Is Wakix a controlled substance?

No, Wakix (pitolisant) is not a controlled substance and it is not classified as a stimulant. Wakix was approved as the first medicine for narcolepsy that is 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 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 classified as controlled substances include:

• Adderall (amphetamine and dextroamphetamine): Schedule 2 (high potential for abuse)
• Lumryz (sodium oxybate): Schedule 3 (moderate 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: What are the controlled substance schedules from the DEA?

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.
• excessive daytime sleepiness in children 6 years of age and older 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 and narcolepsy in children in June 2024.

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 in adults October 2020.

Wakix 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. Take your medicine exactly as prescribed by your doctor.

Wakix is manufactured by Harmony Biosciences.

Related questions

• How does Wakix work for narcolepsy?
• Can you have narcolepsy and insomnia?
• What are the early signs of narcolepsy?

What are the most common side effects with Wakix?

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

In children 6 years of age and older common side effects, in ≥5% of patients and twice that of placebo, include headache (19%) and trouble sleeping (7%).

Important warnings and precautions

Do not take Wakix if you have severe liver disease. Its use is also not recommended in patients with end-stage renal disease (ESRD).

Wakix can cause a change in the electrical activity of the heart known as QT prolongation. Tell your doctor right away if you have a change in your heartbeat, pulse or if you feel dizzy or faint while taking this medicine.

Does Waxix interact with birth control?

Yes, Wakix can lower the effectiveness of some medicines, including birth control that contains hormones (for example: ethinyl estradiol). 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.

Related: Review Wakix drug interactions (in more detail)

This is not all the information you need to know about Wakix (pitolisant) for safe and effective use and does not take the place of your healthcare provider's instructions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.