Excessive Sedation and Sudden Loss of Consciousness

• Patients are at risk of excessive sedation or sudden loss of consciousness during administration of ZULRESSO. 
• Because of the risk of serious harm, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring. Patients must be accompanied during interactions with their child(ren). 
• ZULRESSO is available only through a restricted program called the ZULRESSO REMS