flibanserin
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Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Flibanserin
199 supplements and herbal products have documented interactions with Flibanserin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 9
- Moderate · 151
- Minor · 39
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Flibanserin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Flibanserin — the kind of thing our pharmacy team would talk through with you at the counter.
What is Addyi for?
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When and how should I take it?
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Can I drink alcohol with it?
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What side effects should I expect?
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When should I call my doctor or get help?
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Will I take it long term?
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Is Flibanserin available over the counter?
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When was Flibanserin first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Flibanserin on HelloPharmacist
Flibanserin forms and strengths (how it comes)
Flibanserin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Addyi is used for women under 65 with acquired, generalized HSDD.
- Addyi is not for men and is not meant to enhance sexual performance.
- Addyi is taken by mouth once a day at bedtime.
- If you miss a dose of Addyi, take the next dose at bedtime the next day. Do not double up.
- Addyi is generally stopped after 8 weeks if symptoms haven't improved.
Flibanserin on the U.S. market: products, makers and brands
How Flibanserin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Flibanserin product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2015. Brand names on the directory include Addyi; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Flibanserin products
A representative set of FDA-listed product records for Flibanserin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg | Oral | Sprout Pharmaceuticals, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Flibanserin NDCs →
Flibanserin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Flibanserin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Flibanserin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Flibanserin FDA approval history
How Flibanserin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Flibanserin was first approved by the FDA in 2015 (Brand: ADDYI · Sprout Pharms). It remains available in U.S. pharmacies today.
Source: Drugs@FDA.
Flibanserin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Flibanserin recalls since July 2021.
✅No Flibanserin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1665509 1 dose form · 1 strength
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Dose form (SCDF) Oral Tablet RxCUI 1665513In current FDA listingsClinical drug / strength (SCD) 100 MGRxCUI 1665514
Look up RxCUI 1665509 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Flibanserin supply and shortage status
Whether Flibanserin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Flibanserin brand names
Flibanserin is sold under one brand name in the FDA directory — Addyi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Flibanserin: manufacturers and labelers
One company lists Flibanserin products with the FDA. By number of product records, the largest are Sprout Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Flibanserin drug class (RxNorm)
Flibanserin belongs to the Other gynecologicals class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Flibanserin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Sprout Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →