FULL PRESCRIBING INFORMATION WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS 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)]. 1 INDICATIONS AND USAGE 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. 2 DOSAGE AND ADMINISTRATION 2.1 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). 2.2 Missed Dose If a dose of ADDYI 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. 2.3 Discontinuation of ADDYI Discontinue ADDYI after 8 weeks if the patient does not report an improvement in her symptoms. Reference ID: 4865026