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FDA Lowers Dose of Popular Sleeping Pill

Zolpidem is one of the most popular sleeping pills in the pharmacy. According to IMS Health, an organization that tracks such things, nearly 40 million zolpidem prescriptions were dispensed last year. It is sold under a variety of names including Ambien, Ambien CR, Edluar, Intermezzo and Zolpimist.
Ambien was first approved by the FDA as a sleeping pill in 1992. It was initially perceived as safer and perhaps more effective than prior “hypnotics.” But after more than two decades, the FDA has issued a brand new warning and an unusual dosage adjustment.
On Thursday, January 10th, the Food and Drug Administration announced that women should avoid the 10 mg dose and instead take no more than 5 mg of the standard release zolpidem tablets. The reason is that some women may end up with higher blood levels of zolpidem that could persist longer in the body and possibly lead to morning hangover and slower reaction times. Although many people might not realize it, they could be impaired during the day and more susceptible to accidents. The FDA is also suggesting that women avoid the zolpidem slow release 12.5 mg dose (Ambien CR) and use the 6.25 mg dose instead. The FDA is encouraging doctors to prescribe lower doses of zolpidem for men as well.
Do you not find it fascinating that it has taken the FDA more than two decades to discover this problem? It just reinforces the reality that it often takes years (or decades) to discover some adverse drug reactions.
We began to suspect that there were some unusual problems with Ambien a long time ago, thanks to readers of our syndicated newspaper column and visitors to this website. Here are just some of the scary stories we have received over the years:
This Q&A came to us six years ago:

Q. 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?

A. There are reports of hallucinations, sleepwalking and sleep-driving associated with the sleeping pill Ambien. In one case a woman (another nurse) walked out of the house on a cold Colorado night wearing just a thin nightie. She got into the car and drove until she had an accident. When she was being arrested, she became violent with the officers, but later could remember nothing about the event. Sleeping pill-induced amnesia has been reported for years.

Q. What do you know about the sleeping pill Ambien? A friend of mine has been taking it occasionally for years. The other night she took one and when she awoke the next morning, she saw signs that she had done things during the night but had no recollection of doing them. She was so alarmed that she crushed her pills and threw them out.

A. We have heard from many others who report unusual behavior after taking Ambien. One woman wrote that her husband began sleepwalking after taking this sleep aid:

“He woke me saying there was something terribly wrong with the computer. I got up and found coffee spilled all over the desk and the cords to the keyboard and mouse cut with scissors. He did not remember doing this.
“On another occasion, he thought that someone had kidnapped his brother and put him in the trunk of a neighbor’s car. He’d gone out in his pajamas and jumped up and down on the car, screaming for someone to let his brother out. He had smeared chocolate pudding on his face like a commando. The neighbors called the police and we had to pay the damages, nearly $1,500.”

“I got ready for bed around 10:00 pm last night, took Ambien and fell asleep. The next morning my dog woke me up to let him out. As I passed through the kitchen I realized I had been sleepwalking/driving that night. I found a doggie bag full of food from a restaurant in the trash, my car was scratched up, my front door wide open.
I don’t understand how I could drive to a restaurant, order food, eat the food, ask for a doggie bag and pay the check (that’s if I even paid for it). I called my doctor to change medications and let her know what happened. I must have been very hungry.”

“Doctors have given me two drugs. One is Sonata, which only helps for about three hours. The other is Ambien, which seems to affect my balance the next day and make me light-headed.”

“Here’s an interesting event that happened to me two nights ago: In my “mind” I took one 10 mg Ambien and went to bed. The next morning I woke up around 9:00, got a call from a coworker and finished packing for a business trip. I met him downstairs and told him I had to go to the bank to transfer some money to my wife’s account.
“When I called her to ask for the acct #, she asked me how I was feeling. I replied, “I’m fine. Why?” she tells me “Hon, you were in the hospital for almost 8 hrs last night after you wrecked your car!”
“Apparently, I got back up about 1 hour after going to sleep, got into an argument with someone at the front desk of the hotel I’m staying in over god-only-knows what, then I drove 2 miles to a gas station (why, I still don’t know) and when I left the gas station I drove over an embankment where my car got stuck.
“The police showed up and I have no idea what happened but they took me to the ER, gave me a CT scan, almost put me on the mental ward for telling the doctors that I was going to have them killed because my wife is a ninja (no kidding!). I told them it was 1997 and we were in Georgia (this happened in NC…), and I tried to “escape” dozens of times over the next 8hrs.
“I have no memory AT ALL of any of this! I’m sore as hell, probably from fighting doctors, cops, and security guards and I’m scared to death I’m going to have legal charges leveled against me. I don’t drink or use drugs and ALL I took WHILE LAYING DOWN was ONE 10 mg Ambien. All the hospital found in my blood was ONE AMBIEN. I didn’t drink before or after taking it, or mix it with any other prescriptions.
“The warning label on this stuff should read “Close supervision required” because I almost killed myself and nearly wound up in a mental hospital —> all for doing something while I was dead asleep.”

“My doctor prescribed Ambien for sleeplessness after my husband died. I found a whole pill was too much, as I could not wake up in the morning. I tried cutting the pill in half and slept well. After reading all these horror stories I decided I did not want to take Ambien any more and switched to one Tylenol PM. I sleep well and wake up more refreshed.”–Joyce

These are just some of the stories we have received over the last few years. One other warning about zolpidem that is underappreciated is heartburn. It may seem like a minor problem compared to the stories you have read above, but many people have reported severe reflux symptoms associated with zolpidem.
Here is just one example:

“I was prescribed Ambien for insomnia, then began experiencing reflux and heartburn nightly. After a few weeks, it occurred to me that the heartburn began about the same time I started the Ambien.
“As I was only instructed to take the Ambien ‘as needed’, I stopped immediately and went online to research this. I found many, many instances of people who’d experienced the same thing. Of course, my doctor was surprised, as she had never heard of this before.”

Other people have reported problems with certain generic formulations of Ambien. That is to say, some generics just don’t work as well for them as the brand name.

“Without my approval, I was given a generic substitute for Ambien. The generic drug simply did not work for me. I was awake till 7 AM. The pharmacist insisted that the generic version was the same drug, only with different fillers.”

“I was surprised to read the information about Ambien vs zolpidem. I have complained to my Dr. and pharmacist ever since being switched, and they act like it is in my head. Now I know it is not after reading all of the posts. There is a difference.”–Brenda

If all this is getting you down, why not consider some other ways to get your zzzs. Our Guide to Getting a Good Night’s Sleep offers some non-drug approaches, along with pros and cons of many sleeping pills, including zolpidem. If there is a moral to this story, it is that it can take the FDA a VERY long time to discover serious adverse drug reactions. Do not assume that the side effect information you get along with your prescription is the last word on the safety of your medicine.
If you have had experience with zolpidem, please share your story below. And if you have successfully treated your insomnia without drugs, please let us know how you did it.

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About the Author
Terry Graedon, PhD, is a medical anthropologist and co-host of The People’s Pharmacy radio show, co-author of The People’s Pharmacy syndicated newspaper columns and numerous books, and co-founder of The People’s Pharmacy website. Terry taught in the Duke University School of Nursing and was an adjunct assistant professor in the Department of Anthropology. She is a Fellow of the Society of Applied Anthropology. Terry is one of the country's leading authorities on the science behind folk remedies..
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