Prescribed off-label sits at the center of this dementia and brain health question.
Gabapentin — sold under the brand name Neurontin — is prescribed off-label more than any other drug in America, and it is not even close. Up to 95% of gabapentin prescriptions are written for conditions the FDA never approved it to treat, including chronic pain, fibromyalgia, migraines, anxiety, bipolar disorder, and alcohol withdrawal. The drug was approved in 1993 for just two narrow uses: as an add-on therapy for partial seizures in epilepsy and for postherpetic neuralgia, the nerve pain that lingers after a shingles outbreak. Nearly everything else doctors prescribe it for falls outside those boundaries.
What makes this especially relevant for families dealing with dementia and cognitive decline is that older adults are gabapentin’s heaviest users. In 2024, more than 114 out of every 1,000 Americans aged 65 and older were prescribed the drug — the same population most vulnerable to its sedating side effects and most likely to already be managing multiple medications. If someone you care for has been handed a gabapentin prescription, there is a good chance it was written for a purpose the FDA never evaluated. This article covers how gabapentin became the fifth most prescribed drug in the country, the billion-dollar fraud scandal that fueled its off-label spread, the safety concerns that matter most for aging brains, and what caregivers should ask before accepting that prescription.
Table of Contents
- Why Is Gabapentin Prescribed Off-Label More Than Any Other Drug in America?
- The Pfizer Marketing Scandal That Seeded Gabapentin’s Off-Label Empire
- What Gabapentin Does to Aging Brains and Why Caregivers Should Pay Attention
- What to Ask Before Accepting a Gabapentin Prescription for an Older Adult
- The Safety Signals Piling Up Around Gabapentin
- How Off-Label Prescribing Became Normal in American Medicine
- Where Gabapentin Prescribing Goes From Here
- Conclusion
- Frequently Asked Questions
Why Is Gabapentin Prescribed Off-Label More Than Any Other Drug in America?
The short answer is a combination of the opioid crisis, aggressive pharmaceutical marketing, and a medical culture that runs on word of mouth. When prescribing opioids became professionally and legally risky in the mid-2010s, clinicians scrambled for alternatives. Gabapentin looked attractive — it was cheap, generic, widely available, and perceived as non-addictive. doctors began reaching for it to treat everything from lower back pain to anxiety to insomnia. According to data published in the Annals of Internal Medicine in September 2025, gabapentin prescriptions nearly tripled from roughly 24 million in 2010 to nearly 59 million in 2024. The number of individual Americans prescribed the drug jumped from 5.8 million to 15.5 million in the same period. What is striking is how little formal evidence supports many of these uses.
A study published in the journal BMC Health Services Research found that prescribers are often unaware of gabapentin’s limited FDA-approved indications. Decisions to prescribe it off-label are frequently guided by informal colleague discussion rather than systematic evidence evaluation — a doctor hears from a colleague that gabapentin worked well for a patient’s nerve pain, and the practice spreads. Compare gabapentin’s roughly 95% off-label rate to quetiapine (Seroquel), which has about 76% off-label use, or to the national average across all drugs, where about 1 in 5 prescriptions are off-label. Gabapentin is in a category by itself. For context, off-label prescribing is legal and sometimes medically justified. Physicians are allowed to prescribe any FDA-approved drug for any condition if they believe it will help. The problem arises when the evidence base is thin, the risks are poorly understood in specific populations, and the patient — often an older adult with cognitive concerns — is never told the prescription is off-label in the first place.
The Pfizer Marketing Scandal That Seeded Gabapentin’s Off-Label Empire
Gabapentin’s dominance did not happen by accident. It was engineered. In 2004, Warner-Lambert — a Pfizer subsidiary — paid $430 million to settle charges that it had illegally promoted Neurontin for bipolar disorder, ADHD, migraines, and pain conditions, none of which were FDA-approved uses. At the time, this was the largest pharmaceutical settlement under the False Claims Act in U.S. history. The company did not stop there, and neither did the consequences. Pfizer later paid an additional $325 million to settle claims that its Parke-Davis unit had promoted Neurontin for unapproved uses, costing healthcare payers millions of dollars. The total Neurontin settlement tally reached $945 million. A separate $190 million settlement resolved antitrust claims related to blocking generic competitors from entering the market.
