Chapter 8
Why Haven’t You Heard This Opinion of Sleeping Pills From Every Expert?

“The treatment of insomnia by drugs is always to be avoided as much as possible.” - H.C. Woods, 1893

The idea that sleeping pills have a dark side is nothing new, as shown by the quote from an 1893 textbook by Dr. Woods. See Chapter 5 for expert opinions and guidelines. Indeed, generations of physicians have shared my negative opinion, based on their own clinical experiences. Probably, the majority today agree. They are a silent majority, with little to be gained by making their opinions public.

The sleeping pills industry has had billions of dollars of yearly sales, and it has thought of many subtle ways of keeping its products popular. To be frank, the manufacturers of sleeping pills have often given the leaders of sleep research large monetary grants to test their products. As a young scientist, I did some of that testing myself before I saw that sleeping pills were doing more harm than good. These research colleagues are very nice people who are not the sort to bite the hand that feeds them. Some of the most prominent leaders of sleep research have been supported mainly by drug company grants and consulting fees. I still receive drug company offers, though now I refuse them. The drug companies have used many subtle free offers and not-so-subtle methods of influencing the wider group of sleep clinicians to mute their critical attitude towards sleeping pills.

For example, several years ago, manufacturers offered free chocolate cream pie at a national sleep meeting for attendees to watch a bizarre comic session in which leaders of the sleep community mocked the FDA for its efforts to regulate sleeping pills. I suppose a good deal of money was spent for those free chocolate cream pies and the advertising of that ridicule of the FDA.

For many years, the National Sleep Foundation launched a yearly publicity campaign about the dangers of insomnia, encouraging everybody to sleep eight hours. Scientific evidence to support eight hours sleep is almost nonexistent. Could this campaign have been influenced by the fact that much of the National Sleep Foundation’s money came from sleeping pill manufacturers? The public relations firm for Ambien bragged that National Sleep Foundation publicity was effective in increasing sleeping pill sales.[65]  I believe more recently, the National Sleep Foundation has broadened its support to mattress and pillow manufacturers and I do not know what other groups with something to sell. The Foundation no longer details their sources on their web site.

The American Academy of Sleep Medicine received strong financial support from sleeping pill manufacturers in the past, but they do not seem to openly list that financing any more.

Unfortunately, almost nobody advertises for behavioral treatments of insomnia or for hypnotic abstinence. The advertising for bright light treatment is minuscule compared to pharmaceutical advertising.

8.A. Why haven’t you heard from the FDA?

When we reported that people who took sleeping pills died 4.6 times faster and suffered more cancer,[66]  I made quite certain that the FDA had reviewed the new studies. Also, by that time, the FDA’s own internal documents showed that the FDA knew that for the majority of patients, Ambien doses were likely to be ineffective, unsafe, or both.[67]  Forgive my naivety. Ignoring, at that time, 21 studies showing that people who take sleeping pills die sooner or suffer more cancer, some suggesting that sleeping pills were as dangerous as cigarettes, the FDA still claimed (in August, 2012) that sleeping pills were “safe and effective.” It may not surprise you that currently, the FDA public relations person who made that “safe and effective” claim for hypnotics is now employed by a sleeping pill company, no doubt well-paid. The FDA decided to require no black box warnings about mortality and cancer risks for zolpidem and similar drugs, nor did the FDA require further studies to confirm whether the mortality and cancer risks are substantial.

When the FDA took no practical steps to warn the public about sleeping pill mortality and cancer risks, and gave only minimalizing mention of proven depression and infection risks, I formally petitioned the FDA in October 2015 to require more warnings and more research to clarify how much sickness and early death were caused by sleeping pills. Although the law required (as the FDA admitted) that it respond to my petition within 6 months, the FDA gave no substantial reply, responding mainly that the problem was too complex for them. Also, evidently fearing that I would be proven correct, neither the FDA nor the manufacturers dared to initiate the large clinical trials needed to more accurately determine the magnitude of the unnecessary mortality and disability that sleeping pills cause.

Perhaps we should not have expected the FDA to protect the public. A 2009 report of the Congressional Government Accountability Office questioned the FDA’s ability to protect Americans from unsafe medical products.[68]  A 2012 National Institute of Medicine report found that the FDA’s current oversight was not adequately assuring the safety of marketed drugs.[69]  The FDA Amendments Act of 2007 gave the FDA authority to require additional safety studies on marketed drugs when needed, but these were not ordered. The Act provided authority to require risk evaluation and mitigation strategies, but the FDA disclosed no such evaluation and mitigation strategy to deal with cancer and mortality risks of sleeping pills. To give another example, in a September, 2012 lawsuit and press release, Public Citizen alleged that the FDA was acting unlawfully in failing to protect the public from an Alzheimer’s Disease drug, because it had “chosen to support the profit interests of a large pharmaceutical company.”[70]

Given their health impact, the National Institutes of Health (NIH) also have responsibility to clarify the risks of sleeping pills (see Chapter 9). NIH has made no effort. With planned budget cuts, one cannot anticipate that NIH sleeping pill research will expand. The medical insurance companies could determine from their own medical databases whether hypnotic users are developing more cancers or dying sooner. Medical insurance companies and Medicare-Medicaid programs should examine why they are paying for sleeping pills which are increasing medical costs.[71]  Fortunately, the Veterans Adminisration health system is slowly taking increasing efforts to reduce use of sleeping pills.

