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Is Wakix a controlled substance?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Feb 9, 2024.

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)

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.

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References

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Although narcolepsy and idiopathic hypersomnia both have excessive daytime sleepiness as a common symptom, people with idiopathic hypersomnia have no sleep-onset rapid eye movement (REM) period, naps are unrefreshing (unlike with narcolepsy) and idiopathic hypersomnia is not associated with cataplexy. Idiopathic hypersomnia can be difficult to distinguish from narcolepsy, but sleep laboratory studies can help differentiate between them. Continue reading

The main test used to help diagnose suspected narcolepsy is an overnight sleep study (called a polysomnogram) followed the next day by the Multiple Sleep Latency Test (MSLT). A polysomnogram records brain waves, eye movements, muscle tone, and breathing across a night of sleep. This evaluates the amount and quality of night-time sleep and can look for any evidence of an additional sleep disorder (such as sleep apnea or periodic limb movements in sleep). The MSLT is a series of five scheduled naps spread across the day and it is done the day after the polysomnogram so a doctor can determine whether the prior night’s sleep could be affecting the daytime naps. Every 2 hours, the person is allowed to sleep for 20 minutes or more. Continue reading

There is no cure for narcolepsy, but medications and lifestyle modifications can help manage symptoms such as excessive daytime sleepiness (EDS). Medications include: stimulants such as modafinil (Provigil) or armodafinil (Nuvigil) are usually tried first for narcolepsy because they are less addictive than older treatments such as methylphenidate (Aptensio XR, Concerta, Ritalin) or various amphetamines; solriamfetol (Sunosi), pitolisant (Wakix); selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine (Prozac, Sarafem) or serotonin and norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine (Effexor XR); tricyclic antidepressants, such as protriptyline (Vivactil), imipramine (Tofranil), and clomipramine (Anafranil); and sodium oxybate (Xyrem). Continue reading

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