Pregabalin is a controlled substance because it produces euphoria and other pleasurable effects at rates high enough to raise concern about misuse. In the United States, the DEA placed it in Schedule V in 2005, the lowest tier of controlled substances, after clinical trial data showed that 4% of patients reported euphoria (compared to 1% on placebo), with rates as high as 12% in some patient groups. That classification reflects a drug with recognized medical value but a real, if relatively low, potential for abuse and dependence.
The DEA’s Three-Part Justification
When the DEA scheduled pregabalin, it applied three criteria from the Controlled Substances Act. First, pregabalin has a low potential for abuse relative to drugs in Schedule IV (which includes benzodiazepines like alprazolam and lorazepam). Second, it has accepted medical uses in the U.S., primarily for nerve pain, fibromyalgia, and certain seizure disorders. Third, misuse of pregabalin may lead to limited physical or psychological dependence compared to Schedule IV drugs.
The word “limited” is doing important work in that third criterion. Pregabalin’s withdrawal effects are less severe than those of benzodiazepines and other Schedule IV substances. Its positive mental effects also appear to fade with continued use rather than deepening, which makes sustained compulsive use less likely than with drugs higher on the schedule.
What Makes It Feel Good
In a study of 15 recreational drug users, a single 450 mg dose of pregabalin produced ratings of “good drug effect,” “high,” and “liking” similar to a 30 mg dose of diazepam (Valium). The DEA noted that the percentage of people experiencing euphoria in clinical trials was “unusually high” for a drug of this type. That feeling of calm, pleasant sedation is the core reason pregabalin attracts misuse.
What’s unusual is that pregabalin doesn’t work like most drugs of abuse at the molecular level. It doesn’t bind to opioid receptors, benzodiazepine receptors, or any of the receptor types typically associated with addictive drugs. It also doesn’t increase dopamine in the brain’s reward center the way opioids do. In animal studies, pregabalin actually blocked the dopamine surge caused by morphine. Its mechanism of action, which involves binding to a specific subunit of calcium channels on nerve cells, isn’t fully understood in terms of why it produces euphoria at all.
The DEA described the data as “consistent with a substance that could be abused intermittently for reward, but not for reinforcement.” In plain terms, people might take it recreationally to feel good in the moment, but it’s less likely to create the escalating cycle of craving and compulsion seen with stronger controlled substances.
Withdrawal and Physical Dependence
Physical dependence does develop with regular use. When patients stop pregabalin abruptly, reported withdrawal symptoms include insomnia, nausea, headache, anxiety, diarrhea, and excessive sweating. The FDA label recommends tapering the drug gradually over at least one week rather than stopping suddenly.
In clinical studies of patients with generalized anxiety disorder, about a third of those on pregabalin reported discontinuation symptoms during the two weeks after tapering began, regardless of whether they were on a higher dose (450 to 600 mg daily) or a lower one (150 to 300 mg daily). That rate was essentially identical to the rate seen in patients tapering off lorazepam, a benzodiazepine. However, rebound anxiety, where anxiety spikes worse than it was before treatment, was low across all groups, ranging from 0% to 6%. Researchers concluded that a one-week taper was sufficient to avoid clinically meaningful withdrawal problems after up to 24 weeks of use.
Why Pregabalin but Not Gabapentin
Gabapentin, pregabalin’s close relative, is not a federally controlled substance in the U.S. (though some states have added their own restrictions). The difference comes down to how the two drugs behave in the body. Pregabalin is absorbed more completely and predictably than gabapentin, which means higher doses reliably produce stronger effects. Gabapentin’s absorption plateaus at higher doses, making it harder to get a concentrated “hit.” Research has found that pregabalin has greater addiction potential based on the severity of dependence symptoms, the likelihood that patients transition from prescribed use to self-directed use, and how long that self-directed use persists.
Both drugs can produce similar psychoactive effects, including sedation and a dissociative, almost psychedelic quality at high doses. But pregabalin’s more efficient pharmacology makes it easier to misuse effectively, which is why regulators treated the two differently.
The Danger With Opioids and Sedatives
The most serious safety concern with pregabalin misuse involves combining it with opioids or other sedating drugs. The UK’s drug safety agency has documented cases of respiratory failure, coma, and death when pregabalin is co-ingested with central nervous system depressants. Doses above 300 mg per day alongside opioids are particularly associated with an increased risk of opioid-related death. In a UK review of 122 cases of severe respiratory depression linked to pregabalin, 80 involved a co-administered depressant such as an opioid, benzodiazepine, or gabapentin.
This interaction is a major reason regulators have tightened controls. People who misuse pregabalin often already use other substances, and the combination amplifies breathing suppression in a way that neither drug would cause alone at the same dose.
Stricter Controls in Other Countries
The U.S. Schedule V classification is actually one of the more lenient approaches globally. The UK reclassified both pregabalin and gabapentin as Schedule 3 controlled drugs in April 2019, a stricter category that imposes tighter prescribing and record-keeping requirements. That move was driven by rising misuse and a growing number of deaths involving gabapentinoids.
European data illustrates the scale of non-medical use. A 2017 survey across five countries found that roughly 1 in 1,000 adults in Germany and the UK had used gabapentinoids non-medically in the previous 90 days. Among people in Spain who had ever been prescribed pregabalin, about one in five reported using it in ways not directed by their doctor. Most obtained the drug through legitimate prescriptions, but significant numbers also acquired it from family, friends, online sources, or dealers.
Street prices in the European survey were modest (around 10 euros), and some users reported injecting the drug, though this was more common with gabapentin (41% of those using it to get high) than pregabalin (14.3%). The accessibility and low cost have contributed to pregabalin becoming one of the more commonly diverted prescription medications in parts of Europe and the Middle East.
What Schedule V Means in Practice
For patients in the U.S., Schedule V is the least restrictive controlled substance category. Your pharmacy keeps records of the prescription, and refills may require a new prescription depending on state law, but it carries none of the tight limits associated with Schedule II drugs like oxycodone. You won’t face the same refill restrictions or quantity limits. The main practical impact is that prescribers are expected to screen for a history of substance use and monitor for signs of misuse such as dose escalation or drug-seeking behavior. Transferring prescriptions between pharmacies may also involve additional steps compared to uncontrolled medications.