Corporate Misconduct Accountability Project
CVS Pharmacy, Inc. · class action
CVS Sold Sleep Aid It Labeled Safe, Despite Habit-Forming Risks
A class action lawsuit alleges CVS marketed its Acetaminophen PM as non habit-forming despite knowing its active ingredient, diphenhydramine, can cause tolerance and dependency within weeks.
HIGH SEVERITY
TL;DR
CVS Pharmacy sold its Acetaminophen PM sleep aid with a prominent "non habit-forming" label on the front of the package. The lawsuit claims the product’s active ingredient, diphenhydramine, can cause users to develop tolerance in as little as 1-2 weeks, leading to dependency and potential abuse. Plaintiff Meghan McIntire alleges she developed a habit after relying on CVS’s safety claims. The complaint argues CVS knew about diphenhydramine’s risks but prioritized profits from a $65 billion global sleep-aid market over consumer safety.
This case exposes how profit-driven labeling can mislead millions seeking safe sleep solutions.
$65B
Annual global over-the-counter sleep-aid market
1-2 weeks
Time for tolerance to develop to diphenhydramine
22%
U.S. adults who reported using OTC sleep aids in 2023
1/3
American adults who regularly don’t get enough sleep
13,574
Antihistamine-positive overdose deaths in 2019-2020
71.1%
Of those deaths involved diphenhydramine
The Allegations: A Breakdown
Core Allegations
What CVS is accused of doing · 8 points
| 01 | CVS prominently labeled its Acetaminophen PM Extra Strength product as "non habit-forming" on the front packaging, despite the product containing diphenhydramine, a first-generation antihistamine known to cause tolerance and dependency. | high |
| 02 | The company knew or should have known that diphenhydramine can cause users to develop tolerance in as little as 1-2 weeks, requiring larger doses for the same effect and creating psychological and physical dependency. | high |
| 03 | CVS designed its label to grab consumer attention with the "non habit-forming" claim placed directly under the product name and usage description, intending consumers to read, understand, and rely on this claim when making purchases. | high |
| 04 | The company capitalized on the American sleep crisis, where more than one-third of adults regularly don’t get enough sleep, by falsely promising a safe solution to a harmful public health problem. | high |
| 05 | CVS’s misrepresentation caused consumers to pay a price premium for a product they believed was safer than alternatives, when in fact the product posed risks of habitual use that were not disclosed. | medium |
| 06 | The lawsuit cites substantial medical research documenting diphenhydramine addiction and misuse, including studies dating back to 1986, yet CVS continued marketing the product as non habit-forming. | high |
| 07 | Diphenhydramine elicits a cocaine-like pattern of dopamine transmission stimulation that can lead to misuse, according to the complaint, yet CVS made no disclosure of this addiction mechanism to consumers. | high |
| 08 | The company maintained the deceptive labeling uniformly and consistently for at least four years with no material changes to product packaging during the relevant period. | medium |
Regulatory Failures
How the system allowed this to happen · 5 points
| 01 | Diphenhydramine was first introduced in 1946 as Benadryl, when medications were not required to pass rigorous drug safety or efficacy testing, and the regulatory framework has not adequately caught up with modern research on addiction and dependency. | high |
| 02 | Over-the-counter products like CVS’s Acetaminophen PM face less stringent scrutiny than prescription drugs, allowing marketing claims like "non habit-forming" to go unchallenged if basic labeling guidelines are met. | high |
| 03 | The Canadian Society of Allergy and Clinical Immunology recommends that first-generation antihistamines like diphenhydramine should only be available behind the counter, and the Global Allergy and Asthma European Network supports prescription requirements, yet U.S. regulations remain lax. | medium |
| 04 | No asterisks or qualifying disclosures appear on the CVS product packaging to warn consumers about potential habit-forming properties, and even if such disclosures existed elsewhere, they would be buried in fine print unlikely to be seen at purchase. | high |
| 05 | The complaint suggests that regulatory agencies face budget constraints and complex bureaucratic processes that hamper swift enforcement, allowing questionable claims to persist until consumer lawsuits force action. | medium |
Profit Over People
How CVS prioritized revenue over consumer safety · 6 points
| 01 | CVS entered the lucrative over-the-counter sleep-aid market, which generates nearly $65 billion annually worldwide and continues rising, by repackaging diphenhydramine for sleep despite knowing its addiction potential. | high |
| 02 | The company strategically placed the "non habit-forming" claim on the front primary display panel where manufacturers reserve space for the most important and persuasive information designed to motivate purchases. | high |