Then in 2009, Pfizer paid the U.S. Department of Justice $2.3 billion in a broader settlement that included Neurontin off-label marketing violations. In 2010, a jury awarded $142 million in damages against Pfizer in yet another Neurontin lawsuit. Added together, the legal and financial fallout exceeded $3 billion. However, here is the part that matters most: the marketing worked. Even after the settlements, the prescribing habits Warner-Lambert cultivated in the late 1990s and early 2000s had already taken root. Doctors who had been educated — through industry-funded dinners, sponsored continuing education, and paid opinion leaders — to think of gabapentin as a versatile tool for pain and mood disorders continued prescribing it that way. The fines were a cost of doing business. The off-label market had been permanently expanded. If your loved one is taking gabapentin today for chronic pain or mood issues, the origin of that prescribing pattern traces directly back to a campaign the federal government proved was fraudulent.
What Gabapentin Does to Aging Brains and Why Caregivers Should Pay Attention
For families navigating dementia or mild cognitive impairment, gabapentin deserves special scrutiny. The drug works by modulating calcium channels in the nervous system, which dampens nerve signaling. In practical terms, that means sedation, dizziness, and cognitive slowing — side effects that may be tolerable in a younger patient but can be devastating for someone whose brain is already compromised. Consider a specific scenario that plays out in memory care facilities regularly: an 80-year-old woman with moderate Alzheimer’s disease develops chronic leg pain. Her doctor prescribes gabapentin because it seems safer than an opioid. Within weeks, her family notices she is more confused, unsteady on her feet, and sleeping far more than usual. They assume the dementia is progressing.
In reality, the gabapentin is layering sedation on top of an already fragile neurological state. Falls increase. Confusion deepens. And because nobody connected the dots, the prescription continues for months. The prescribing data confirms this is not a rare situation. Older adults aged 65 and above use gabapentin at the highest rate of any age group — more than 114 per 1,000 persons in 2024. Advanced practitioner prescribing of gabapentin surged from 2.5 per 1,000 persons in 2010 to 19.5 per 1,000 in 2024, meaning nurse practitioners and physician assistants in settings like nursing homes and urgent care clinics are writing these prescriptions at nearly eight times the previous rate. That growth is not necessarily a problem on its own, but it does raise questions about whether the unique risks for cognitively impaired older adults are being adequately considered.
What to Ask Before Accepting a Gabapentin Prescription for an Older Adult
The most important question a caregiver can ask is deceptively simple: “Is this on-label or off-label, and what is the evidence for using it in this specific situation?” If the answer is that gabapentin is being prescribed off-label — which, statistically, it almost certainly is — the follow-up question should be whether alternatives with stronger evidence have been considered first. For nerve pain specifically, gabapentin does have FDA approval for postherpetic neuralgia, so that use is on solid regulatory ground. But for general chronic pain, fibromyalgia, anxiety, or sleep problems, the picture is murkier. Physical therapy, cognitive behavioral therapy for pain, topical treatments like lidocaine patches, or even carefully monitored low-dose medications with better evidence profiles may be worth discussing.
The tradeoff is real: gabapentin is convenient and inexpensive, and switching to alternatives may require more appointments, more monitoring, or higher costs. But for a patient already dealing with cognitive decline, the risk of additional brain fog and falls may tip that calculation. Ask the prescriber to specifically address what monitoring plan is in place, what side effects to watch for, and at what point the medication should be reconsidered. Too many gabapentin prescriptions are written and never revisited — the drug just becomes a permanent part of the medication list, accumulating risk without ongoing evaluation.
The Safety Signals Piling Up Around Gabapentin
The perception that gabapentin is a safe, non-addictive alternative to opioids has taken serious hits in recent years. Research has shown that patients prescribed gabapentin have significantly higher rates of diagnosed substance use disorder and are more likely to also be prescribed opioids compared with non-users. This overlap is not coincidental — gabapentin can enhance the euphoric effects of opioids, which is why some patients and people who misuse drugs seek it out. The numbers on overlapping prescriptions are stark. Co-prescribing of opioids and gabapentin increased 344% between 2006 and 2018, rising from 1.9% to 7.6% of relevant prescriptions.
That combination carries real danger: both drug classes suppress breathing, and together they increase the risk of fatal respiratory depression. Multiple states have responded by classifying gabapentin as a “drug of concern” and adding it to prescription drug monitoring programs — the same tracking systems originally built to flag opioid misuse. For dementia caregivers, the practical warning is this: if your loved one is taking both an opioid and gabapentin, that combination should be flagged with every provider involved in their care. Do not assume that because gabapentin is not a controlled substance at the federal level it is free of interaction risks. And if a new provider prescribes gabapentin without checking the full medication list, treat that as a red flag about the thoroughness of the evaluation.
