Is Xcopri a controlled substance?

Key Points

• Yes, Xcopri is a schedule 5 controlled substance (C-V) first approved in 2019. It is an oral tablet used for the treatment of partial-onset seizures in adult patients with epilepsy.
• Xcopri is classified as a controlled substance by the DEA because it may be habit-forming and lead to abuse or dependence.
• C-V drugs have a lower potential for abuse compared to most other schedules.
• Abuse is intentionally using a drug, even once, for its desirable effects on the mind and body, and not for its medical purpose. Physical dependence occurs due to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or dose reduction.

Xcopri (cenobamate) may also make you feel sleepy, tired, dizzy, affect your steadiness or impair your walking. The most common side effects with Xcopri in studies were somnolence (sleepiness), dizziness, fatigue, diplopia (double vision) and headache.

As with many controlled substances, you should avoid taking this medicine with alcohol or other medicines that can make you sleepy or dizzy without first talking to your healthcare provider. The effects can get worse and may be unsafe. Ask your doctor before using opioid drug, a sleeping pill, a muscle relaxer, or medicine for anxiety with this medicine.

Do not drive, operate heavy machinery or do other dangerous activities until you know how Xcopri affects you.

Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Why is Xcopri a controlled substance?

Xcopri is classified as a CV controlled substance by the DEA because it may be habit-forming and lead to abuse or dependence. Keep this medicine in a safe place where others, including children, family members and pets, cannot get to it. Selling or giving away Xcopri is against the law and may harm others.

Learn more: Controlled Substances Schedules: What do they mean?

The abuse potential of Xcopri 200 mg and 400 mg doses were compared to a placebo (an inactive agent) in studies conducted in people who abused sedatives.

• At the 400 mg dose, subjective responses such as “Drug Liking,” “Overall Drug Liking,” “Take Drug Again,” and “Good Drug Effects” were statistically greater than the responses produced by placebo.
• Euphoric mood (like pleasure, excitement and strong feelings of well-being and happiness) occurred at a greater extent with Xcopri 400 mg (8%) than with placebo (0%).
• In other Xcopri studies in participants with epilepsy, euphoric mood, confusion, and sleepiness occurred at low rates (0.5-2.5%).

Xcopri may lead to withdrawal symptoms and should be gradually discontinued. Insomnia (trouble sleeping), decreased appetite, depressed mood, tremor and amnesia (memory loss) were observed during withdrawal.

Do not stop taking Xcopri without first talking to your healthcare provider. In addition to withdrawal symptoms, abruptly stopping treatment can lead to serious problems like seizures that will not stop (status epilepticus).

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