What protocol should be in place when administering Spravato (esketamine)?

Spravato (Esketamine) Administration Protocol

Spravato must be administered under direct healthcare provider supervision with mandatory post-dose monitoring for at least 2 hours, blood pressure assessment before and approximately 40 minutes after dosing, and patients must not drive or operate machinery until the next day after restful sleep. 1

Pre-Administration Requirements

Patient Preparation

• Instruct patients to avoid food for at least 2 hours before administration to reduce risk of nausea and vomiting 1
• Avoid drinking liquids for at least 30 minutes prior to administration 1
• Patients requiring nasal corticosteroids or decongestants must administer these at least 1 hour before Spravato 1

Baseline Assessment

• Measure blood pressure prior to administration; in patients with pre-existing hypertension (>140 mmHg systolic or >90 mmHg diastolic), carefully weigh risks of short-term blood pressure increases against treatment benefits 1
• Do not administer if blood pressure or intracranial pressure elevation poses serious risk 1
• Ensure respiratory support equipment is immediately available, as dissociative symptoms and potential respiratory effects require monitoring 2, 3

Administration Protocol

Dosing Procedure

• Spravato is for intranasal use only under direct healthcare provider supervision 1
• Do not prime the nasal spray device before use to prevent medication loss 1
• For 56 mg dose: use 2 devices (each delivers 28 mg) 1
• For 84 mg dose: use 3 devices 1
• Allow a 5-minute rest period between use of each device 1

During Administration Monitoring

• Maintain continuous observation of the patient throughout the administration process 1
• Monitor for dissociative symptoms, which occur commonly (27.6% of patients) but are typically transient and resolve within 1.5 hours post-dose 3
• Watch for immediate adverse events including dizziness (32.9%), nausea (25.1%), and headache (24.9%) 3

Post-Administration Monitoring Protocol

Mandatory Observation Period

• Observe patient for at least 2 hours after each treatment session until the patient is safe to leave 1
• This observation period addresses risks of sedation, dissociation, blood pressure changes, and cognitive impairment 1

Blood Pressure Monitoring

• Reassess blood pressure at approximately 40 minutes post-dose (corresponding to peak drug concentration) 1
• Continue blood pressure monitoring as clinically warranted 1
• Patient may be discharged at end of 2-hour monitoring period only if blood pressure is decreasing and patient appears clinically stable 1
• If blood pressure remains elevated or patient is not clinically stable, continue monitoring beyond 2 hours 1

Safety Assessments During Observation

• Monitor oxygen saturation continuously, particularly given the dissociative effects and potential for respiratory depression 2
• Assess for resolution of dissociative symptoms, which typically resolve within 1.5 hours but must be confirmed before discharge 3
• Evaluate patient's cognitive status and ability to safely leave the facility 3
• Watch for delayed nausea or other adverse effects 1

Discharge Instructions

Post-Treatment Restrictions

• Instruct patients not to engage in potentially hazardous activities, including driving motor vehicles or operating machinery, until the next day after restful sleep 1
• This restriction is mandatory regardless of how the patient feels at discharge 1

Follow-Up Considerations

• Schedule next treatment session according to prescribed frequency (twice weekly during induction, then individualized during maintenance) 1
• Provide emergency contact information for any delayed adverse effects 3

Common Pitfalls to Avoid

• Failing to maintain the full 2-hour observation period can result in discharge of patients who subsequently experience delayed dissociative symptoms or blood pressure changes 1
• Inadequate pre-treatment fasting increases risk of nausea and vomiting, which occurred in 25-33% of patients in clinical trials 1, 3
• Allowing patients to drive themselves home poses serious safety risk given the consciousness-altering effects that persist beyond the observation period 1
• Insufficient blood pressure monitoring in patients with baseline hypertension can miss clinically significant elevations requiring extended observation 1
• Lack of immediately available respiratory support equipment leaves providers unprepared for potential respiratory depression, particularly important given the dissociative effects 2, 3

Safety Profile Context

Long-term safety data from up to 1 year of treatment shows most adverse events occur on dosing days, are mild to moderate in severity, and resolve the same day, with only 9.5% of patients discontinuing due to adverse events 3. However, the requirement for supervised administration with extended monitoring remains essential throughout treatment duration 1, 4.