Should you schedule benzonatate for a patient?

Benzonatate Should Not Be Scheduled as a Controlled Substance

Benzonatate should not be scheduled as a controlled substance, but it requires careful prescribing due to its safety profile and potential for fatal overdose.

Rationale for Non-Scheduling

Benzonatate is a non-opioid, peripherally acting antitussive that is chemically related to local anesthetics like procaine and tetracaine 1. While it has important safety considerations, the current evidence does not support scheduling it as a controlled substance:

• The American College of Chest Physicians recommends benzonatate as a fourth-line, non-opioid option for cough management 2
• It is typically prescribed at 100-200 mg three times daily, not exceeding 600 mg total daily dose 1
• Unlike opioid antitussives, benzonatate does not have significant abuse potential documented in the literature

Safety Considerations and Risks

Despite not requiring scheduling, benzonatate carries significant risks:

• Overdose risk: Fatal overdoses have been reported in both children and adults 3, 4
• Rapid onset of toxicity: Signs of overdose can appear within 15-20 minutes of ingestion 1, 4
• Serious adverse effects: Overdose can cause seizures, cardiac arrest, coma, respiratory arrest, and death 4
• Pediatric risk: Accidental ingestion resulting in death has been reported in children under 10 years 1, 5

Prescribing Guidelines

When prescribing benzonatate:

1. Patient selection:

   • Appropriate for patients who have failed first-line cough treatments 2
   • Use with caution in patients with cardiac conditions or risk factors for arrhythmias 2
   • Contraindicated in children under 10 years 1

2. Patient education (critical for safety):

   • Swallow capsules whole; do not break, chew, dissolve, cut, or crush 1
   • If numbness/tingling of mouth or throat occurs, avoid eating/drinking until resolved 1
   • Never exceed 200 mg in a single dose or 600 mg daily 1
   • Store securely away from children 1

3. Monitoring:

   • Assess for aspiration risk, particularly in frail patients 2
   • Monitor for potential cardiac effects, especially with concomitant medications affecting cardiac conduction 2

Therapeutic Positioning

Benzonatate should be positioned appropriately in the treatment algorithm:

1. First-line: Demulcents (syrups)
2. Second-line: Opioid derivatives (codeine, morphine)
3. Third-line: Other peripherally-acting antitussives
4. Fourth-line: Local anesthetics including benzonatate 2

Special Considerations

• Pregnancy: Category C - use only if clearly needed 1
• Nursing mothers: Unknown if excreted in breast milk; use caution 1
• Advanced cancer: May be particularly useful for opioid-resistant cough in advanced cancer 6, 7

While benzonatate has demonstrated efficacy for cough management and does not require scheduling as a controlled substance, its potential for serious adverse effects necessitates careful prescribing, thorough patient education, and appropriate monitoring.