Is Vraylar (cariprazine) a controlled substance?
Vraylar (cariprazine) is not classified as a controlled substance.
It is an atypical antipsychotic used to treat::
- Schizophrenia
- Acute manic or mixed episodes in bipolar I disorder
- Depressive episodes in bipolar I disorder
- Major depressive disorder (as an add-on to antidepressants)
Why Might People Think Vraylar Is a Controlled Drug?
Vraylar may help reduce substance abuse in individuals with bipolar I disorder. Since substance use disorders are sometimes treated with controlled substances (e.g., methadone) and are common in people with bipolar I disorder or schizophrenia, there may be confusion about Vraylar’s classification.
What Is a Controlled Substance? DEA Criteria Explained
Controlled substances are regulated by the U.S. Drug Enforcement Administration (DEA) under the Controlled Substances Act (CSA). Drugs are classified into one of five schedules based on their potential for abuse, accepted medical use, and safety profile. Schedule I drugs have the highest abuse risk and no medical use; Schedules II–V have recognized medical uses but varying degrees of risk and dependence potential. Drugs like opioids and certain stimulants are scheduled due to these risks.
- Schedule I: High potential for abuse, no accepted medical use (e.g., heroin).
- Schedule II-V: Varying degrees of abuse potential, with accepted medical uses (e.g., opioids, stimulants, sedatives).
Vraylar (cariprazine) is not classified as a controlled substance, as it does not pose significant abuse or dependence risk according to scientific evidence and FDA review.
Why Is Vraylar Not Scheduled as a Controlled Drug?
Vraylar is an atypical antipsychotic, approved for schizophrenia, bipolar I disorder (mania, depression, mixed episodes), and as adjunctive treatment in major depressive disorder. FDA prescribing information clearly states Vraylar is not a controlled substance and has not shown signs of abuse or dependence in studies or clinical practice.
Most drugs scheduled by the DEA either produce euphoria, have a history of abuse, or are linked to physiological dependence. In contrast, Vraylar’s pharmacological effects do not result in a “high,” and it does not trigger cravings or withdrawal seen with addictive drugs.
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Abuse and Dependence Potential: Scientific Evidence
Clinical research shows that cariprazine does not possess significant abuse liability. Animal studies indicate a lack of reward-seeking behavior, and patient reports in long-term studies confirm no evidence of abuse or physical dependence. In fact, cariprazine’s unique partial agonism at dopamine D3 receptors may help reduce reward-seeking and craving in people with substance use disorders.
Early-phase studies suggest cariprazine could benefit individuals living with both bipolar disorder and substance use disorders (SUD), potentially reducing cravings and substance use. However, larger clinical trials are needed to confirm these benefits.
Vraylar’s Safety: Boxed Warnings vs. Controlled Drug Risks
Although Vraylar is not scheduled, it does carry FDA boxed warnings about increased risk of death in elderly patients with dementia-related psychosis and the risk of suicidality in young adults and children. These warnings do not relate to abuse or dependence, but rather highlight important safety precautions for prescribing Vraylar.
- Risk of suicidal thoughts and behaviors—especially in patients 24 and under.
- Increased mortality for elderly with dementia-related psychosis: Antipsychotics (including Vraylar) should not be used for this population.
FDA guidance stresses that these risks should be carefully weighed but are not associated with Vraylar being a controlled substance.
References
- Csehi, R., Dombi, Z. B., Sebe, B., & Molnár, M. J. (2022). Real-Life Clinical Experience With Cariprazine: A Systematic Review of Case Studies. Frontiers in Psychiatry, 13, Article 827744. https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.827744/full
- Food and Drug Administration (FDA). Vraylar. Highlights of Prescribing Information. [Accessed December 22, 2022]. Available online at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204370s009lbl.pdf
- Sanders LO, Miller JJ. Cariprazine May Decrease Substance Abuse in Patients with Bipolar I Disorders. Psychiatric Times. March 15, 2019. Vol 36, Issue 3. Available online at: https://www.psychiatrictimes.com/view/cariprazine-may-decrease-substance-abuse-patients-bipolar-i-disorder.
- Román, V., Gyertyán, I., Sághy, K., Kiss, B., & Szombathelyi, Z. (2013). Cariprazine (RGH-188), a D₃-preferring dopamine D₃/D₂ receptor partial agonist antipsychotic candidate demonstrates anti-abuse potential in rats. Psychopharmacology, 226(2), 285–293. https://doi.org/10.1007/s00213-012-2906-7
- Thoma P, Daum I. Comorbid substance use disorder in schizophrenia: A selective overview of neurobiological and cognitive underpinnings. Psychiatry and Clinical Neurosciences 2013; 67: 367–383. doi:10.1111/pcn.12072.
- United States Drug Enforcement Administration (DEA). Drug Scheduling. Controlled Substances. May 5. 2020. [Accessed February 2, 2021]. Available online at: https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf
- United States Drug Enforcement Administration (DEA). Drug Scheduling. [Accessed July 21, 2020]. Available online at: https://www.dea.gov/drug-scheduling.
Read next
How long does it take for Vraylar (cariprazine) to work?
Vraylar (cariprazine) takes time to work and patients often see a gradual reduction in symptoms over several weeks. Symptoms tend to continue to improve the longer the medication is taken. Continue reading
How does Vraylar compare with Seroquel?
Vraylar and Seroquel are both oral prescription medicines known as atypical antipsychotics. They treat the mental health conditions schizophrenia and bipolar disorder. Vraylar is also approved to treat Major Depressive Disorder (MDD). They work by changing the actions of chemicals in your brain to help stabilize thoughts, actions and moods. Continue reading
Do Vraylar (cariprazine) side effects go away?
Most side effects with Vraylar will subside with time after your body has become used to the medicine. However, some side effects can be serious, have long-lasting effects or be irreversible. Speak to your doctor for medical advice if you have side effects that concern you with Vraylar or any other medication.
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