Article: America's Fifth Most Prescribed Drug Was Never Approved for What Most People Take It For
America's Fifth Most Prescribed Drug Was Never Approved for What Most People Take It For
The Failed System · Educational
America's Fifth Most Prescribed Drug Was Never Approved for What Most People Take It For
Gabapentin was approved in 1993 for seizures. Three decades later it is one of the most prescribed medications in the country, and most of that prescribing is for something else entirely. Its rise says less about one drug and more about how many patients are still searching for supervised options.
01The quiet rise of a seizure drug
Gabapentin entered the market in 1993 with a narrow job: adjunctive treatment for partial seizures. Its FDA approvals have stayed narrow ever since. Partial seizures. Postherpetic neuralgia, the nerve pain that can follow shingles. And, in an extended-release form, restless legs syndrome.
Its prescribing did not stay narrow. Gabapentin has climbed into the ranks of the most prescribed medications in the United States, with recent reporting placing it fifth in the country. Tens of millions of prescriptions are written every year. Almost none of that growth came from seizures.
The gap in one sentence
One of America's most prescribed medications is used, most of the time, for conditions it was never approved to treat.
02What it is actually prescribed for
Ask what gabapentin is used for in practice and the list looks very different from its label: anxiety, sleep difficulty, nerve-related pain beyond its approved indication, migraine prevention. Published analyses have estimated that the large majority of gabapentin prescribing is off-label.
One thing should be said plainly. Off-label prescribing is legal, common, and often clinically reasonable. Physicians are permitted to use their judgment when approved options have not worked for an individual patient. This article is not an indictment of off-label medicine or of the clinicians who practice it carefully. It is an examination of what this particular pattern reveals.
03What the pattern reveals: demand the system never met
A drug does not become a top-five prescription on the strength of its approved uses when those uses are this narrow. It gets there because an enormous population of patients is struggling with anxiety, sleep, and pain, because first-line options do not work for everyone, and because physicians reach for whatever supervised tool exists when a patient is still suffering.
That is the real story of gabapentin's rise. The demand was never in question. The options were.
Patients accepted an imperfect, off-label medication at national scale for one reason: a licensed clinician was involved. There was an evaluation, a prescription, a pharmacy, and someone accountable for the decision. Structure is what patients were buying. The molecule came second.
04The side effect record, stated factually
Every prescription medication carries a side effect profile, and gabapentin's is documented. The commonly reported effects include drowsiness, dizziness, fatigue, cognitive fog, and swelling in the extremities.
Two entries in the record deserve specific attention.
First, in December 2019 the FDA issued a Drug Safety Communication warning that gabapentinoids can cause serious breathing difficulties in patients who use opioids or other central nervous system depressants, and in patients with existing respiratory risk factors, including older adults.
Second, stopping gabapentin abruptly can produce withdrawal symptoms, including agitation, insomnia, and anxiety, and in seizure patients it can raise seizure risk. Discontinuation is a clinical process, not a personal decision. No one taking gabapentin should stop or change it without their prescriber.
Beyond the documented record, some patients have reported hearing changes, including tinnitus. These reports appear in patient communities and adverse event reporting rather than in controlled trials, and a causal relationship is not established. We note them here as what they are: patient reports that belong in an honest accounting, stated at the strength of the evidence and no stronger.
05The pattern beneath the drug
Gabapentin is not the first medication to carry weight it was never designed for. Benzodiazepines were studied for short-term use and became long-term prescriptions for millions. Chronic pain patients lost access to one supervised option and were often handed another with its own unresolved questions. Each time, the underlying condition of the system is the same: for the overlapping concerns of anxiety, pain, and sleep, patients cycle through whatever supervised tools exist, because for decades the set of supervised tools barely grew.
That is a system-level observation, not a criticism of any drug or any prescriber. The drugs did the job the system asked of them. The question worth asking is why the system had so few answers to offer.
06The part that changed
What patients demonstrated through three decades of gabapentin prescribing is that they will choose clinical structure when it is offered: a licensed clinician, an individual evaluation, a real prescription, a licensed pharmacy. That structure now exists for cannabinoid therapy. It is what Prescription Cannabinoid Care is: a clinical pathway in which a licensed clinician evaluates an individual patient's health history and complete current medication list before determining whether prescription cannabinoid therapy is appropriate for that person.
A thorough evaluation looks at the whole picture, including every medication a patient currently takes and how the pieces fit together. Whether the primary concern is anxiety, pain, or sleep, the process begins the same way: an individual evaluation with a licensed clinician. You can read exactly how the evaluation process works before deciding whether to begin.
At Cope Now
The starting point is never a product. It is a clinical evaluation with a licensed clinician who reviews your history and your current medications before anything else happens.
Frequently asked questions
Is gabapentin FDA-approved for anxiety?
No. Gabapentin's FDA approvals cover partial seizures as adjunctive therapy, postherpetic neuralgia, and, in its extended-release form, restless legs syndrome. Prescribing for anxiety is off-label, meaning a clinician has determined it may be appropriate for an individual patient outside the approved indications. Off-label prescribing is legal and common in the United States.
What is gabapentin most commonly prescribed for?
Beyond its approved uses, gabapentin is widely prescribed off-label for concerns including anxiety, sleep difficulty, nerve-related pain outside its approved indication, and migraine prevention. Published analyses have estimated that the majority of gabapentin prescribing in the United States is off-label.
What side effects have been reported with gabapentin?
Commonly documented side effects include drowsiness, dizziness, fatigue, and swelling in the extremities. In 2019 the FDA issued a warning about serious breathing difficulties when gabapentinoids are used with opioids or other central nervous system depressants, or in patients with respiratory risk factors. Some patients have also reported hearing changes, including tinnitus, though a causal relationship is not established. Any side effect concerns should be discussed with the prescribing clinician.
Can I stop taking gabapentin on my own?
No. Stopping gabapentin abruptly can cause withdrawal symptoms, and in patients taking it for seizures it can increase seizure risk. Any change to gabapentin, including tapering or discontinuing, should be made only under the guidance of the prescribing clinician.
What this article does and does not mean
This article describes documented facts about gabapentin prescribing patterns and its published safety record, and it examines what those patterns reveal about patient demand. It does not compare cannabinoid therapy to gabapentin or any other medication, does not claim cannabinoid therapy is a substitute or alternative for any medication, and does not claim that CBD or any cannabinoid treats, cures, or prevents any condition. It is not medical advice. Never stop, start, or change any prescription medication without the guidance of your prescribing clinician. Whether prescription cannabinoid therapy is appropriate for any individual is a determination only a licensed clinician can make following an individual evaluation. Not all patients are eligible.
Selected References
- U.S. Food and Drug Administration. FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR). Drug Safety Communication. December 2019.
- Goodman CW, Brett AS. Gabapentin and pregabalin for pain: is increased prescribing a cause for concern? New England Journal of Medicine. 2017.
- ClinCalc DrugStats Database. Top prescribed medications in the United States, most recent available year.
- Mersfelder TL, Nichols WH. Gabapentin: abuse, dependence, and withdrawal. Annals of Pharmacotherapy. 2016.
- Neurontin (gabapentin) full prescribing information. U.S. Food and Drug Administration label.
- Men's Health. Does America's new favorite anxiety drug have a dark side? 2025.


Leave a comment
This site is protected by hCaptcha and the hCaptcha Privacy Policy and Terms of Service apply.