Yes, Fycompa (perampanel) is a Schedule III controlled substance in the United States. The DEA placed it in this category effective January 2, 2014, based on evidence that the drug can produce euphoria, has potential for abuse, and causes withdrawal symptoms when discontinued. This classification affects how the medication is prescribed, dispensed, and refilled.
Why Fycompa Is Classified as Schedule III
Fycompa works by blocking a specific type of receptor in the brain that responds to glutamate, the main chemical signal responsible for exciting nerve cells. By dampening this excitatory signaling, the drug reduces the overactive brain activity that causes seizures. But this same mechanism also produces effects that raise abuse concerns.
In clinical abuse-potential studies, 46% of subjects who received higher doses of perampanel (24 and 36 mg) reported euphoria, a rate higher than the 13% seen with alprazolam (a well-known benzodiazepine) but lower than the 89% seen with ketamine. Even at 8 mg, which is within the therapeutic dosing range, 37% of subjects experienced euphoria. The DEA concluded that perampanel produces euphoria comparable to both alprazolam and ketamine, two drugs already recognized for their abuse potential.
Schedule III sits in the middle of the DEA’s five-tier system. It indicates a moderate-to-low potential for physical and psychological dependence, less than Schedule II drugs like oxycodone but more than Schedule IV drugs like most sleep medications. Other well-known Schedule III substances include testosterone and certain combination products containing codeine.
Withdrawal Symptoms After Stopping
Part of what cemented perampanel’s controlled status was evidence of physical dependence. When patients in Phase 3 clinical trials stopped taking the drug, a range of withdrawal symptoms emerged: fatigue, irritability, anxiety, insomnia, mood swings, changes in appetite and weight, gastrointestinal problems like nausea and diarrhea, muscle pain, headache, dizziness, and in some cases hallucinations, panic, and drug-seeking behavior. The Department of Health and Human Services reviewed this data and concluded that discontinuing perampanel does cause clinically meaningful withdrawal.
This is one reason why Fycompa is typically tapered gradually rather than stopped abruptly. If you’re considering stopping the medication, your prescriber will usually step the dose down over time to minimize these effects.
What Schedule III Means for Your Prescription
Because Fycompa is Schedule III, federal law places specific limits on how it can be prescribed and refilled. Your prescription can be refilled up to five times, but only within six months of the date it was originally written. After six months or five refills, whichever comes first, you need a new prescription. Unlike Schedule II drugs, Fycompa prescriptions can be called in or sent electronically to a pharmacy, which makes the refill process somewhat more convenient.
Partial fills are also allowed, as long as all dispensing happens within that same six-month window. If your pharmacy doesn’t have your full quantity in stock, they can give you a partial supply and provide the rest later without requiring a new prescription.
Boxed Warning for Psychiatric Reactions
Separate from its controlled substance classification, Fycompa carries an FDA boxed warning for serious psychiatric and behavioral reactions. These include aggression, hostility, irritability, anger, and in rare cases homicidal ideation and threats. These reactions have occurred in patients with no prior psychiatric history, which means they aren’t limited to people already at risk.
The risk is highest during dose increases and at higher doses. If you or someone around you notices unusual changes in mood, personality, or behavior while taking Fycompa, that warrants prompt contact with a healthcare provider. In severe cases, the drug is discontinued immediately rather than tapered.
Generic Availability
As of the most recent FDA records, a generic version of perampanel tablets (in all strengths from 2 mg to 12 mg) received tentative approval in 2022 but has not yet reached the market due to patent protections. This means Fycompa remains available only as the brand-name product from Eisai. When a generic does eventually launch, it will carry the same Schedule III classification and the same prescribing restrictions as the brand version.