Description
Addyi is available by prescription only. Go ahead and place your purchase. After making payment, we will ensure that a valid prescription is received from your prescriber
Drug Label Highlights
Source: This information is taken from the official DailyMed drug label page when available. It is provided for educational purposes and is not a substitute for pharmacist counseling, prescriber instructions, or the full official labeling.
These highlights do not include all the information needed to use ADDYI safely and effectively.
See full prescribing information for ADDYI.
ADDYI (flibanserin) tablets, for oral use
Initial U.S. Approval: 2015
WARNING: HYPOTENSION and SYNCOPE IN CERTAIN SETTINGS
See full prescribing information for complete boxed warning.
Recent Major Changes
Indications and Usage (1)
12/2025
Indications And Usage
ADDYI is indicated for the treatment of women less than 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to (1):
Limitations of Use:
Dosage And Administration
Dosage Forms And Strengths
Tablets: 100 mg (3)
Contraindications
Warnings And Precautions
- Hypotension and Syncope due to an Interaction with Alcohol: After taking ADDYI at bedtime, advise patients to avoid alcohol until the following day. (5.1)
- Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with ADDYI alone. Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients should avoid activities requiring full alertness (e.g., driving or operating machinery) until at least six hours after each dose and until they know how ADDYI affects them. (5.3)
- Hypotension and Syncope with ADDYI Alone: Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve. (5.4)
- Hypersensitivity Reactions, including anaphylaxis, angioedema, pruritus, urticaria: Avoid in women with known hypersensitivity to ADDYI or any of its components (5.6)
- Hypotension and Syncope due to an Interaction with Alcohol: After taking ADDYI at bedtime, advise patients to avoid alcohol until the following day. (5.1)
- Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with ADDYI alone. Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients should avoid activities requiring full alertness (e.g., driving or operating machinery) until at least six hours after each dose and until they know how ADDYI affects them. (5.3)
- Hypotension and Syncope with ADDYI Alone: Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve. (5.4)
- Hypersensitivity Reactions, including anaphylaxis, angioedema, pruritus, urticaria: Avoid in women with known hypersensitivity to ADDYI or any of its components (5.6)
Adverse Reactions
Most common adverse reactions (incidence ≥2%) are dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation and dry mouth. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sprout Pharmaceuticals, Inc. at 1-844-746-5745, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Use In Specific Populations
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2025
DailyMed highlights last updated: 2026-06-24 22:04:12
Medication Guide
Medication Summary
Medication Summary: This section summarizes DailyMed drug label information to make the label easier to understand. It is not a substitute for the official label, pharmacist counseling, prescriber instructions, or medical advice.
Overview
ADDYI (flibanserin) is a prescription tablet taken by mouth at bedtime. It is indicated for certain women under 65 years of age with acquired, generalized hypoactive sexual desire disorder (HSDD) that causes marked distress or interpersonal difficulty and is not due to another medical, psychiatric, relationship, or medication-related cause.
The label says ADDYI is not indicated in men and is not used to enhance sexual performance. The recommended dose is 100 mg once daily at bedtime.
The label warns that ADDYI can cause low blood pressure, fainting, and sleepiness. These risks are higher when ADDYI is taken with alcohol close in time, with moderate or strong CYP3A4 inhibitors, or in people with hepatic impairment.
Common adverse reactions include dizziness, somnolence, nausea, fatigue, insomnia, urinary tract infection, anxiety, sinusitis, constipation, and dry mouth.
Storage Information
Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature]. store ADDYI? •Store ADDYI at room temperature between 68°F to 77°F (20°C to 25°C).
Key Counseling Points
- Take ADDYI once daily at bedtime.
- Do not take an extra dose if you miss a bedtime dose; take the next dose at bedtime the following day.
- Avoid alcohol until the following day after taking ADDYI at bedtime.
- If you have had 1 or 2 standard alcoholic drinks, wait at least 2 hours before taking ADDYI at bedtime; if you have had 3 or more drinks, skip that dose.
- Do not use ADDYI with moderate or strong CYP3A4 inhibitors.
- ADDYI is contraindicated in hepatic impairment.
- Avoid driving or operating machinery until at least 6 hours after taking ADDYI and until you know how it affects you.
- Contact a healthcare professional right away if fainting, near-fainting, or symptoms of low blood pressure occur.
- Stop ADDYI and get medical help if signs of hypersensitivity occur, such as swelling, itching, hives, or trouble with allergic reactions.
- If there is no improvement after 8 weeks, the label says ADDYI should be discontinued.
Helpful Patient Education
ADDYI (flibanserin) is an oral prescription tablet used for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in women less than 65 years of age, when low sexual desire causes marked distress or interpersonal difficulty and is not due to another medical, psychiatric, relationship, or medication-related cause. It is taken once daily at bedtime.
Educational product information should also note important safety warnings from the label, including risks of hypotension, syncope, and central nervous system depression. The label states that alcohol close in time to dosing, moderate or strong CYP3A4 inhibitors, and hepatic impairment increase these risks.
Medication Summary last generated: 2026-07-05 11:37:04
Addyi (flibanserin) --- 100 mg Tablets --- 30 Count --- For Female Erectile Dysfunction --- Sprout Pharma may require patient-specific counseling based on your prescription, directions, allergies, medical history, and other medications.
This Medication Guide section is provided for general educational purposes only. It does not replace the official medication guide, patient information leaflet, counseling from your pharmacist, or medical advice from your prescriber.
Please read all information provided with your prescription. Contact Pill Pals Pharmacy or your prescriber with questions before using this medication.
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