Cyclobenzaprine (Flexeril) Is Not Recommended for Long-Term Management of Fibromyalgia
Cyclobenzaprine (Flexeril) should not be used for long-term management of fibromyalgia as it is only FDA-approved for short-term use (up to 2-3 weeks) and lacks evidence supporting long-term efficacy. 1
Evidence Against Long-Term Cyclobenzaprine Use
The FDA drug label explicitly states that cyclobenzaprine:
- Is indicated only for short periods (up to two or three weeks)
- Lacks adequate evidence of effectiveness for more prolonged use
- Is intended for acute, painful musculoskeletal conditions of short duration 1
The 2017 EULAR recommendations for fibromyalgia management provide only a "weak for" recommendation for cyclobenzaprine, noting significant limitations:
- 85% of patients experienced side effects
- Only 71% completed clinical studies
- Only minimal improvement in sleep (not pain) at 12 weeks
- Similar improvement was seen with placebo 2
Recommended Alternatives for Fibromyalgia Management
First-Line Non-Pharmacological Approaches
- Aerobic and strengthening exercise - strongly recommended with proven benefits for quality of life 3
- Cognitive behavioral therapy (CBT) - recommended by both American College of Rheumatology and EULAR 3
- Heated pool therapy - recommended with Level IIa, Strength B evidence 3
Recommended Pharmacological Options
- Tramadol - recommended as first-line with strong evidence (Level Ib, Strength A) 2, 3
- Amitriptyline - effective for pain with sleep disturbance (effect size 1.033) 2, 3
- Duloxetine - recommended particularly for patients with pain and depression 3
- Pregabalin - FDA-approved for fibromyalgia with moderate effectiveness 3, 4
Treatment Approach for Fibromyalgia
For long-term management of fibromyalgia, follow this algorithm:
Start with non-pharmacological approaches:
- Individually tailored exercise program
- Cognitive behavioral therapy
- Heated pool therapy when available
Add pharmacological treatment based on symptom profile:
- Pain + sleep disturbance → Amitriptyline or pregabalin
- Pain + depression → Duloxetine
- Pain as predominant symptom → Tramadol (with caution regarding dependence)
For inadequate response after 4-6 weeks:
- Optimize dose of current medication
- Switch to alternative first-line agent
- Consider combination therapy
Important Cautions
- Avoid strong opioids - not recommended for fibromyalgia 2, 3
- Avoid corticosteroids - not recommended for fibromyalgia 2, 3
- Monitor for side effects of recommended medications, including blood pressure changes, cognitive effects, sedation, dizziness, weight gain, and nausea 3
While some studies have shown short-term benefits with cyclobenzaprine (patients 3 times more likely to report overall improvement 5), the evidence does not support its use beyond 2-3 weeks. A single-dose 10mg bedtime regimen showed similar efficacy with fewer side effects compared to 30mg/day in divided doses, but still only for short-term use 6.
The meta-analysis by Tofferi et al. calculated that 4.8 individuals would need treatment for 1 patient to experience symptom improvement with cyclobenzaprine, but long-term efficacy data is lacking 5.