Is Wakix a controlled substance?

Drugs.com

Official answer

by Drugs.com

No, Wakix (pitolisant) is not a controlled substance. In August 2019, Wakix was the first treatment approved for narcolepsy that was NOT classified as a controlled substance. It works by increasing the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain.

Wakix is classified as a histamine-3 (H₃) receptor antagonist/inverse agonist, a first-in-class medicine. Wakix binds to histamine 3 (H3) receptors to regulate the production and release of histamine in the brain, but its exact mechanism is not fully known.

Substances classified by the DEA as controlled substances typically have some level of abuse potential and addiction. Drugs used to treat narcolepsy are often classified as central nervous system (CNS) stimulants (with properties similar to amphetamines) or CNS depressants.

Medicines used for the treatment of narcolepsy that are listed as controlled substances include:

  • Adderall (amphetamine and dextroamphetamine): Schedule 2 (high potential for abuse)
  • Nuvigil (armodafinil): Schedule 4 (some potential for abuse)
  • Provigil (modafinil): Schedule 4 (some potential for abuse)
  • Sunosi (solriamfetol): Schedule 4 (some potential for abuse)
  • Xyrem (sodium oxybate): Schedule 3 (moderate potential for abuse)
  • Xywav (calcium / magnesium / potassium / sodium oxybates): Schedule 3 (moderate potential for abuse)

    • This is not all the information you need to know about Wakix (pitolisant) for safe and effective use. It does not take the place of talking to your doctor about your treatment. Review the full Wakix information here, and discuss this information and any questions you have with your healthcare provider.

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