Zuranolone

, Dependence, Tolerance and/or Abuse Liability). Abuse and misuse can result in overdose or death, especially when combined with other Central Nervous System (CNS) depressant medicines such as benzodiazepines, opioids, alcohol or illicit drugs.

• Assess each patient’s risk prior to prescribing ZURZUVAE. • Monitor all patients regularly for the development of these behaviours or conditions. • ZURZUVAE should be stored securely to avoid theft or misuse.

Impairment of Alertness and Motor Coordination:

ZURZUVAE can cause impairment of psychomotor performance, which can increase the risk of accidents while driving, operating machinery, or performing other activities requiring alertness or physical coordination, such as caring for children.

• Patients should be warned not to drive, operate machinery, or engage in other potentially hazardous activities for at least 12 hours after taking ZURZUVAE for the duration of the 14-day treatment course. • If the patient is caring for their child, they should consider arranging for alternative childcare until they understand how the drug affects them, as it may impair their ability to care for their ZURZUVAE zuranolone capsules Page 5 of 34 Unclassified / Non classifié child.