Is Tramadol a Controlled Substance?
Yes, tramadol is classified as a Schedule IV controlled substance in the United States as of 2014, when the FDA reclassified it based on its potential for abuse and dependence. 1
Federal Classification
The U.S. Food and Drug Administration (FDA) took action in 2014 to reassign tramadol as an opioid and Schedule IV controlled substance under the Controlled Substances Act. 1
Schedule IV designation means tramadol has accepted medical use but carries a recognized potential for abuse and dependence, though lower than Schedule II or III opioids. 2
Under federal regulations, tramadol can be prescribed for up to a 90-day supply with refills permitted up to five times within six months of the original prescription date. 2
Clinical Implications of Controlled Status
This reclassification should prompt reconsideration of tramadol's use for short-term musculoskeletal pain in patients with cardiovascular disease, as it was previously recommended in acute coronary syndrome guidelines before its controlled substance designation. 1
Tramadol is recognized as having potential for addiction and other opioid-associated adverse events, including the development of narcotic bowel syndrome in approximately 6% of long-term users. 1
The controlled substance status reflects documented cases of tramadol dependence, with users reporting euphoria and doses ranging from 50 to 1500 mg per day in substance-dependent populations. 3
Prescribing Requirements
Prescribers must include their DEA number and state license information when writing tramadol prescriptions. 2
State-specific regulations may impose additional restrictions beyond federal law, including quantity limits and prescription monitoring program requirements. 2
Nurse practitioners and other prescribers must verify their state's specific regulations regarding prescribing authority for controlled substances, which may require collaborative agreements or supervision. 2