| 03 | By falsely advertising the product as safe from dependency, CVS created a cycle where consumers believed they could use the product nightly, potentially developing tolerance that paradoxically increased their reliance and repeat purchases. | high |
| 04 | The lawsuit alleges CVS conducted internal market research and conjoint studies showing that the "non habit-forming" claim would lead consumers to believe the product was safe and motivate them to buy it. | high |
| 05 | CVS deliberately chose to market the product with the deceptive claim despite having exclusive control over the label and the ability to easily remove or qualify the "non habit-forming" statement. | high |
| 06 | The company’s constant, unqualified use of the "non habit-forming" claim across all packaging evidences its intent to convince consumers the product conforms to this false representation and drive sales. | medium |
Public Health and Safety
The medical risks CVS allegedly concealed · 8 points
| 01 | Diphenhydramine is associated with life-threatening toxicities, and among 92,033 overdose deaths during 2019-2020, 13,574 were antihistamine-positive, with 71.1% involving diphenhydramine specifically. | high |
| 02 | In 2017, diphenhydramine ranked among the ten drugs most frequently involved in overdose deaths that mentioned a specific drug on the death certificate, alongside fentanyl, heroin, cocaine, and methamphetamine. | high |
| 03 | Long-term, frequent use of first-generation antihistamines like diphenhydramine in adults 65 and older is associated with development of dementia and Alzheimer’s disease due to anticholinergic properties. | high |
| 04 | Hospitalized elderly people treated with diphenhydramine have an increased risk of delirium, and elderly adults are more sensitive to toxicity that can lead from sedation to coma. | high |
| 05 | The half-life of diphenhydramine can be as long as 18 hours, causing next-day hangover effects including poor attention, reduced memory, and poor sensory-motor performance that impairs driving worse than alcohol. | high |
| 06 | Cardiac toxicity, including prolonged QTc and arrhythmias, has been reported with diphenhydramine use, creating serious cardiovascular risks for consumers who believed the product was safe. | high |
| 07 | Plaintiff Meghan McIntire took the product as directed by CVS and developed a habit contrary to the "non habit-forming" claim, illustrating the real-world harm caused by the misrepresentation. | high |
| 08 | Continuous use of diphenhydramine may cause it to stop working as well, trapping users in a cycle where they need the drug to fall asleep but it becomes less effective over time. | medium |
Economic Fallout
The financial harm to consumers and communities · 5 points
| 01 | Consumers paid a price premium for CVS’s Acetaminophen PM based on the false "non habit-forming" claim, effectively overpaying for a product that was not as safe as represented. | medium |
| 02 | Plaintiff and class members would not have purchased the product, or would not have paid as much, if they had known the "non habit-forming" claim was false and the product could cause habitual use. | high |
| 03 | Sleep dependency can escalate into health complications requiring medical intervention, generating individual costs including medical bills and lost wages from missing work due to side effects like dizziness and sedation. | medium |
| 04 | Widespread usage of a habit-forming product increases overall healthcare burdens if addiction, tolerance, or overdoses become frequent, with costs borne by individuals, taxpayers, and the healthcare infrastructure. | medium |
| 05 | CVS potentially engaged in a cost-benefit analysis where the revenue from the falsely labeled product dwarfed the cost of potential litigation and fines, making the deception financially worthwhile. | high |
Corporate Accountability Failures
How CVS avoided consequences · 6 points
| 01 | CVS had exclusive control over the "non habit-forming" claim’s inclusion on labels, packaging, and advertisements, and could have easily stopped using the claim but deliberately chose to continue the deception. | high |
| 02 | The company knew or should have known at all relevant times that the "non habit-forming" claim misleads reasonable consumers, yet intentionally used it to cause purchases believing the claim was true. | high |
| 03 | Despite knowledge that consumers reasonably rely on the "non habit-forming" claim in deciding to buy the product, CVS chose to market it with this false statement to mislead consumers into buying or overpaying. | high |
| 04 | CVS named and marketed the product with the "non habit-forming" claim but opted to formulate it in a manner that does not conform to the representation, knowingly creating a disconnect between advertising and reality. | high |
| 05 | The company’s continued deception occurred despite its awareness that the falsely advertised product attribute is important to consumers and its understanding that consumers are motivated to buy products that conform to such claims. | medium |
