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What Took the FDA So Long to Warn About Z-Drug Dangers?

The FDA crows about its new drug approvals. It is less enthusiastic about black box warnings. Z-drug dangers now include sleep walking and sleep driving.

The Food and Drug Administration seems to take great pride in approving new drugs. Last year was “An All-Time Record, And A Watershed,” according to Forbes (Jan. 14, 2019).  The FDA shattered its old 1996 record by 20 percent. Nature Reviews Drug Discovery (Jan. 15, 2019) noted that…“analysts forecast combined peak sales of $45 billion for this year’s newly approved drugs, corresponding to average peak sales of only $720 million per drug.”  What the FDA does not brag about is its black box warnings. It can take many years for the FDA to alert physicians and patients to drug complications. That was certainly true when it came to Z-drug dangers. These sleeping pills remain very popular.

The FDA Approval Process:

The regulators at the FDA maintain that they never approve a drug unless it is proven to be safe and effective. In commenting upon new drug approvals for 2018 the FDA states proudly:

“Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process.”

The pharmaceutical industry contributes an extraordinary amount of money to the Food and Drug administration to review its drugs. According to the nonprofit investigative journalist group, ProPublica (June 26, 2018)

“In 2017, pharma paid 75 percent — or $905 million — of the agency’s scientific review budgets for branded and generic drugs, compared to 27 percent in 1993.”

“FDA Repays Industry by Rushing Risky Drugs to Market

“As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits.”

FDA Warnings: Slower Than Molasses

When it comes to alerting health professionals and the public to drug problems, the FDA moves far more slowly. That seems to be the case with its latest warning about popular Z-drug sleeping pills. The agency will require manufacturers of eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien) to put a prominent boxed warning on their medications.

Z-Drug Dangers?

People taking these Z-drugs need to know that they run the risk of sleep walking, sleep driving or other “complex sleep behaviors.” People have died from car crashes, falls, drownings and other mishaps carried out when they were not fully conscious.

Ambien has been on the market for more than 25 years. More than a decade ago, we began hearing that readers had been sleep-driving while on Ambien. Here are a few of those early stories:

“I had a terrible experience with Ambien about a month ago. I took the drug at bedtime, then had hallucinations and got in my car to escape. I don’t remember a thing, but the police stopped me and my boyfriend had to bring me home.

“A short time ago, I tried taking Ambien again. This time too I had terrible hallucinations and got in my car and drove. I don’t remember a thing about it, but I was arrested and spent 24 hours in jail. Because of the Ambien, I slept almost the entire time. I had to have an attorney and have lost my job as an RN. Have you heard of other people who have had such serious problems with Ambien?”

Another reader wrote to us:

“Ambien made me sleep-walk, -eat, and-drive! I would wake up with food in my bed not remembering anything that happened.

“My mother said I would walk into the living room and start talking to her. I had no recollection of this.

“A year ago, I woke in the hospital with a broken femur, ankle, patella, fractured skull and broken finger. I had been sleep-driving!

“I never wear pajamas when I drive, EVER! I had my pjs on when they found me, so I believe I went sleep-walking to the car, started driving and totaled my car into a tree!”

In 2008, we got this tragic report:

“I believe my friend was sleep-driving when he was killed in a car accident. A dump truck slammed into his car at an intersection he’d known all his life. It was only two blocks from his house.

“I called his wife to get the story and she said he reportedly ran a blatant red light on his way to work. That is certainly not like him, especially because he was applying for a police job. If you’re doing that, you don’t go through red lights, for sure.

“When I’d talked with him not five days earlier, he had told me he was on Ambien. He said if he didn’t get enough sleep, he would do strange things. I feel the Ambien caused him, a husband and father of two, to be killed needlessly because he was probably sleep-driving under its influence.”

Decades of Z-Drug Dangers:

The FDA says it has received 66 such reports on Ambien and related sleeping pills since 1992. People fell, burned themselves, shot themselves, took other medicine and overdosed, and wandered outside in extremely cold weather. Twenty of these incidents were fatal.

Doubters of Z-drug Dangers:

Joyce questions how people could remember Z-drug disasters:

“I don’t mean to be facetious. If people have a complex sleep behavior and don’t remember, then how do they know they had one?”

The answer comes from a woman who didn’t remember but had to piece things together. She wrote to us several years ago:

“I am facing a DUI charge from an accident that I was never conscious for. My blood alcohol levels was 0. I wasn’t drinking. I have NO memory of this incident whatsoever.

“I have been trying to put this puzzle together for months. None of this is real to me.What I believe happened was this:

“After a long day of moving out of my apartment I went back to my friend’s house where I was staying in-between, I Took zolpidem and jumped in the shower ready to go straight to bed. I ate something and fell asleep watching TV.

“I apparently left in the car, and in the process, drove into an electrical pole and knocked it over.
I woke up in the hospital emergency room the next day with NO recollection of anything. The only way I’ve put this puzzle together was when information slowly started trickling in over the days to follow my accident.

“I returned to my friend’s place after being released from the hospital. She mentioned that I left a note on her bedroom door that said I needed to go spend the night at my new place to be with my babies (my cats!) It was when she said this that I remembered writing the note. A few days later I came across another note on my closet floor that said the same thing, and written to the same friends. I would never have remembered it had I not seen it. It said the same thing. That I wrote two notes tells me I forgot I ever wrote the first because I was already in a ‘hypnotic state.”

“The night of the accident I was eating in the TV room with both of my friends. They say they knew I had taken a shower and was going to bed because I had PJ’s on. They say I seemed fine. I said goodnight and went up to bed. About a half hour later they heard the front door and didn’t know I left until the hospital called them.

“My life is not mine anymore, I suddenly face a DUI charge. My Public Defender could care less about me.”

Share your own story about Z-drug dangers in the comment section below.

You will find more information on the hazards of Z-drugs as well as suggestions for overcoming insomnia in our eGuide to Getting a Good Night’s Sleep. It is available in our Health Guide section.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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