Can Patients Drive After Sublocade Injection?
Patients receiving Sublocade should be warned not to drive or operate dangerous machinery unless they are tolerant to the effects of buprenorphine and know how they will react to the medication. 1
FDA-Mandated Warning on Driving
The FDA label for buprenorphine (the active ingredient in Sublocade) explicitly states that buprenorphine may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. 1 This warning applies to all buprenorphine formulations, including the extended-release monthly injection (Sublocade).
Key Clinical Considerations
Timing and Tolerance Assessment
For patients already stabilized on sublingual buprenorphine (8-24 mg daily for ≥7 days) before receiving Sublocade, they should already be tolerant to buprenorphine's sedating effects and may be able to drive if they have demonstrated tolerance without impairment. 2
For patients receiving their first Sublocade injection, therapeutic plasma concentrations are achieved from the first injection and maintained throughout the treatment duration, meaning cognitive effects begin immediately. 3
The decision to drive should be based on whether the patient is tolerant to buprenorphine's effects and understands how they personally react to the medication. 1
Duration of Potential Impairment
Buprenorphine plasma concentrations from Sublocade are sustained at approximately 2 ng/mL or above throughout the monthly dosing interval. 4
After discontinuation of Sublocade, buprenorphine plasma concentrations decrease slowly over time, meaning effects persist well beyond the last injection. 3
Unlike cannabis (which requires avoiding driving for up to 12 hours depending on product type), 5 buprenorphine from Sublocade provides continuous exposure, so the impairment risk is ongoing rather than time-limited after each dose.
Practical Recommendations
Before Allowing Driving
Assess baseline tolerance: Patients who were stable on sublingual buprenorphine without sedation or cognitive impairment before transitioning to Sublocade are more likely to tolerate driving safely. 2
Monitor after first injection: Closely monitor patients after their first Sublocade injection for signs of sedation, cognitive impairment, or other effects that would preclude safe driving. 2
Individualize based on response: Only permit driving once the patient demonstrates they are tolerant to buprenorphine's effects and can safely operate a vehicle without impairment. 1
Ongoing Monitoring
Patients should be reassessed regularly (at least every 3 months) for any changes in cognitive function, sedation, or other effects that might impair driving ability. 5
Be particularly cautious with patients taking concomitant CNS depressants (benzodiazepines, alcohol, other sedating medications), as these create synergistic impairment risk. 5, 1
Common Pitfalls to Avoid
Do not assume all patients on Sublocade can drive safely: The FDA warning is explicit that patients should only drive if they are tolerant and know their individual response. 1
Do not ignore concomitant medications: Buprenorphine combined with other CNS depressants significantly increases impairment risk and may contraindicate driving even in otherwise tolerant patients. 1
Do not forget about hypotension risk: Buprenorphine can cause hypotension, particularly in patients with reduced blood volume or taking other medications affecting blood pressure, which could impair safe driving. 1
Document the discussion: Always document that you have warned the patient about driving risks and assessed their tolerance and understanding of how buprenorphine affects them personally. 1