What is the recommended dosage for Cyclopam (cyclobenzaprine)?

Cyclopam (Cyclobenzaprine) Dosage Recommendations

The recommended adult dose for Cyclopam (cyclobenzaprine) is one 15 mg extended-release capsule taken once daily, with some patients requiring up to 30 mg/day given as one 30 mg extended-release capsule or two 15 mg extended-release capsules taken once daily. 1

Immediate-Release Formulation Dosing

• For immediate-release formulation, the standard dosage is 5-10 mg three times daily (TID) 2
• Lower doses (5 mg TID) are as effective as higher doses (10 mg TID) with fewer side effects, particularly sedation 2
• Treatment duration should not exceed 2-3 weeks as longer use is not recommended 1

Extended-Release Formulation Dosing

• Extended-release capsules should be taken at approximately the same time each day 1
• Extended-release formulation provides sustained plasma concentrations compared to the fluctuating profile of immediate-release formulation 3
• The pharmacokinetic profile of extended-release 30 mg once daily is comparable to immediate-release 10 mg three times daily 3

Administration Guidelines

• Cyclopam extended-release capsules should be swallowed intact 1
• Alternatively, capsule contents may be sprinkled over applesauce and swallowed immediately without chewing 1
• When using the sprinkle method, patients should:
  • Sprinkle contents onto a tablespoon of applesauce and consume immediately without chewing 1
  • Rinse the mouth to ensure all contents have been swallowed 1
  • Discard any unused portion of the capsule 1

Efficacy Considerations

• Onset of relief is apparent within 3-4 doses of the 5 mg regimen 2
• Once-daily extended-release formulation has shown effectiveness in relieving acute muscle spasm based on patient ratings of medication helpfulness 4
• The 2.5 mg TID dose has not shown significant effectiveness compared to placebo 2

Safety and Tolerability

• Most common adverse effects are sedation, somnolence, dry mouth, dizziness, and fatigue 2, 5, 4
• Adverse effects are generally mild and dose-related 2
• Extended-release formulation (15 mg and 30 mg) has shown less reported daytime drowsiness and somnolence compared to immediate-release formulation 4

Special Considerations

• Combination therapy with cyclobenzaprine 5 mg TID plus ibuprofen has not shown superior efficacy compared to cyclobenzaprine 5 mg TID alone in patients with acute neck and back pain with muscle spasm 5
• Doses should be taken at regular intervals to maintain therapeutic effect 1

Common Pitfalls to Avoid

• Avoid treatment periods longer than 2-3 weeks as extended use is not recommended 1
• Avoid using foods other than applesauce for the sprinkle method as other foods have not been tested 1
• Be aware that sedation is dose-related; consider using lower effective doses (5 mg TID or 15 mg extended-release) to minimize this side effect 2, 4