Gabapentin enacarbil

(Horizant®)

Gabapentin enacarbil

Drug updated on 12/11/2024

Dosage FormTablet (oral; 300 mg, 600 mg)
Drug ClassAntiepileptic
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.

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Summary
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  • 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 TitleYearSource
Horizant (gabapentin enacarbil) Prescribing Information.2022Azurity Pharmaceuticals, Inc., Woburn, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
The Management of Restless Legs Syndrome: An Updated Algorithm.2021Mayo Clinic Proceedings