Is Duloxetine (Cymbalta) a scheduled medication?

Duloxetine (Cymbalta) Scheduling Status

Duloxetine (Cymbalta) is not a scheduled medication under the Controlled Substances Act. It is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) used for treating various conditions including neuropathic pain, depression, and anxiety disorders 1.

Classification and Regulatory Status

• Duloxetine is an SSNRI antidepressant medication that does not appear in any of the five controlled substance schedules (I-V) 1
• It is approved by the FDA for multiple indications including diabetic peripheral neuropathy, major depressive disorder, generalized anxiety disorder, and fibromyalgia 2, 3
• Unlike opioid medications (such as tramadol) which are scheduled due to abuse potential, duloxetine does not have significant abuse liability 1

Clinical Applications

• Duloxetine is commonly prescribed as a first-line treatment for:
  • Painful diabetic peripheral neuropathy at doses of 60-120 mg daily 1, 2
  • Major depressive disorder at doses of 40-120 mg daily 4, 5
  • Generalized anxiety disorder at doses of 60-120 mg daily 3
  • Fibromyalgia at doses of 60-120 mg daily 2, 6
  • Osteoarthritis pain as a second-line or combination treatment 1

Prescribing Considerations

• Typical starting dose is 30 mg once daily for one week, then increased to 60 mg once daily 1, 5
• Maximum recommended dose is 60 mg twice daily (120 mg/day) 1, 3
• No special prescription forms or DEA number are required to prescribe duloxetine, unlike scheduled medications 5
• Duloxetine should be tapered when discontinuing to prevent withdrawal symptoms, especially after treatment longer than 3 weeks 1, 3

Safety Profile and Precautions

• Common adverse effects include nausea, dry mouth, headache, constipation, dizziness, and fatigue 1, 3

• Serious but rare adverse effects may include:

  • Hepatic failure (avoid in patients with liver disease) 1
  • Severe skin reactions including Stevens-Johnson syndrome 1
  • Suicidal thinking and behavior (through age 24 years) 1
  • Serotonin syndrome (especially when combined with MAOIs, which is contraindicated) 1, 3

• Duloxetine may interact with drugs metabolized by CYP1A2 and CYP2D6 1, 3

• Blood pressure monitoring is recommended as duloxetine can cause increases in some patients 3

Key Differences from Scheduled Medications

• Unlike scheduled medications, duloxetine:
  • Does not require special prescription pads or DEA authorization 5
  • Has no refill restrictions 5
  • Does not require special storage or disposal procedures 5
  • Is not subject to prescription monitoring programs 5

While duloxetine can cause physical dependence with withdrawal symptoms upon abrupt discontinuation, this is distinct from the psychological dependence and abuse potential that characterizes controlled substances 1, 3.