Medical professionals are mounting a significant challenge against one of the most common medicines found in households across America, asserting that its potential dangers now far exceed its therapeutic benefits. Physicians specialising in internal medicine are urging the Food and Drug Administration to withdraw over-the-counter access to diphenhydramine, the active component in the widely recognised allergy and sleep aid Benadryl, due to mounting evidence of serious health risks.
The Ubiquitous Allergy Remedy Under Scrutiny
Diphenhydramine remains a cornerstone of self-treatment for millions of American adults and children seeking relief from seasonal allergies or assistance with sleep. Its position on pharmacy shelves as a trusted remedy for symptoms like runny noses, sneezing, itchiness, and watery eyes has been largely unchallenged for decades. However, a growing body of clinical evidence presented by doctors from prestigious institutions including Johns Hopkins University School of Medicine and the University of California, San Diego, suggests this confidence may be dangerously misplaced.
Substantial Neurological and Cognitive Concerns
The primary argument centres on the drug's capacity to cause what researchers term 'substantial' brain damage with prolonged use. As a first-generation antihistamine, diphenhydramine readily crosses the blood-brain barrier, inducing pronounced drowsiness while simultaneously impairing alertness, coordination, and cognitive function. This sedation carries significant real-world consequences, from diminished workplace productivity and compromised academic performance to a markedly increased risk of road traffic accidents. Alarmingly, some controlled studies have demonstrated that its impact on driving capability can exceed the impairment caused by exceeding legal alcohol limits.
Beyond immediate drowsiness, the medication triggers a spectrum of adverse effects ranging from uncomfortable to potentially dangerous. These include dry mouth, constipation, blurred vision, confusion, and urinary retention—symptoms that pose particular hazards for elderly patients. Furthermore, the drug's accessibility has led to concerning patterns of misuse, especially among younger demographics.
Long-Term Health Implications and Dementia Link
Perhaps most worryingly, extended or frequent usage of diphenhydramine has been associated with serious cardiac rhythm disturbances and a substantially elevated risk of developing dementia. A landmark 2015 study published in JAMA Internal Medicine, which tracked over 3,400 older adults for seven years, revealed startling statistics. Frequent users faced a 54 percent higher likelihood of dementia diagnosis and a 63 percent increased risk of Alzheimer's disease compared to non-users.
The recognition of these risks is not new in certain regulated environments. European medication labels explicitly warn against operating vehicles after consumption, while United States aviation authorities prohibit pilots from using the drug during flight duties. Despite these precautions, diphenhydramine maintains its over-the-counter status and remarkable popularity across America.
The Rise of Safer Alternatives
Medical experts highlight the availability of superior second-generation antihistamines developed in the late twentieth century, such as fexofenadine (marketed as Allegra) and loratadine (found in Claritin). These newer formulations provide equivalent allergy relief without the problematic sedative effects, thanks to their inability to penetrate the brain's protective barrier. They offer longer-lasting symptom control with a significantly reduced side-effect profile, yet remain similarly priced and readily available without prescription.
Despite these advantages, diphenhydramine persists as one of the nation's most purchased over-the-counter antihistamines. This enduring popularity stems from multiple factors: its inclusion in hundreds of combination products targeting allergies, colds, and insomnia; decades of positive advertising; entrenched prescribing habits among healthcare providers; and deeply rooted self-treatment behaviours among the public.
Social Media Challenges and Tragic Overdoses
The dangers of unsupervised access have been tragically illustrated through social media phenomena like the 'Benadryl Challenge,' which encouraged young people to consume dangerously high doses to induce hallucinations. This trend claimed the life of Jacob Howard Stevens from Greenfield, Ohio, who suffered fatal seizures after ingesting twelve to fourteen pills—far exceeding the typical one to two pill dosage. In May 2020, Cook Children’s Hospital in Fort Worth, Texas, issued urgent public warnings after treating three teenagers for Benadryl overdoses linked to TikTok videos.
A comprehensive ten-year review of poison centre data, published last year in the journal Pediatrics, revealed an alarming 87 percent increase in intentional diphenhydramine overdoses among children and adolescents, with suicidal intent more than doubling. Ninety percent of these cases required hospital or clinic treatment, with one in five patients admitted to critical care units.
Economic Burden and Healthcare Costs
Advocates for regulatory change emphasise the substantial economic burden imposed by diphenhydramine-related adverse events. The drug is responsible for thousands of hospitalisations annually, generating significant costs through emergency department visits, inpatient admissions, and physician consultations. Indirect costs from reduced workplace and educational productivity further compound the financial impact on the healthcare system and broader economy.
The physicians leading this initiative conclude that removing oral diphenhydramine from over-the-counter availability would deliver substantial public health benefits while generating healthcare savings. They acknowledge that requiring a prescription would limit consumer choice for those who prefer the older medication but argue this minor inconvenience is overwhelmingly outweighed by the protection of patient safety. As the evidence of harm accumulates, maintaining the current regulatory status quo appears increasingly untenable from both medical and economic perspectives.
