From the Research
Perampanel is not recommended for use in neonates due to insufficient safety and efficacy data in this age group. This antiepileptic medication, which works as an AMPA glutamate receptor antagonist, is currently only FDA-approved for patients 4 years and older for partial-onset seizures and 12 years and older for primary generalized tonic-clonic seizures 1. The developing neonatal brain has unique characteristics that make medication effects unpredictable compared to older children and adults. Neonates have immature hepatic enzyme systems that would affect perampanel metabolism, potentially leading to unpredictable drug levels and increased risk of toxicity. Additionally, perampanel's long half-life (approximately 105 hours in adults) could pose particular challenges in neonates whose clearance mechanisms are not fully developed.
Some key points to consider when evaluating the use of perampanel in pediatric patients include:
- The efficacy and safety of perampanel have been established in children 12 years of age and over, but not in neonates 1
- Perampanel has been shown to be effective in reducing seizure frequency in pediatric patients with focal-onset seizures, but the evidence is limited to children 4 years and older 2
- The safety profile of perampanel in pediatric patients is generally favorable, but the risk of adverse events such as somnolence, dizziness, and behavioral changes must be carefully considered 3
- Perampanel may be a useful treatment option for pediatric patients with epilepsy, but its use in neonates is not supported by the current evidence 4, 5
If seizure control is needed in neonates, established first-line treatments with better-documented safety profiles such as phenobarbital, levetiracetam, or phenytoin should be considered instead. Any use of perampanel in neonates would be considered highly experimental and should only occur within a carefully monitored research protocol after exhausting standard treatment options.