From the Guidelines
Pregabalin is typically started at 50 mg three times daily or 75 mg twice daily and can be increased to 300 mg/day after 3-7 days, then by 150 mg/day every 3-7 days as tolerated, with a maximum recommended dose of 600 mg/day or 300 mg twice daily, as supported by the most recent evidence 1.
Key Considerations
- The dosage of pregabalin should be adjusted based on efficacy and tolerability, with gradual increases to minimize side effects such as dizziness, somnolence, peripheral edema, and weight gain.
- For patients with renal impairment, dose reduction is necessary, with a reduction of 50% if creatinine clearance is 30-60 mL/min.
- Treatment response should be evaluated after 4-6 weeks at a stable dose, and if inadequate relief occurs, consider either increasing the dose within the recommended range or adding/switching to another agent.
Mechanism of Action
- Pregabalin works by binding to calcium channels in the central nervous system, reducing the release of excitatory neurotransmitters involved in pain signaling, which helps alleviate the chronic widespread pain characteristic of fibromyalgia.
Recent Guidelines
- The 2022 CDC clinical practice guideline for prescribing opioids for pain recommends considering pregabalin for the treatment of fibromyalgia, along with other medications such as duloxetine and gabapentin 1.
- The 2022 Mayo Clinic Proceedings guideline for the management of chronic multisymptom illness also suggests offering pregabalin for the treatment of pain in patients with fibromyalgia 1.
From the FDA Drug Label
2.5 Management of Fibromyalgia in Adults The recommended dose of pregabalin for fibromyalgia is 300 to 450 mg/day. Begin dosing at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).
The recommended dose of Pregabalin (Lyrica) for the treatment of fibromyalgia is 300 to 450 mg/day. The dose should be started at 75 mg two times a day (150 mg/day) and may be increased based on efficacy and tolerability. 2
From the Research
Recommended Dose of Pregabalin for Fibromyalgia
- The recommended dose of pregabalin for the treatment of fibromyalgia is 300-450 mg per day, divided into two doses 3.
- Initial dosing of 25-50 mg at night is recommended due to potential side effects such as somnolence, dizziness, and cognitive dysfunction 3.
- Uptitration in weekly increments based on tolerability and therapeutic response is recommended, as side effects such as weight gain and peripheral edema are dose-related 3.
Efficacy of Pregabalin for Fibromyalgia
- Pregabalin has been shown to be effective in reducing pain and improving sleep and health-related quality of life in patients with fibromyalgia 3, 4, 5.
- A systematic review and meta-analysis found that pregabalin at a dose of 450 mg per day was most likely effective in treating fibromyalgia, although adverse events were not negligible 4.
- Another study found that pregabalin 300-600 mg produced a major reduction in pain intensity over 12-26 weeks with tolerable adverse events for a small proportion of patients with moderate or severe pain due to fibromyalgia 5.
Comparison of Dosing Regimens
- A double-blind randomized clinical trial compared the efficacy and safety of twice daily versus once nightly dosing of pregabalin for fibromyalgia, and found no significant difference between the two dosing regimens 6.
- However, the study did find that treatment-emergent adverse events were reported by significantly more patients in the twice daily group than those in the once nightly group 6.