Is Fycompa a controlled substance?

Key Points

• Yes, Fycompa is a schedule 3 controlled substance (CIII) first approved in 2012. It is an anticonvulsant used to treat seizures in adults and children.
• Fycompa is classified as a controlled substance by the DEA because it may be habit-forming and lead to abuse or dependence.
• Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Physical dependence occurs due to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or dose reduction.

Fycompa may also make you feel dizzy, sleepy, or tired. Keep this medication in a place where others, including children, family members and pets, cannot get to it.

Avoid drinking alcohol with this medicine. It can increase dizziness or drowsiness and negatively affect your mood.

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

Why is Fycompa prescribed?

Fycompa (generic name: perampanel) is approved to treat partial onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years and older. It is also approved to be used with other medicines to treat primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. It comes as an oral tablet and oral suspension.

Fycompa has central nervous system depressant (CNS) effects like sleepiness and dizziness. You should not drink alcohol or take other CNS depressants with this medicine unless you have spoken to your doctor first. CNS depressants include medicines such benzodiazepines, narcotics, barbiturates, sedating antihistamines, as well as alcohol. If you are not sure if you take any of these medicines, ask your pharmacist or doctor.

In addition to impairing your ability to drive, Fycompa can make your mood worse, and increase levels of anger, confusion and depression when combined with alcohol.

Before you start treatment with Fycompa, tell your doctor:

• if you abuse prescription medicines, street drugs, or alcohol (now or in the past)
• if you drink alcohol now, and how much
• if you have depression, mood problems, aggression, or hostile behavior (for example, homicidal behavior)
• if you have thoughts of suicide or have tried to kill yourself in the past, or have any other psychiatric problems (either now or in the past)
• about all of the medicines you take, including prescription and over-the-counter
  medicines, vitamins, and herbal supplements.

Fycompa carries a Boxed Warning to alert prescribers and patients about the risk of serious nervous system events such as irritability, aggression, anger, anxiety, paranoia (feeling very afraid), euphoric (elevated) mood, agitation (anxiety or nervous excitement), and mental status changes.

Why is Fycompa a controlled substance?

Fycompa is classified as a Schedule 3 controlled substance by the DEA because it may be habit-forming. Misuse of this medicine can cause addiction, overdose, or death. Selling or giving away Fycompa is against the law and may harm others.

In studies conducted by the manufacturer to evaluate the abuse potential of Fycompa, the incidence of euphoria following administration of 8 mg, 24 mg, and 36 mg doses was 37%, 46%, 46%, respectively. When compared, the abuse potential of Fycompa was higher than alprazolam 3 mg (13%) but lower than ketamine 100 mg (89%), two other controlled substances with a high potential for abuse.

Animal studies also demonstrated that Fycompa may cause dependence and withdrawal symptoms that may include anxiety, nervousness, irritability, fatigue, lethargy, asthenia, mood swings, and insomnia.

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

Keep this medication in a place where others, including children, family members, and pets, cannot get to it. Never give your Fycompa to anyone else because it may harm them.

This is not all the information you need to know about Fycompa (perampanel) 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.