| 06 | CVS labeled and packaged the product with the "non habit-forming" claim based in part on market research showing the claim would lead consumers to believe the product was safe, demonstrating calculated intent. | high |
Community Impact
Broader social consequences of the alleged misconduct · 5 points
| 01 | In a 2023 survey of 2,005 U.S. adults conducted by the American Academy of Sleep Medicine, 22 percent reported using over-the-counter sleep aids, representing millions of potentially affected consumers. | medium |
| 02 | More than one-third of American adults regularly don’t get enough sleep according to the CDC, creating a massive vulnerable population that CVS targeted with false safety promises. | high |
| 03 | Insufficient sleep is linked to depression, ADHD, obesity, type 2 diabetes, cardiovascular disease, cancer, and Alzheimer’s disease, making consumers desperate for solutions and particularly vulnerable to misleading marketing. | medium |
| 04 | The complaint characterizes CVS’s conduct as creating an epidemic of diphenhydramine dependency while promising a solution to America’s public health epidemic of sleeplessness. | high |
| 05 | Front-line CVS pharmacy employees are placed in ethical dilemmas when they see repeat customers purchasing large quantities of the product but have minimal training or authority to intervene, since the label says "non habit-forming." | medium |
The Bottom Line
What this case reveals about corporate conduct · 6 points
| 01 | The lawsuit alleges CVS capitalized on consumer preferences for safe, non-addictive products by falsely promising its Acetaminophen PM is "non habit-forming" when substantial medical evidence shows otherwise. | high |
| 02 | There is a significant body of research on diphenhydramine addiction and misuse spanning from 1986 to 2021, including at least 15 major studies cited in the complaint, yet CVS maintained its false labeling. | high |
| 03 | The primary active ingredient in CVS’s product is identical to the primary active ingredient in Benadryl that can lead to dependency, yet CVS marketed its version as distinctly safe from habit formation. | high |
| 04 | Plaintiff seeks injunctive relief because CVS continues to misrepresent the product with the "non habit-forming" claim, and injunctive relief is necessary to prevent ongoing deception and future harm that cannot be achieved through monetary damages alone. | high |
| 05 | The case exemplifies how corporations can exploit consumer trust, weak regulatory oversight, and information asymmetries to profit from false safety claims at the expense of public health. | high |
| 06 | A demand letter was sent to CVS on July 2, 2024, providing notice of violations and demanding the company correct its unlawful practices, but CVS continued selling the product with unchanged labeling. | medium |
Timeline of Events
1946
First antihistamine containing diphenhydramine (Benadryl) burst onto market when medications were not required to pass rigorous drug safety testing
1986
Medical literature begins documenting diphenhydramine abuse and withdrawal, with case studies of massive diphenhydramine abuse published in JAMA
2017
Diphenhydramine ranks among ten drugs most frequently involved in overdose deaths, alongside fentanyl and heroin
2019-2020
Among 92,033 overdose deaths, 13,574 (14.7%) were antihistamine-positive, with 9,645 (71.1%) involving diphenhydramine
2020-2024
CVS uniformly and consistently marketed Acetaminophen PM as "non habit-forming" with no material changes to product packaging
May 2024
Plaintiff Meghan McIntire purchased CVS Acetaminophen PM from San Diego CVS store, relying on "non habit-forming" label, and subsequently developed a habit
July 2, 2024
Demand letter sent to CVS headquarters and registered agent via certified mail, providing notice of CLRA violations and demanding corrective action
November 13, 2024
Class action complaint filed in U.S. District Court, Southern District of California, seeking relief for Meghan McIntire and all similarly situated consumers
Direct Quotes from the Legal Record
QUOTE 1
False claim on product packaging
allegations
“Non habit-forming”
💡 This is the exact claim CVS prominently displayed on the front of its product packaging that the lawsuit alleges is false and misleading.
QUOTE 2
Rapid tolerance development
health
“Tolerance can develop in as little as 1–2 weeks, requiring users to take larger and larger doses for the same sedating effect, and causing dependency in users who find they need diphenhydramine to fall asleep.”
💡 This establishes the medical fact that contradicts CVS’s "non habit-forming" claim, showing how quickly dependency can develop.
QUOTE 3
Cocaine-like addiction mechanism
health
“Diphenhydramine elicits a cocaine-like pattern of stimulation of dopamine transmission that can lead to misuse of medications containing diphenhydramine.”
💡 This reveals the serious addiction mechanism behind diphenhydramine that CVS failed to disclose to consumers.
