ZURZUVAE

, 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.

• Patients should be cautioned that impairment may persist beyond 12 hours in some individuals, and patients may not be able to reliably assess their own level of impairment (see 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery; Childcare).

• Patients should be cautioned that CNS depressant effects of ZURZUVAE are amplified when taken with other CNS depressants, which can increase the severity of psychomotor performance impairment and sedative effects of ZURZUVAE. 2 Recommended Dose and Dosage Adjustment).

Suicidal thoughts and behaviour:

Antidepressants increased the risk of suicidal thoughts and behaviour in pediatric and young adult patients in short-term clinical trials. • Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation type and/or suicidal thoughts and behaviors.

3 Pediatrics). 4. 1. 2 Recommended Dose and Dosage Adjustment). 2 Recommended Dose and Dosage Adjustment). • Zuranolone is metabolized by CYP3A. 4 Drug-Drug Interactions). 2 Recommended Dose and Dosage Adjustment). • Retreatment with ZURZUVAE is not recommended.

This is based on its CNS depressant effects, potential for abuse, and the lack of efficacy and safety data beyond a single 14-day course of treatment with a 31-day follow-up period (see 7 Warnings and Precautions, Dependence, Tolerance and/or Abuse Liability; 7 Warnings and Precautions, CNS Depressant Effect; and 8 Adverse Reactions).