What does Spravato require during a treatment session?
Spravato (esketamine) is given by healthcare professionals with specific session monitoring requirements. The prescribing information requires that after each dose, patients are observed in a setting where they can be monitored for adverse effects, particularly sedation and dissociation, and where emergency care is available if needed [1].
How long do patients stay for observation after each Spravato dose?
Patients are required to remain under observation for a set period after dosing (commonly referenced as at least the first 2 hours post-dose), with discharge allowed only if clinical criteria are met and the patient is stable [1].
What monitoring is done while the patient is in-clinic?
Session monitoring focuses on detecting and managing sedation and other acute effects from Spravato. The clinic must be able to assess the patient and respond promptly if sedation or other adverse reactions occur. This includes ongoing clinical observation during the post-dose period [1].
What safety requirements apply because Spravato can impair driving?
Spravato can impair judgment, thinking, and motor skills. Patients must not drive or operate machinery on the day of treatment, and they need to arrange for a safe ride home after the session as part of the session safety workflow [1].
What settings and staffing are required for Spravato administration?
Spravato must be administered in a healthcare setting capable of providing appropriate monitoring and emergency management during and after dosing, with trained personnel overseeing the session [1].
What happens if a patient isn’t safe to discharge?
If the patient shows concerning signs during the required observation period, the clinician can extend monitoring and delay discharge until the patient meets safety criteria [1].
Where can you find the exact monitoring language?
For the most precise details (including timing and what must be assessed), check the Spravato prescribing information and the associated REMS materials referenced by the manufacturer [1].
Sources:
[1] https://www.drugs.com/pro/spravato.html