Flibanserin 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.
Dosage & Administration
The recommended dosage of Flibanserin is 100 mg administered orally once per day at bedtime. Flibanserin 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). If a dose of Flibanserin 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.
Pediatric Use: Flibanserin is not indicated for use in pediatric patients.
Geriatric Use: Flibanserin is not indicated for use in geriatric patients. Safety and effectiveness have not been established in geriatric patients.
- Oral Contraceptives and Other Weak CYP3A4 Inhibitors: Increases flibanserin exposures and incidence of adverse reactions.
- Strong CYP2C19 Inhibitors: Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression.
- CYP3A4 Inducers: Use of flibanserin not recommended; flibanserin concentrations substantially reduced.
- Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.
Pregnancy & Lactation
Precautions & Warnings
Hypotension and Syncope with Flibanserin Alone: Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve.
Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with Flibanserin alone. Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least 6 hours after each dose and until they know how Flibanserin affects them.