QUOTE 4
Overdose death statistics
health
“Among drug overdose deaths in 2017 that mentioned at least one specific drug on the death certificate, the ten drugs most frequently involved included fentanyl, heroin, cocaine, methamphetamine, alprazolam, oxycodone, morphine, methadone, hydrocodone, and diphenhydramine.”
💡 This places diphenhydramine in the same category as highly addictive and deadly drugs like fentanyl and heroin.
QUOTE 5
Scale of diphenhydramine deaths
health
“Among 92,033 overdose deaths during 2019–2020, 13,574 (14.7%) were antihistamine-positive and 3,345 (3.6%) were antihistamine-involved. Nearly all antihistamine-positive and -involved deaths (13,475, 99.6%; 3,339, 99.8%, respectively) included first-generation H1 antihistamines, primarily diphenhydramine (9,645, 71.1%; 2,226, 66.5%, respectively).”
💡 This quantifies the deadly scale of diphenhydramine involvement in overdose deaths during a two-year period.
QUOTE 6
Link to dementia
health
“In adults 65 years and older, long-term, frequent use of first-generation antihistamines like diphenhydramine is associated with development of dementia and Alzheimer’s due to their anticholinergic properties.”
💡 This reveals a long-term health consequence particularly affecting elderly consumers who may have relied on CVS’s false safety claim.
QUOTE 7
International calls for restriction
regulatory
“Canadian Society of Allergy and Clinical Immunology recommends that first-generation antihistamines such as diphenhydramine should be considered for availability only on a behind-the-counter basis. The Global Allergy and Asthma European Network also supports implementing a prescription requirement for first-generation antihistamines like diphenhydramine.”
💡 Medical organizations internationally recognize diphenhydramine as dangerous enough to warrant restricted access, contradicting CVS’s safety claims.
QUOTE 8
Plaintiff’s experience
allegations
“When Plaintiff took the Product as directed by Defendant, she developed a habit, contrary to the ‘non habit-forming’ claim.”
💡 This shows real-world harm where following CVS’s directions and relying on their label led directly to the outcome they claimed wouldn’t happen.
QUOTE 9
CVS’s knowledge of consumer reliance
accountability
“Defendant knew, or should have known, that the ‘non habit-forming’ claim would lead reasonable consumers into believing that the Product was safe and would not result in habitual use based on internal conjoint and other marketing studies.”
💡 This establishes CVS conducted market research showing consumers would rely on this claim, demonstrating intentional deception.
QUOTE 10
Material misrepresentation
profit
“The ‘non habit-forming’ claim was and is material to reasonable consumers, including Plaintiff, in deciding to buy the Product – meaning that the Product’s ‘non habit-forming’ attributes are important to consumers and motivate them to purchase the Product.”
💡 This shows the false claim wasn’t just decorative but directly drove purchasing decisions and CVS’s profits.
QUOTE 11
Price premium harm
economic
“In making her purchase, Plaintiff paid a price premium due to Defendant’s false and misleading claim.”
💡 This establishes economic harm where consumers paid more money based on a lie about product safety.
QUOTE 12
Corporate control over labeling
accountability
“Defendant, as the manufacturer and marketer of the Product, had exclusive control over the ‘non habit-forming’ claim’s inclusion on the Product’s label, packaging, and advertisements – i.e., Defendant readily and easily could have stopped using the ‘non habit-forming’ claim to sell the Product.”
💡 This shows CVS had full control and could have easily removed the false claim but chose not to in order to keep profiting.
QUOTE 13
Deliberate marketing strategy
accountability
“Despite Defendant’s knowledge of the ‘non habit-forming’ claim’s falsity, and Defendant’s knowledge that consumers reasonably rely on the ‘non habit-forming’ claim in deciding to buy the Product, Defendant deliberately chose to market the Product with the ‘non habit-forming’ claim thereby misleading consumers into buying or overpaying for the Product.”
💡 This alleges CVS’s deception was not an accident but a deliberate business strategy despite knowing the truth.
QUOTE 14
Market size
profit
“Today, the over-the-counter sleep-aid market is a global juggernaut, reaping nearly $65 billion a year – a number which is only continuing to rise.”
💡 This establishes the enormous financial incentive CVS had to falsely market its product in this lucrative market.
QUOTE 15
Vulnerable consumer base
community
“According to the CDC, more than one third of American adults regularly don’t get enough of it.”
