DEA Number Not Required for Duloxetine
No, you do not need a DEA number to prescribe duloxetine because it is not a controlled substance. Duloxetine is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and does not appear in any of the five DEA controlled substance schedules (I-V) 1.
Regulatory Classification
- Duloxetine has no abuse potential and is not regulated under the Controlled Substances Act, unlike opioid medications which do require DEA registration 1.
- The medication is FDA-approved for multiple indications including major depressive disorder, diabetic peripheral neuropathic pain, fibromyalgia, generalized anxiety disorder, and chronic musculoskeletal pain 2, 1.
- Both the FDA and European Medicines Agency have approved duloxetine specifically for painful diabetic peripheral neuropathy at doses of 60-120 mg daily 2.
Prescribing Requirements
- Any licensed physician, nurse practitioner, or physician assistant with prescribing authority can prescribe duloxetine using only their state medical license and NPI number 1.
- Standard prescription requirements apply (patient name, medication name, dose, quantity, directions), but no DEA number is necessary on the prescription 1.
Clinical Context
- Duloxetine is commonly used as a first-line treatment for painful diabetic peripheral neuropathy with a number needed to treat (NNT) of 5-6 for 50% pain reduction at 12 weeks 3.
- The typical starting dose is 30 mg once daily for one week, then increased to 60 mg once daily, with a maximum recommended dose of 120 mg daily 1.
- Common adverse effects include nausea, dry mouth, headache, constipation, and dizziness, but serious adverse events are rare 4, 3.
Common Pitfall to Avoid
- Do not confuse duloxetine with tramadol or other opioid analgesics that are also used for neuropathic pain but DO require a DEA number, as tramadol is a Schedule IV controlled substance 2.