Flibanserin

What it is and how it works

Mechanism of Action The mechanism of action of ADDYI in the treatment of women less than 65 years of age with acquired, generalized HSDD as characterized by low sexual desire that causes marked distress or interpersonal difficulty (not due a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance) is not known.

Mechanism class: P-Glycoprotein Inhibitors

Indications

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: • 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 in men. • ADDYI is not indicated to enhance sexual performance.

Dosage and administration (summary)

• Recommended dosage is 100 mg taken once daily at bedtime • ADDYI is dosed at bedtime because administration during waking hours increases risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression • Discontinue ADDYI treatment after 8 weeks if no improvement 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) .

Contraindications

is contraindicated in patients: • Using concomitant moderate or strong CYP3A4 inhibitors . • With hepatic impairment . • 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 .

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. • 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.

Pregnancy

Pregnancy Risk Summary There are no studies of ADDYI in pregnant women to inform whether there is a drug-associated risk in humans. In animals, fetal toxicity only occurred in the presence of significant maternal toxicity including reductions in weight gain and sedation.

Storage and supply

is available as a 100 mg oval, pink, film-coated tablet debossed on one side with “f100” and blank on the other side. Available in bottles of 30 tablets. (NDC 58604-214-30) Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) .

Source: Flibanserin (Addyi) — US FDA prescribing information, 2025-12-22, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.