Is Wakix a controlled substance?

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)

Related: Scheduling in the Controlled Substances Act (CSA)

What does Wakix treat?

Wakix is approved by the FDA for the treatment of excessive daytime sleepiness (EDS) or cataplexy (sudden loss of muscle strength) in adults with narcolepsy.

• Narcolepsy is characterized by immense daytime drowsiness and sudden attacks of sleep. Wakix was approved for treatment of narcolepsy in adults in August 2019.
• Cataplexy is a sudden, brief loss of muscle tone and may be triggered by strong emotions like laughter. Wakix was approved for the expanded cataplexy use October 2020.

Common side effects with Wakix, occurring ≥5% of patients and twice that of placebo, include insomnia (6%), nausea (6%), and anxiety (5%). Sleep disturbances (3%) and hallucinations (3%) have also been reported.

Wakix can lower the effectiveness of some medicines, including hormonal birth control. Patients should use an alternative non-hormonal birth control method during treatment with Wakix and for at least 21 days after discontinuation of treatment. Always have your doctor or pharmacist check for Wakix drug interactions with prescription, over-the-counter, herbal and vitamin medications.

Wakix, from Harmony Biosciences, comes as an oral tablet and is usually taken once daily when you wake up. It may take up to 8 weeks before your symptoms improve. Do not take Wakix if you have severe liver disease. Take your medicine exactly as prescribed by your doctor.

Related: 10 Common Sleep Disorders: Treatments & Truths

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.