Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 300 mg, 600 mg) |
Drug Class | Antiepileptic |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults
- Indicated for the management of postherpetic neuralgia (PHN) in adults.
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Gabapentin enacarbil is recommended as the first-line treatment for restless legs syndrome (RLS) due to its effectiveness and low risk of augmentation, particularly in primary RLS populations.
- In drug efficacy comparisons, cabergoline demonstrated the most significant reduction in International Restless Legs Study Group Severity Rating Scale (IRLS) scores (mean difference (MD) -11.98, 95% confidence interval (CI) -16.19 to -7.78), while pramipexole was more effective than ropinirole (MD -2.52, 95% CI -4.69 to -0.35).
- Iron supplementation showed efficacy in RLS patients with iron deficiency (MD -5.15, 95% CI -8.99 to -1.31), but was ineffective in patients with normal serum ferritin levels (MD -2.22, 95% CI -6.99 to 2.56).
- Common adverse effects reported include nausea, somnolence, fatigue, headache, and nasopharyngitis, with gabapentin enacarbil favored for its good tolerability and lower likelihood of augmentation.
- Alpha-2-delta ligands, particularly gabapentin enacarbil, demonstrate a favorable safety profile and are well-tolerated in both primary and secondary RLS populations.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Horizant (gabapentin enacarbil) Prescribing Information. | 2022 | Azurity Pharmaceuticals, Inc., Woburn, MA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
The Efficacy and Safety of Pharmacological Treatments for Restless Legs Syndrome: Systemic Review and Network Meta-Analysis | 2021 | Frontiers in Neuroscience |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
The Management of Restless Legs Syndrome: An Updated Algorithm. | 2021 | Mayo Clinic Proceedings |