Gabapentin: Not a Panacea

How a Promising and “Safe” Alternative Became a Risky Go-To

When gabapentin (Neurontin) was first approved by the FDA in 1993, its intended use was narrow and well-defined for the treatment of epileptic seizures and postherpetic neuralgia, a painful condition following shingles. Its ability to modulate calcium channels in the central nervous system made it a valuable anticonvulsant with undeniable clinical utility. Another shining example of the positive societal impact of well funded pharmacological R&D pipelines supported by a well-defined and predictable regulatory framework.

However, over time,  many clinicians began to explore its off-label potential for a range of patient conditions, ranging from neuropathic and musculoskeletal pain to anxiety, migraine prevention, and even mood disorders were being treated with gabapentin. By the mid-2000s, gabapentin had become a go-to medication for chronic pain, particularly as healthcare providers sought non-opioid alternatives in response to the crippling opioid crisis.

Gabapentin was not federally classified as a controlled substance and was not included in the DEA’s morphine milligram equivalent (MME) tracking, so prescribers viewed it as a safer option that could be prescribed freely without scrutiny from regulators. However, the characterization of gabapentin as a low-risk therapeutic option has been disproven.


A Surge in Prescribing

According to a 2025 CDC analysis, gabapentin prescribing more than doubled between 2010 and 2024, rising from 79.5 to 177.6 prescriptions per 1,000 people. It is now the fifth most dispensed medication in the United States, with over 15 million Americans receiving it in 2024. Prescriptions have increased most notably among older adults and women, with primary care providers accounting for the largest share of orders.

Although the drug’s rate of increase has slowed since 2016, the scale of its use raises critical questions about both efficacy and safety. Gabapentin is FDA-approved only for seizures and postherpetic neuralgia, yet it is now widely used for conditions where evidence of benefit remains limited.


Hidden Risks: From Respiratory Issues to Cognitive Decline

Common side effects first surfaced by the FDA in 2019 related to respiratory depression and included incidences of dizziness, drowsiness, impaired coordination, blurry vision, and confusion. However, emerging research from 2026 has uncovered more severe long-term risks. A recent study has linked frequent gabapentin use for chronic pain to a significantly increased risk of dementia and mild cognitive impairment (MCI). Notably, this risk appears most pronounced in middle-aged adults (ages 35–64), a demographic previously thought to be less vulnerable to cognitive side effects. This challenges the assumption that the drug is benign for long-term pain management in younger populations.


Misuse and Regulatory Changes

Misuse and diversion have also become growing concerns. Individuals with a history of substance use disorder sometimes take gabapentin to enhance the effects of opioids or to manage withdrawal symptoms. As a result, several states including Kentucky, Tennessee, and Michigan have reclassified gabapentin as a Schedule V controlled substance and require its monitoring through state Prescription Drug Monitoring Programs (PDMPs).

The irony is that gabapentin’s surge in popularity stemmed from its reputation as a “safe” pain alternative. The reports of misuse, side effects, and diminished benefit in chronic pain settings increased with the increase in scripts. It is not the non-opioid catch-all many hoped it would be and certainly not without significant risks when prescribed without clear indication or careful oversight.

While it remains a valuable medication for specific conditions, its off-label expansion and increasing misuse underscore the importance of evidence-based prescribing, patient education, drug compliance monitoring, and ongoing vigilance by clinicians and regulators alike.


CITATIONS:

Gabapentin Use Linked to Increased Dementia Risk in Patients With Chronic Back Pain (Pharmacy Times)

Increase in gabapentin dispensing highlights need for awareness of adverse effects (ACP Journals / Annals of Internal Medicine)

FDA Drug Safety Communication: FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin and pregabalin

Gabapentin facts and statistics 2026 (SingleCare)

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