Is Keppra (levetiracetam) a controlled substance?

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Is Keppra a Controlled Substance?

No, Keppra (levetiracetam) is not a controlled substance. It is an antiepileptic medication that is not scheduled under the Controlled Substances Act, as it does not have significant potential for abuse or dependence 1.

Classification and Pharmacological Properties

Levetiracetam (Keppra) is a second-generation antiepileptic drug with a unique chemical structure and mechanism of action that differs from traditional antiepileptic medications. It works primarily by:

  • Binding to synaptic vesicle protein 2A (SV2A)
  • Inhibiting calcium release from intraneuronal stores
  • Opposing negative modulators of GABA and glycine-gated currents
  • Inhibiting N-type calcium channels 2

Unlike controlled substances such as benzodiazepines or barbiturates, Keppra:

  • Does not produce euphoria
  • Has minimal abuse potential
  • Does not require special prescription regulations
  • Can be refilled without the restrictions that apply to controlled medications

Clinical Use and Advantages

Keppra is FDA-approved for:

  • Adjunctive therapy for partial-onset seizures in patients 16 years and older
  • Treatment of myoclonic seizures in juvenile myoclonic epilepsy
  • Treatment of primary generalized tonic-clonic seizures 2, 3

Key advantages of levetiracetam include:

  • Nearly ideal pharmacokinetics with rapid and complete absorption
  • Minimal protein binding (<10%)
  • Linear kinetics
  • Minimal metabolism independent of cytochrome P450 system
  • No significant drug-drug interactions 3

Formulations and Administration

Keppra is available in multiple formulations:

  • Immediate-release tablets
  • Extended-release tablets (Keppra XR)
  • Oral solution
  • Intravenous solution 4

The extended-release formulation allows for once-daily dosing, which may improve medication adherence 5.

Side Effects and Monitoring

Common adverse effects include:

  • Somnolence
  • Irritability
  • Dizziness
  • Nausea
  • Behavioral changes 3

Unlike controlled substances, Keppra:

  • Does not require special monitoring for abuse
  • Is not associated with physical dependence
  • Does not typically cause withdrawal symptoms when discontinued (though abrupt discontinuation should be avoided due to risk of increased seizure activity)

Comparison to Other Antiepileptic Drugs

When comparing Keppra to other antiepileptic medications:

  • Non-controlled antiepileptics: Similar to Keppra, medications like valproic acid, lamotrigine, and topiramate are not controlled substances 1.

  • Controlled antiepileptics: Some antiepileptic drugs are controlled substances, such as:

    • Phenobarbital (Schedule IV)
    • Phentermine/topiramate extended-release (Schedule IV) 1

Clinical Implications

The non-controlled status of Keppra offers several practical advantages:

  • Easier prescription process for providers
  • Fewer restrictions on refills
  • No special storage requirements in pharmacies
  • Reduced stigma for patients
  • Simpler management for patients who travel internationally

This classification reflects the medication's safety profile and low potential for abuse, making it a convenient option for long-term seizure management.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Levetiracetam.

Drugs of today (Barcelona, Spain : 1998), 2007

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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