Doctor Demands FDA Regulate Sleeping Pills

SAN DIEGO (CN) — Already under congressional scrutiny for failing to regulate opioid drugs, the Food and Drug Administration faces a lawsuit from a University of California professor who claims it's doing a poor job with sleeping pills too.

Hypnotics, or sleeping pills, are among the most-prescribed drugs in the county, Dr. Daniel Kripke says in his federal lawsuit against the FDA, the U.S. Department of Health and Human Services and the U.S. Center for Drug Evaluation and Research.

Kripke, a 1961 graduate of Harvard who got his M.D. from Columbia in 1965, is a professor emeritus at the University of California-San Diego.

"Hypnotic drugs are the immediate cause of death of more than 10,000 Americans per year, and possibly as many as 34,000 inadvertent, accidental or deliberate deaths per years," Kripke says in the May 19 complaint. He says the drugs are probably "as least a causal co-factor" in as many as 300,000 deaths a year.

Kripke has published research on hypnotic drugs for more than 40 years. He says that 33 or 34 scientific studies of the risks associated with hypnotics found they can kill by slowing the breathing rate. Other studies indicate that hypnotics are associated with depression and suicide, increased risk of cancer, and serious and potentially lethal infections such as pneumonia, liver infections, and asthma exacerbation.

Kripke says they also contribute to dangerous falls and hip fractures in elderly patients and car collisions from impaired driving.

He believes hypnotics-related deaths are underreported, as deaths that occur quietly at night are rarely examined via autopsy, especially if other chronic conditions are at play. Medical examiners often list the cause of death as cardiac arrest or stroke without realizing that respiratory suppression from hypnotic use was responsible, according to the complaint.

Kripke claims that the demonstrated harms of hypnotics outweigh the benefits, but the FDA does not regulate hypnotics, conduct epidemiologic health testing, or respond to citizen petitions about them.

Since the FDA fails to perform its statutory duty and is endangering public health, Kripke says, he filed a petition on Oct. 26, 2015, to compel it to act. Drugs at issue include those sold as Ambien, Doral, Sonata, Lunesta, and Restoril, and barbiturates including pentobarbital, amobarbital, and secobarbital.

Kripke says he asked the FDA to require manufacturers to perform placebo-controlled trials of hypnotics; issue "dear doctor" letters on the risks of long-term use; restrict off-label uses; and include information about mortality risks on the labels.

The FDA has 180 days to respond to such a petition, but sent him a form letter saying it could not reach a decision because the issue requires analysis by agency officials. Kripke calls that response statutorily inadequate and a violation of the Administrative Procedures Act and the federal Food, Drug, and Cosmetic Act.

FDA spokeswoman Sarah Peddicord said the agency does not comment on pending litigation.

Kripke seeks declaratory judgment that the FDA's failure to take action is unlawful, and a court order compelling it to take the actions requested in his petition and to respond by a court-appointed deadline.

He is represented by Gregory Weston.

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