What is the dosage of Addyi?

Addyi is available in 1 dosages, including 100 mg Tab

What does Addyi treat?

Addyi treats Sexual Dysfunctions, Psychological

How is Addyi administered?

Addyi is administered as a Oral Pill

What is Addyi mechanism of action?

Addyi mechanism of action is P-Glycoprotein Inhibitors

Addyi

(flibanserin)

Check Drug InteractionsCheck known drug interactions.

Check Drug Interactions

Financial Assistance Programs

Get Prior Authorization Forms

Get Patient Education Materials

Dosage & 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 treatment after 8 weeks if no improvement (2.3)

PrescriberAI is currently offline. Try again later.

By using PrescriberAI, you agree to the AI Terms of Use.

This AI tool offers medical information for informational purposes only and is not a substitute for professional medical judgment or advice. Physicians and healthcare professionals should exercise their expertise and discretion when interpreting and applying the provided information to specific clinical situations.

Addyi Prescribing Information

Interaction with Alcohol

The use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope [see Warnings and Precautions (5.1)]. 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 standard alcoholic drinks that evening.

Contraindicated with Strong or Moderate CYP3A4 Inhibitors

The concomitant use of ADDYI and moderate or strong CYP3A4 inhibitors increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.2)]. Therefore, the use of moderate or strong CYP3A4 inhibitors is contraindicated in patients taking ADDYI [see Contraindications (4)].

Contraindicated in Patients with Hepatic Impairment

The use of ADDYI in patients with hepatic impairment increases flibanserin concentrations, which can cause severe hypotension and syncope [see Warnings and Precautions (5.5)]. Therefore, ADDYI is contraindicated in patients with hepatic impairment [see Contraindications (4)].

ADDYI is indicated for the treatment of premenopausal women 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:

•: A co-existing medical or psychiatric condition,
•: Problems within the relationship, or
•: The effects of a medication or other drug substance.

Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.

Limitations of Use

•: ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men.
•: ADDYI is not indicated to enhance sexual performance.

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)].

CYP2C19 Poor Metabolizers

CYP2C19 poor metabolizers had increased flibanserin exposures compared to CYP2C19 extensive metabolizers. Additionally, syncope occurred in a subject who was a CYP2C19 poor metabolizer [see Adverse Reactions (6.1) and Clinical Pharmacology (12.5)]. Therefore, increase monitoring for adverse reactions (e.g., hypotension) in patients who are CYP2C19 poor metabolizers. The frequencies of poor CYP2C19 metabolizers are approximately 2–5% among Caucasians and Africans and approximately 2–15% among Asians.

ADDYI is contraindicated in patients:

•: Using concomitant moderate or strong CYP3A4 inhibitors [see Boxed Warning and Warnings and Precautions (5.2)].
•: With hepatic impairment [see Boxed Warning and Warnings and Precautions (5.5)].
•: With known hypersensitivity to ADDYI or any of its components. Reactions, including anaphylaxis, reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth), pruritus, and urticaria have been reported [see Adverse Reactions (6.2)].

Addyi

Dosage & Administration

Addyi Prescribing Information

Initiation of ADDYI Following Moderate or Strong CYP3A4 Inhibitor Use

CYP2C19 Poor Metabolizers

Addyi Prior Authorization Resources

Most recent Addyi prior authorization forms

Most recent state uniform prior authorization forms

Addyi PubMed™ News

Addyi Patient Education

Patient toolkit