What are the recommended treatments for managing fibromyalgia?

Fibromyalgia Management

Start with Non-Pharmacological Interventions First

Begin treatment with aerobic and strengthening exercise as the primary intervention, as this has the strongest evidence (Level Ia, Grade A) for improving pain, function, and quality of life in fibromyalgia. 1

Exercise Protocol

• Start with low-intensity aerobic exercise (10-15 minutes of walking, swimming, or cycling) 2-3 times weekly, gradually increasing intensity based on tolerance to avoid symptom flare-ups 1, 2
• Individually tailor the exercise program and increase gradually over weeks to months 1
• Heated pool treatment with or without exercise is particularly effective (Level IIa, Grade B) 1

Cognitive Behavioral Therapy

• Add CBT specifically for patients with concurrent mood disorders, depression, anxiety, or maladaptive coping strategies (Level Ia, Grade A) 1, 2
• CBT shows strongest benefit in those with psychological comorbidities 2

Additional Non-Pharmacological Options

• Acupuncture provides pain relief (Level Ia, Grade A) 1
• Meditative movement therapies (qigong, yoga, tai chi) and mindfulness-based stress reduction improve symptoms (Level Ia, Grade A) 1
• Multicomponent therapies combining different approaches show greater benefit than single interventions (Level Ia, Grade A) 1

Add Pharmacological Treatment if Insufficient Response After 4-6 Weeks

If non-pharmacological interventions provide inadequate relief after 4-6 weeks, add one of three first-line medications: amitriptyline, duloxetine, or pregabalin. 1, 2

First-Line Medication Options

Amitriptyline (Off-Label but Highly Effective)

• Start at 10 mg at bedtime, increase by 10 mg weekly to target 25-50 mg nightly 1, 2
• Maximum dose 75 mg/day 1
• Number needed to treat for 50% pain relief is 4.1 (meaning 1 in 4 patients achieves substantial benefit) 2
• Particularly beneficial for patients with prominent sleep disturbances due to sedating properties 1
• Therapeutic effects typically emerge over 3-7 weeks 2
• Avoid in older adults ≥65 years due to anticholinergic effects 1
• Monitor for anticholinergic effects (dry mouth, constipation, urinary retention) and morning sedation 2
• Evidence Level Ia, Grade A 1

Duloxetine (FDA-Approved)

• Start at 30 mg once daily for 1 week, then increase to 60 mg once daily 1, 2, 3
• Target dose is 60 mg/day 1, 3
• Do not exceed 60 mg/day—doses above 60 mg provide no additional benefit but increase adverse events 1, 3
• Benefits include pain reduction, improved function, and treatment of comorbid depression 1, 2
• Evidence Level Ia, Grade A 1

Pregabalin (FDA-Approved)

• Start at 75 mg twice daily (150 mg/day), increase to 150 mg twice daily (300 mg/day) within 1 week based on tolerance 1, 2, 4
• Target dose range is 300-450 mg/day 1, 4
• Do not exceed 450 mg/day—doses above 450 mg provide no additional benefit but increase adverse events 1, 4
• Benefits include pain reduction and improved sleep 1, 2
• Requires dose adjustment in renal impairment (creatinine clearance <60 mL/min) 1, 4
• Evidence Level Ia, Grade A 1

Second-Line Medication Options

Milnacipran (FDA-Approved)

• Dose 100-200 mg/day in divided doses 1
• Titrate up over approximately 1 week to minimize side effects 1
• Similar efficacy to duloxetine for pain reduction 1
• Evidence Level Ia, Grade A 1

Cyclobenzaprine

• Can be considered for pain management (Level Ia, Grade A) 1
• Useful for muscle-related symptoms 1

Tramadol

• Use only when first-line medications are ineffective 1, 2
• Evidence Level Ib, Grade A 1
• Use with caution given opioid-related risks including dependence and tolerance 1

Gabapentin (Off-Label Alternative to Pregabalin)

• Not FDA-approved for fibromyalgia but shares similar mechanism with pregabalin 1
• Requires careful titration due to nonlinear pharmacokinetics (saturable absorption) 1
• Limited evidence with only one adequately powered study showing 49% of patients achieved ≥30% pain reduction vs 31% with placebo 2
• Requires dose adjustment in renal impairment 1

Medications to Absolutely Avoid

• Never prescribe corticosteroids—they lack efficacy for fibromyalgia 1, 2
• Never prescribe strong opioids—they have not demonstrated benefits and cause significant harm 1, 2
• NSAIDs should not be used as monotherapy—no evidence of benefit over placebo 1

Treatment Algorithm Summary

1. Weeks 0-4: Patient education + aerobic/strengthening exercise program + heated pool therapy 1, 2
2. Weeks 4-6: If insufficient response, add CBT (especially if mood disorders present) + continue exercise 1, 2
3. Week 6+: If still insufficient response, add one first-line medication (amitriptyline, duloxetine, or pregabalin) 1, 2
4. Week 10-12: Reassess every 4-8 weeks using pain scores, functional status, and patient global impression of change 1
5. If partial response: Consider adding another first-line medication from a different class 1
6. If no response: Switch to alternative first-line medication 1

Critical Pitfalls to Avoid

• Do not escalate duloxetine beyond 60 mg/day or pregabalin beyond 450 mg/day—no additional benefit, only increased adverse events 1, 3, 4
• Do not rely solely on pharmacological therapy without implementing exercise and behavioral approaches—non-pharmacological interventions have the strongest evidence 1
• Do not add gabapentin to pregabalin—they bind to identical targets with the same mechanism, making this combination pharmacologically redundant 1
• Do not expect dramatic improvements—most treatments show small to moderate benefits, and only about 1 in 4 patients achieves substantial pain relief with any single medication 1, 2
• Do not continue ineffective medications—only one-fifth of patients continue treatment for ≥1 year, suggesting many discontinue due to lack of efficacy or tolerability 5

Reassessment and Monitoring

• Evaluate treatment efficacy every 4-8 weeks using pain scores, functional status, and patient global impression of change 1
• Most patients remain on the same medication dose throughout treatment without escalation 5
• Therapeutic effects of amitriptyline typically emerge over 3-7 weeks 2
• Combination of non-pharmacological and pharmacological approaches may be more effective than either alone 1