Ingrezza (valbenazine) is not a controlled substance. It carries no DEA scheduling designation, meaning it is not classified alongside drugs that have recognized potential for abuse or dependence. You do still need a prescription to get it, but your pharmacy does not need to follow the special tracking, storage, or refill restrictions that apply to controlled substances like opioids or benzodiazepines.
Why Ingrezza Has No DEA Schedule
The DEA assigns drugs to one of five schedules based on their potential for abuse and physical dependence. Ingrezza was never placed on any of these schedules because its chemistry and the way it works in the body don’t match the profile of drugs people misuse. During the FDA review process, the agency’s Controlled Substance Staff evaluated valbenazine and agreed that formal abuse potential studies in humans were unnecessary.
Several factors supported that decision. Valbenazine’s chemical structure is similar to tetrabenazine, an older medication in the same class that has no known history of abuse. The drug works by blocking a specific protein (called VMAT2) that helps package certain brain chemicals for release. It does not bind to the receptor systems typically involved in drug abuse, including opioid receptors, benzodiazepine receptors, and the monoamine transporter systems that stimulants target. Animal studies also showed no behavioral signals of abuse potential.
What the Data Shows on Dependence
While Ingrezza is not considered a drug of abuse, the picture on physical dependence is slightly more nuanced than a simple “no risk.” Dependence and withdrawal were never formally studied in clinical trials. No specific withdrawal questionnaires were used, and the follow-up visits after patients stopped the drug were not frequent enough to reliably catch withdrawal symptoms.
That said, some participants in clinical trials did report symptoms after discontinuation that could suggest mild withdrawal, including anxiety, insomnia, agitation, elevated blood pressure, fatigue, and irritability. The FDA review also noted some signs of tolerance at higher doses and some rebound of symptoms after stopping the drug, both of which can be early indicators of physical dependence. These findings were infrequent and did not rise to the level that would warrant controlled substance classification, but they are worth being aware of if you are considering stopping the medication. Tapering off under your prescriber’s guidance, rather than stopping abruptly, is a reasonable precaution.
What Ingrezza Is Prescribed For
Ingrezza is FDA-approved for the treatment of tardive dyskinesia in adults. Tardive dyskinesia is a movement disorder that causes involuntary, repetitive movements, most often in the face, tongue, and jaw, though it can also affect the limbs and trunk. It typically develops as a side effect of long-term use of certain psychiatric medications, particularly older antipsychotics. Ingrezza was the first drug specifically approved for this condition, receiving FDA clearance in 2017, and its prescribing label was most recently updated in February 2025.
How Prescriptions and Refills Work
Because Ingrezza is not a controlled substance, it follows standard prescription rules. Your doctor can call in or electronically send refills without the extra verification steps required for Schedule II drugs. There are no limits on the number of refills your prescriber can authorize at once, and pharmacies are not required to keep it in a locked cabinet or report dispensing to a state monitoring database.
Ingrezza is commonly dispensed through specialty pharmacies because of its cost and the nature of the condition it treats, not because of any regulatory restriction on handling. Specialty pharmacy distribution is typical for medications that are expensive, require insurance coordination, or treat complex conditions. If your insurance plan routes Ingrezza through a specialty pharmacy, expect a slightly different process than picking up a standard prescription, with possible coordination calls and home delivery, but none of this is related to controlled substance requirements.