Pregabalin is a controlled drug because it can produce euphoria and other rewarding psychological effects that make it prone to misuse. In the United States, it sits in Schedule V of the Controlled Substances Act, the lowest tier of control, meaning regulators consider its abuse potential real but limited compared to drugs like benzodiazepines or opioids. Several other countries, including the UK, have also placed restrictions on it for similar reasons.
What the DEA Found Before Scheduling It
When pregabalin was approved for medical use in 2005, the DEA reviewed preclinical and clinical trial data before deciding where to place it. Two findings stood out. First, in animal studies, pregabalin was self-administered at rates higher than a placebo but substantially lower than comparison drugs like sedatives and barbiturates. Second, and more unusually, the percentage of people in clinical trials who reported acute euphoric effects was described as “unusually high” for a drug in this category.
Trial participants also reported dizziness, drowsiness, blurred vision, and concentration problems more often than those taking a placebo. These are the kinds of psychoactive effects that signal a drug could be taken recreationally, not just medically. The DEA concluded that pregabalin produces some effects similar to benzodiazepines like diazepam and alprazolam and “is likely to be abused for its positive psychic effects.”
Still, the data pointed to a ceiling on that risk. Pregabalin didn’t substitute for benzodiazepines in dependent animals, and some of its pleasurable effects appeared to fade with continued use. The DEA characterized it as a drug someone might misuse intermittently for the feeling it produces, rather than one that drives compulsive, escalating use. That distinction is why it landed in Schedule V rather than a higher category.
How Pregabalin Produces Euphoria
Pregabalin works by calming overactive nerve signals in the brain. At therapeutic doses, this helps manage nerve pain, epilepsy, and (in some countries) generalized anxiety disorder. But at higher doses, that same calming action can tip into feelings of relaxation, well-being, and euphoria. Some users describe the sensation as similar to alcohol or benzodiazepine intoxication.
The drug can also amplify the effects of other substances. Combining pregabalin with opioids, for example, intensifies sedation and euphoria. This interaction is part of why it shows up in polydrug misuse patterns, particularly among people already using opioids or benzodiazepines.
Rising Prescriptions, Rising Concern
Pregabalin prescriptions have surged over the past decade. Between 2012 and 2016 alone, U.S. spending on the drug grew from $2 billion to nearly $4.5 billion. By 2022, roughly one in five American adults with chronic pain were taking a gabapentinoid (pregabalin or its close relative gabapentin). Much of that growth came as doctors searched for alternatives to opioids for managing chronic pain.
The wider a drug is prescribed, the more opportunity there is for diversion and misuse. Pregabalin is now commonly used off-label for conditions including generalized anxiety disorder, social anxiety, and even alcohol withdrawal, broadening the population exposed to it. That expanding footprint has kept regulatory attention focused on the drug even years after its initial scheduling.
Dangerous Interactions With Opioids
One of the most serious safety concerns reinforcing pregabalin’s controlled status is its interaction with opioids and other sedating drugs. Taking pregabalin alongside opioids can suppress breathing to a dangerous degree. The combination has been linked to respiratory failure, coma, and death.
Doses above 300 mg per day alongside opioids carry a particularly elevated risk of opioid-related death. In the UK, regulators received 122 reports of respiratory depression associated with pregabalin between 2014 and 2020. Of those, 80 involved a co-administered sedating drug, most commonly opioids, benzodiazepines, or gabapentin. The FDA issued its own warning in 2019 about the respiratory depression risk when pregabalin is combined with other central nervous system depressants.
Dependence and Withdrawal
Pregabalin can cause physical dependence, meaning the body adapts to its presence and reacts when the drug is removed. This is another core reason it carries controlled status. Withdrawal symptoms typically begin within 24 hours of the last dose and can include insomnia, nausea, headaches, anxiety, sweating, restlessness, and an increased heart rate. These acute symptoms usually peak within a few days and resolve within about a week, though lingering effects like mood swings, fatigue, and disrupted sleep can persist for several weeks.
In more severe cases, abrupt discontinuation has triggered seizures and suicidal thoughts. This is why prescribers taper the dose gradually rather than stopping the drug all at once. The withdrawal profile is milder than that of Schedule IV substances like benzodiazepines, which is consistent with its lower scheduling tier, but it is real enough to warrant caution and medical supervision when stopping.
How Scheduling Affects You in Practice
Schedule V is the least restrictive controlled substance category in the U.S. In practical terms, this means pregabalin requires a prescription (it cannot be sold over the counter), refills may be limited depending on state law, and pharmacies track dispensing. Doctors can still prescribe it freely, but the controlled label serves as a signal to monitor patients for signs of misuse, especially those with a history of substance use disorders.
In the UK, pregabalin was reclassified as a Class C controlled substance in 2019, a step that reflected growing evidence of misuse and pregabalin-related deaths in that country. The reclassification added tighter prescribing rules, including limits on repeat prescriptions. Other countries have taken similar steps as post-marketing data confirmed the abuse patterns regulators initially flagged during clinical trials.