What is the maximum recommended dose of pregabalin (Lyrica) for a patient with fibromyalgia?

From the Guidelines

The maximum recommended dose of pregabalin (Lyrica) for fibromyalgia patients is 450 mg per day, typically divided into two or three equal doses. This dosage is based on the most recent and highest quality study available, which suggests that pregabalin is effective in reducing pain and improving functional status in patients with fibromyalgia 1. Treatment usually begins at a lower dose of 75 mg twice daily (150 mg/day) and may be increased to 150 mg twice daily (300 mg/day) within one week based on efficacy and tolerability. If necessary, the dose can be further increased to the maximum 450 mg/day after an additional week.

Some key points to consider when prescribing pregabalin for fibromyalgia include:

• Patients with renal impairment require dose adjustments based on creatinine clearance
• Common side effects include dizziness, somnolence, dry mouth, edema, and weight gain, which may be minimized by starting at lower doses and gradually titrating upward
• Pregabalin works by binding to voltage-gated calcium channels in the central nervous system, reducing the release of excitatory neurotransmitters involved in pain signaling
• This mechanism helps decrease pain sensitivity and improve sleep quality in fibromyalgia patients, though full benefits may take several weeks to develop
• Other treatment options for fibromyalgia, such as cognitive-behavioral therapy, mindfulness-based therapies, and exercise, may also be beneficial and can be used in conjunction with pregabalin 2.

It's worth noting that while the study by 2 provides recommendations for the management of chronic multisymptom illness, including fibromyalgia, it does not specifically address the maximum recommended dose of pregabalin. However, the study by 1 provides more detailed information on the use of pregabalin for fibromyalgia, including the recommended dosage.

From the FDA Drug Label

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). Although pregabalin was also studied at 600 mg/day, there is no evidence that this dose confers additional benefit and this dose was less well tolerated In view of the dose-dependent adverse reactions, treatment with doses above 450 mg/day is not recommended [see ADVERSE REACTIONS (6.1)].

The highest recommended dose of pregabalin for a patient with fibromyalgia is 450 mg/day 3.

From the Research

Maximum Recommended Dose of Pregabalin for Fibromyalgia

• The maximum recommended dose of pregabalin (Lyrica) for a patient with fibromyalgia is 450 mg per day, divided into two or three doses 4, 5, 6.
• Studies have shown that pregabalin at doses of 300, 450, and 600 mg per day is effective in reducing pain and improving sleep and health-related quality of life in patients with fibromyalgia 5, 6, 7.
• However, the optimal dose of pregabalin for fibromyalgia may vary depending on individual patient characteristics and symptoms, and should be customized accordingly 7.

Dose-Related Side Effects

• Common side effects of pregabalin include dizziness, somnolence, weight gain, and peripheral edema, which are dose-related 4, 5, 6.
• The incidence of adverse events is higher with higher doses of pregabalin, with the 600 mg per day dose having the highest rate of adverse events 5, 6.
• The lowest rate of adverse events was observed with the 300 mg per day dose 7.

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, with a moderate therapeutic benefit above placebo in up to 50% of patients 5, 8.
• The durability of clinically meaningful pain relief with pregabalin has been demonstrated for at least 6 months, but longer-term studies are required to determine the long-term efficacy of pregabalin for fibromyalgia 8.