Pregabalin (Lyrica) is a medication primarily prescribed to manage neuropathic pain, fibromyalgia, certain partial-onset seizures, and generalized anxiety disorder. Because of its effects on the central nervous system, many people ask if pregabalin is considered a controlled substance. The answer is yes; pregabalin is legally classified as a controlled medication in the United States, placing it under specific regulations for prescribing and dispensing.
The Federal Controlled Substance Status of Pregabalin
Pregabalin is designated as a Schedule V controlled substance by the U.S. Drug Enforcement Administration (DEA) under the federal Controlled Substances Act. This classification represents the lowest level of control among scheduled medications, indicating it has a low potential for abuse relative to substances in Schedule IV. The federal government officially placed it in Schedule V in July 2005.
The decision to schedule pregabalin was based on clinical trial data that showed a small percentage of individuals experienced euphoric effects. This potential for positive psychic effects signaled a risk for misuse that warranted regulatory oversight. Schedule V drugs have accepted medical uses and a low, but still present, risk of physical or psychological dependence.
State regulations can sometimes impose stricter controls than federal law. Some states may require prescribers to check a patient’s history in their Prescription Drug Monitoring Program (PDMP) before prescribing any controlled substance, including Schedule V drugs. Patients and prescribers must comply with their individual state’s specific requirements.
Daily Implications for Patients and Prescriptions
The Schedule V designation creates practical requirements that affect both the patient and the prescriber. Obtaining a prescription for pregabalin involves restrictions not typically applied to non-controlled medications. Prescriptions for Schedule V substances are not strictly limited to five refills within a six-month period under federal law, but the prescriber still determines the number of authorized refills.
Pharmacies must meticulously track and document the dispensing of pregabalin, reporting this information to state-level Prescription Drug Monitoring Programs (PDMPs) in most jurisdictions. PDMPs are electronic databases designed to monitor the prescribing and dispensing of controlled substances, helping to identify potential drug-seeking behavior or over-prescribing.
Patients are advised to store pregabalin securely in the home to prevent diversion, which is the transfer of a prescription drug from a lawful user to another person. Because the drug is a federally controlled substance, carrying it during travel, particularly across state lines or internationally, requires caution. It is recommended to keep the medication in its original pharmacy-labeled container, along with a copy of the prescription, to avoid legal complications.
Understanding Pregabalin’s Misuse and Dependence Risk
Pregabalin’s classification as a controlled substance stems from its mechanism of action and the risk of misuse associated with it. The drug works by binding to the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system. This binding action modulates the release of several excitatory neurotransmitters, effectively calming overactive nerve signals that cause pain or seizures.
The potential for misuse exists because, at higher doses, pregabalin can induce feelings of euphoria and relaxation, particularly in individuals with a history of substance use disorder. Misuse is also a concern when pregabalin is taken concurrently with other central nervous system depressants, such as opioids or alcohol, which significantly increases the risk of respiratory depression and sedation.
It is important to distinguish between physical dependence and addiction in the context of pregabalin. Physical dependence, where the body adapts to the presence of the drug, is common with long-term use and requires the medication to be slowly tapered when discontinuing treatment. Addiction, on the other hand, involves a compulsive use of the substance despite harmful consequences, and this risk is considered low for pregabalin when used as prescribed.
If a patient suddenly stops taking pregabalin, they may experience withdrawal symptoms, which is a sign of physical dependence. These symptoms can include insomnia, headache, anxiety, nausea, and excessive sweating. In some cases, particularly in patients treated for seizures, abrupt cessation can lead to a return of seizures, highlighting the necessity of medically supervised dose reduction to safely discontinue the medication.