How Off-Label Prescribing Became Normal in American Medicine
Gabapentin is the most extreme example, but it is far from the only drug routinely prescribed off-label. According to the Agency for Healthcare Research and Quality, off-label prescribing rates across all medications increased from 29.9% in 1993 to 38.3% by 2008 — nearly four out of ten prescriptions. The practice is legal, and in many cases it fills genuine gaps where FDA trials have not caught up with clinical experience.
Oncology, for instance, relies heavily on off-label use because cancer subtypes change faster than the drug approval process can follow. The problem is not off-label prescribing itself but the absence of guardrails. When gabapentin is prescribed off-label to a 75-year-old for generalized anxiety, there is no requirement that the patient be told the use is off-label, no mandate for the prescriber to document the evidence supporting that choice, and no system to track whether it is helping or causing harm. For families managing a loved one’s dementia care, understanding that a prescription may be off-label is the first step toward asking better questions and pushing for more thoughtful medication management.
Where Gabapentin Prescribing Goes From Here
The trajectory is unlikely to reverse quickly. With nearly 59 million prescriptions dispensed in 2024 and gabapentin now ranked as the fifth most prescribed drug in the country, it is deeply embedded in American medical practice. However, the growing body of safety data, the addition of gabapentin to state monitoring programs, and increasing awareness among patients and caregivers may slow the climb.
What would genuinely change the landscape is a requirement for informed consent around off-label prescribing — telling patients when a drug is being used outside its approved indications and what evidence supports that choice. For the dementia and brain health community, the practical step is simpler: review every medication on your loved one’s list, ask whether each one is on-label or off-label, and insist on a clear justification for anything that might be adding to cognitive burden. The drug that was supposed to be the safe alternative deserves a harder look.
Conclusion
Gabapentin’s rise from a niche epilepsy drug to the fifth most prescribed medication in America is a story about marketing, the opioid crisis, and a medical system that often defaults to convenience over evidence. With up to 95% of its prescriptions written off-label and older adults bearing the heaviest prescribing burden, the drug sits at the intersection of nearly every concern that matters to dementia caregivers — cognitive side effects, fall risk, polypharmacy, and inadequate monitoring. None of this means gabapentin is never appropriate.
For its FDA-approved indications and in carefully selected patients, it can provide genuine relief. But the sheer scale of off-label prescribing — driven in part by a marketing campaign the federal government proved was illegal — demands that caregivers, patients, and families stop treating a gabapentin prescription as routine. Ask what it is for, whether it is on-label, what the alternatives are, and how it will be monitored. A drug prescribed to 15.5 million Americans deserves at least that much scrutiny.
Frequently Asked Questions
Is gabapentin addictive?
Gabapentin is not classified as a controlled substance at the federal level, but evidence shows patients prescribed gabapentin have significantly higher rates of substance use disorder. Multiple states have added it to prescription drug monitoring programs due to misuse concerns, particularly when combined with opioids. It can produce physical dependence, and abrupt discontinuation can cause withdrawal symptoms including seizures.
Can gabapentin worsen dementia symptoms?
Gabapentin’s sedating effects — including drowsiness, dizziness, and cognitive slowing — can mimic or worsen dementia symptoms. In older adults with existing cognitive impairment, these side effects may be mistaken for disease progression rather than recognized as medication-related. Any new or worsening confusion after starting gabapentin should be reported to the prescribing physician immediately.
Is off-label prescribing legal?
Yes. Once a drug is FDA-approved for any indication, licensed physicians are permitted to prescribe it for any condition they believe it may help. What is illegal is for pharmaceutical companies to market or promote drugs for off-label uses, which is exactly what Pfizer’s subsidiary did with Neurontin, resulting in settlements exceeding $945 million.
Should I stop my loved one’s gabapentin immediately if I have concerns?
No. Abruptly stopping gabapentin can cause serious withdrawal effects, including seizures. If you have concerns, talk to the prescribing doctor about a gradual taper plan. Never discontinue gabapentin without medical supervision, especially in older adults or anyone who has been taking it for an extended period.
Why do doctors keep prescribing gabapentin off-label if the evidence is limited?
Several factors drive this pattern. The opioid crisis created urgent demand for non-opioid pain options. Gabapentin is inexpensive and widely available as a generic. Research has found that prescribers are often unaware of gabapentin’s limited approved indications, with prescribing decisions frequently based on informal colleague recommendations rather than formal evidence review. And the off-label prescribing habits established by Pfizer’s illegal marketing campaign in the 1990s and 2000s became self-sustaining within the medical community.
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For more, see NIH MedlinePlus — cognitive testing.
