What are the FDA-approved treatments for fibromyalgia?

FDA-Approved Treatments for Fibromyalgia

Duloxetine, milnacipran, and pregabalin are the only FDA-approved medications for the treatment of fibromyalgia. 1, 2, 3

FDA-Approved Medications

1. Duloxetine (Cymbalta)

• FDA approval status: Approved for fibromyalgia
• Mechanism: Serotonin-norepinephrine reuptake inhibitor (SNRI)
• Standard dosing: 60 mg once daily 4
• Efficacy:
  • Most effective for pain and depression symptoms 3
  • Shows small to moderate improvements in pain, function, and quality of life 1
  • Superior to milnacipran and pregabalin in reducing depressed mood 5
• Common side effects: Dizziness, sedation, nausea 6

2. Pregabalin (Lyrica)

• FDA approval status: Approved for fibromyalgia
• Mechanism: Calcium channel alpha-2-delta ligand
• Standard dosing: 300-450 mg/day (divided doses) 7
• Efficacy:
  • Effective for pain and sleep quality improvement 7
  • Superior to milnacipran in reduction of pain and sleep disturbances 5
  • Shows small to moderate improvements in pain, function, and quality of life 1
• Common side effects: Dizziness, somnolence, weight gain, peripheral edema

3. Milnacipran (Savella)

• FDA approval status: Approved for fibromyalgia
• Mechanism: Serotonin-norepinephrine reuptake inhibitor (SNRI)
• Standard dosing: 100-200 mg/day (divided doses) 8
• Efficacy:
  • Superior to duloxetine in reducing fatigue 5
  • Shows small to moderate improvements in pain, function, and quality of life 1
• Common side effects: Nausea, headache, constipation, hot flush, hyperhidrosis, palpitations, increased heart rate, dry mouth, and hypertension 8

Real-World Prescribing Patterns

A real-world analysis of prescribing patterns found:

• Duloxetine had the longest mean duration of treatment (205 days) compared to pregabalin and milnacipran (both 167 days) 9
• Pregabalin was most likely to be prescribed at lower than recommended doses (35% of patients) compared to duloxetine (7%) or milnacipran (17%) 9
• More patients receiving duloxetine (91%) and milnacipran (80%) received recommended maintenance dosing compared to pregabalin (27%) 9

Comparative Effectiveness

According to network meta-analyses:

• Duloxetine 120 mg showed the highest improvement in pain and depression versus placebo 3
• Amitriptyline (though not FDA-approved) showed superior efficacy for improving sleep, fatigue, and overall quality of life 3
• No significant differences were found between the three FDA-approved medications for 30% pain relief 5

Clinical Approach to Medication Selection

1. For predominant pain with depression: Consider duloxetine first 3, 5
2. For predominant pain with sleep disturbance: Consider pregabalin first 3, 5
3. For predominant fatigue: Consider milnacipran first 5

Important Considerations and Caveats

• None of the FDA-approved medications are fully effective against the whole spectrum of fibromyalgia symptoms 2
• Avoid duloxetine in patients with chronic liver disease or severe renal impairment (GFR <30 mL/minute) 6
• Pregabalin may cause weight gain and cognitive effects, which may limit tolerability
• Milnacipran has more noradrenergic effects and may increase blood pressure and heart rate more than duloxetine 8
• All three medications are superior to placebo for pain relief, but have different efficacy profiles for other fibromyalgia symptoms 5

While these three medications are the only FDA-approved options for fibromyalgia, it's worth noting that amitriptyline is commonly used off-label and may be particularly effective for sleep disturbances and fatigue in fibromyalgia patients 3, 10.