8.B. What if your family was injured?

If somebody in your family died or developed cancer after taking sleeping pills, you may have an entitlement to reimbursement for injury. Equally important, injured families could spread warnings. When the medical community was no match for the cigarette companies, lawyers and law suits helped disclose cigarette risks. Many state and local governments are now suing opioid manufacturers and providers for pushing opioid addicting drugs that are killing so many thousands. A substantial percentage of patients dying from opioids were at the same time receiving addicting sleeping pills and similar benzodiazepine agonists, for which similar litigation is needed.

We now need litigation for failures to disclose sleeping pill risks. If your family member died while regularly taking sleeping pills, and that risk was not disclosed, consult your attorney. If your family member developed a cancer while taking sleeping pills, especially esophageal or lung cancers or lymphoma, and that risk was not disclosed, consult your attorney. In Wyeth v. Levine[72], the U.S. Supreme Court ruled that drug manufacturers are liable if failing to warn patients, even when the FDA has not required a warning in the labeling. If the drug companies, the many doctors taking gifts and money from drug companies, the FDA, and the insurance systems will not alert the public to the risks of sleeping pills, injured families might have to give the warnings through legal assistance. You may contribute to better warnings if injured patient families and whistle blowers file enough lawsuits, recovering damages like the $4.85 billion which one company paid to settle Vioxx claims.[73] You might help save hundreds of thousands of lives.

Endnotes for Chapter 8

65. Kripke, DF.  Chronic hypnotic use: Deadly risks, doubtful benefit.  Sleep Medicine Reviews.2000;4:5-20. [return]

66. Kripke DF, Langer RD, Kline LE. Hypnotics’ association with mortality or cancer: a matched cohort study. BMJ Open. 2012;2:e000850Link to a website outside this eBook. [return]

67. Farkas, R. Center for Drug Evaluation and Research Approval Package for: Application Number: 019908Orig1s032s034, 021774Orig1s013s015. 2013. Silver Spring, MD, FDA. [return]

68. United States. Comptroller General. General Accounting Office. FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs, GAO-09-581, Jun 19, 2009, available as a free PDF document at the GAO website, www.gao.gov/new.items/d09581.pdfLink to a website outside this eBook. [return]

69. IOM (Institute of Medicine). 2012. Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Washington, DC: The National Academies Press. Available fdor download as a free PDF from the National Academies Press at dx.doi.org/10.17226/13219Link to a website outside this eBook. [return]

70. Bradbery, Angela. Public Citizen Sues FDA for Failing to Act on Request to Ban Dangerous Dose of Alzheimer’s Drug Aricept. Public Citizen, Inc. September 5, 2012. Text of press release available online at www.citizen.orgLink to a website outside this eBook. In November 2012, the FDA decided it had not made a mistake in approving the drug and rejected Public Citizen's petition. Wolfe, Sydney. FDA Rejects Petition to Ban Aricept 23: Did Drug Companies, FDA Collude in Approving Dangerous Alzheimer’s Drug? Public Citizen, Inc. November 6, 2012. Statement of Dr. Wolfe available online at www.citizen.orgLink to a website outside this eBook. [return]

71. Kripke, DF.  What do hypnotics cost hospitals and healthcare?  F1000Res. 6, 542.Link to a website outside this eBook  2017. IOM (Institute of Medicine). 2012. [return]

72. Wyeth v. Levine, 555 U.S. 555 (2009). The full text of the majority opinion by Justice John Paul Stevens, as well as the concurrences and dissent, are available at Cornell University Law School's online Legal Information Institute, at www.law.cornell.edu/supct/html/06-1249.ZS.htmlLink to a website outside this eBook, while a summary of its holdings may be found at Wikipedia, en.wikipedia.org/wiki/Wyeth_v._LevineLink to a website outside this eBook. [[return]

73. See Wikipedia's summary of the Vioxx case history, as part of its article on Merck and Co., Inc., available online at en.wikipedia.org/wiki/Merck_%26_Co.#VioxxLink to a website outside this eBook. [return]