💡 This shows CVS targeted a massive vulnerable population desperate for sleep solutions, making the false claims particularly predatory.
Frequently Asked Questions
What exactly is CVS accused of doing wrong?
CVS is accused of labeling its Acetaminophen PM sleep aid as "non habit-forming" on the front of the package, despite knowing that its active ingredient, diphenhydramine, can cause tolerance and dependency in as little as 1-2 weeks of regular use. The lawsuit alleges this false labeling misled millions of consumers into believing the product was safe for regular use when it actually posed addiction risks.
Is diphenhydramine really addictive?
Yes, according to the lawsuit and substantial medical research cited. Diphenhydramine can cause both psychological and physical dependency. Users can quickly develop tolerance, requiring larger doses for the same effect. The complaint cites at least 15 medical studies from 1986 to 2021 documenting diphenhydramine addiction, abuse, and withdrawal. Between 2019-2020, diphenhydramine was involved in 9,645 overdose deaths, representing 71.1% of antihistamine-related deaths.
How does diphenhydramine cause addiction?
According to the lawsuit, diphenhydramine easily crosses the blood-brain barrier and elicits a cocaine-like pattern of dopamine transmission stimulation. This neurological effect can lead to misuse and dependency. Tolerance develops rapidly (1-2 weeks), causing users to need larger doses, and many find they become dependent on it to fall asleep, creating a habit.
What are the health risks of diphenhydramine?
The complaint cites numerous serious risks: life-threatening toxicities, 13,574 antihistamine-positive overdose deaths in 2019-2020 (with 71% involving diphenhydramine), cardiac toxicity including arrhythmias, increased risk of dementia and Alzheimer’s in adults 65 and older with long-term use, delirium in hospitalized elderly, next-day hangover effects lasting up to 18 hours, and driving impairment worse than alcohol.
How big is this problem?
The scope is massive. More than one-third of American adults regularly don’t get enough sleep. In 2023, 22% of U.S. adults reported using over-the-counter sleep aids. The global OTC sleep-aid market generates nearly $65 billion annually. CVS sells the product at thousands of stores nationwide, potentially affecting millions of consumers who relied on the "non habit-forming" label.
What is CVS getting out of this?
The lawsuit alleges CVS profited enormously from falsely marketing the product as safe. By labeling it "non habit-forming," CVS differentiated its product from competitors, charged a price premium, and encouraged repeat purchases. Consumers who developed tolerance might even increase their usage, further boosting sales. The complaint suggests CVS conducted market research showing the "non habit-forming" claim would motivate purchases.
Did CVS know about these risks?
The lawsuit alleges CVS knew or should have known about diphenhydramine’s habit-forming properties. Medical research documenting addiction and dependency has existed since 1986. As a major pharmacy chain that invests in product research and development, CVS had access to this knowledge. The complaint also states CVS conducted internal marketing studies showing consumers would rely on the "non habit-forming" claim, yet it deliberately continued using this label.
Why did regulators allow this?
The complaint points to regulatory failures. Diphenhydramine was approved in 1946 before rigorous drug safety testing was required. OTC products face less scrutiny than prescription drugs. The FDA’s oversight for older antihistamines hasn’t caught up with modern addiction research. Some international medical organizations recommend restricting diphenhydramine to behind-the-counter or prescription-only, but U.S. regulations remain lax.
Who can join this lawsuit?
The lawsuit seeks to represent nationwide and multi-state classes of people who purchased CVS’s Acetaminophen PM product within applicable statutes of limitations (generally 2-6 years depending on the state and legal claim). There’s a specific California subclass for California purchasers. If you bought this product and relied on the "non habit-forming" label, you may be part of the class.
What is the lawsuit asking for?
The lawsuit seeks class certification, monetary damages for consumers who overpaid or were harmed, restitution of profits CVS gained from the false labeling, injunctive relief requiring CVS to stop using the "non habit-forming" claim, and attorney’s fees. The complaint emphasizes that injunctive relief is crucial because CVS continues to sell the product with the same misleading label, causing ongoing harm.
What can I do if I bought this product?
If you purchased CVS Acetaminophen PM and relied on the "non habit-forming" label, you may be automatically included in the class if it’s certified. You can contact the attorneys listed in the lawsuit (Bursor & Fisher, P.A. or Smith Krivoshey, PC) for more information. You can also stop using the product if you’re concerned about dependency, consult with a doctor about safer sleep alternatives, and spread awareness about the alleged false labeling to protect others.
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