When Can a Patient Drive After Spravato Treatment?
Patients must not drive until the day after Spravato treatment, following a restful night's sleep. 1
Mandatory Waiting Period
The FDA-approved labeling for Spravato is explicit and unequivocal about driving restrictions:
- Do not drive, operate machinery, or engage in activities requiring complete alertness after taking Spravato
- Patients may only resume these activities the next day following a restful sleep 1
- A caregiver or family member must drive the patient home after each treatment session 1
This is not a flexible recommendation—it is a mandated safety requirement built into the REMS (Risk Evaluation and Mitigation Strategy) program under which Spravato is administered.
Clinical Evidence Supporting This Restriction
The driving restriction is based on rigorous on-road driving studies:
Next-Day Driving (18 Hours Post-Dose)
A controlled study in 25 patients with major depressive disorder demonstrated that driving performance 18 hours after a single 84 mg dose was equivalent to placebo, with no impairment in standard deviation of lateral position (SDLP), the validated measure of driving ability 1, 2. This provides the scientific basis for allowing driving the next day.
Same-Day Driving Is Unsafe
While repeated dosing studies showed no impairment at 6 hours post-dose during maintenance treatment 1, 2, the FDA label does not permit same-day driving because:
- Acute dissociative symptoms, sedation, dizziness, and perceptual disturbances occur immediately after dosing 1
- These effects typically resolve within 1.5 hours but can persist longer in some patients 1, 3
- Two subjects in driving studies had to discontinue testing after Spravato due to adverse effects (pressure behind eyes, paresthesia, headache with light sensitivity, anxiety) 1
Monitoring Requirements
The healthcare setting must observe patients for at least 2 hours post-dose to assess:
- Sedation level
- Dissociative symptoms
- Blood pressure (which can remain elevated for up to 4 hours) 1
- Overall clinical stability
The healthcare provider determines when the patient is ready to leave the facility—but this does NOT mean the patient can drive themselves 1.
Critical Pitfalls to Avoid
- Never allow patients to drive themselves to or from appointments—this must be arranged before initiating treatment
- Do not assume the 2-hour monitoring period means driving is safe after 2 hours—the restriction extends until the next day
- Weekend or evening dosing may be preferable to minimize disruption to patients' work schedules and transportation needs
- Patients on maintenance dosing (weekly or every-other-week) are subject to the same restrictions as those in the induction phase 1
Bottom Line
The driving restriction is absolute: no driving on the day of treatment, regardless of how the patient feels. This is a non-negotiable safety requirement that protects both the patient and public safety, supported by both FDA labeling 1 and validated driving performance studies 1, 2.