Medically reviewed by Drugs.com. Last updated on May 5, 2021.
Applies to the following strengths: 100 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Hypoactive Sexual Desire Disorder
100 mg orally once a day at bedtime
-For patients with no improvement in hypoactive sexual desire disorder (HSDD) after 8 weeks, this drug should be discontinued.
-This drug is not indicated for the treatment of HSDD in postmenopausal women or in men.
-This drug is not indicated to enhance sexual performance.
Use: Treatment of premenopausal women with acquired, generalized HSDD 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.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Concomitant use with Moderate or Strong CYP450 3A4 Inhibitors: Contraindicated
-Flibanserin should not be started until 2 weeks after the last dose of a moderate or strong CYP450 3A4 inhibitor
-Strong or moderate CYP450 3A4 inhibitors should not be started for 2 days after the last flibanserin dose
-Use caution with multiple weak CYP450 3A4 inhibitors
Concomitant Use with Alcohol:
-To reduce the potential interaction with alcohol, patients consuming 3 or more standard alcoholic drinks should skip their daily (bedtime) dose; patients consuming 1 or 2 standard alcoholic drinks should wait at least 2 hours before dosing
-A standard alcoholic drink contains 14 g of pure alcohol and is equivalent to one 12-ounce regular beer (5% alcohol), 5-ounces wine (12% alcohol), or 1.5 ounces of distilled spirits/shot (40% alcohol).
-Once a patient has taken their bedtime dose, alcohol should not be consumed until the following day
US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Addyi. It includes elements to assure safe use and an implementation system. For additional information: www.fda.gov/REMS
US BOXED WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS:
-Interaction with Alcohol: The use of this drug and alcohol together close in time increases the risk of severe hypotension and syncope. Counsel patients to wait at least 2 hours after consuming 1 or 2 standard alcoholic drinks before taking this drug at bedtime or instruct them to skip the bedtime dose if they have consumed 3 or more standard alcoholic drinks that evening.
-Contraindicated with Strong or Moderate CYP450 3A4 Inhibitors: Concomitant use of this drug with strong or moderate CYP450 3A4 inhibitors increases the concentration of this drug, which can cause severe hypotension and syncope.
-Contraindicated in Patients with Hepatic Impairment: The concentration of this drug is increased when used in patients with hepatic impairment, which can result in severe hypotension and syncope.
-Concomitant use with moderate or strong CYP450 3A4 inhibitors
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available.
-Take orally once a day at bedtime
-Missed dose: If a dose is missed, skip the missed dose and resume dosing the next day at bedtime
-This drug should be only be taken at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and CNS depression (e.g., somnolence and sedation).
-If no improvement in HSDD is achieved in 8 weeks, this drug should be discontinued.
-Monitor for hypotension
-Monitor for somnolence, sedation, and fatigue
-Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
-Patients should understand that this drug may cause hypotension and syncope particularly when taken close in time with alcohol, grapefruit juice, or a number of different medications or herbal supplements; patients should discuss all medication and herbal use with their healthcare professional.
-Patients should understand that alcohol use should be limited, they should understand the limitations to avoid the risk of hypotension and syncope.
-Patients should be instructed to lie down if they experience lightheadedness; they should seek medical help promptly if symptoms persist.
-Patients should be instructed not to drive or engage in hazardous tasks until at least 6 hours after their last dose, and until they understand how this drug affects them.
Frequently asked questions
More about flibanserin
- Side Effects
- During Pregnancy
- Drug Interactions
- En Español
- 44 Reviews
- Drug class: miscellaneous central nervous system agents
- Other brands
Related treatment guides
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.