Safety Concerns Mount for Sleeping Pill Zolpidem (Ambien)

A brand new analysis by the ISMP (Institute for Safe Medication Practices) Quarter Watch reveals a surprisingly high incidence of problems associated with the sleeping pill zolpidem. It is found in Ambien, Ambien CR, Intermezzo, Edluar and Zolpimist.

ISMP researchers monitor FDA’s Adverse Event Reporting System (FAERS) and look for signals of drug problems. Over a 12-month period they identified “1,030 serious adverse event cases in which zolpidem was the primary or secondary suspect drug.” They note that:

“In 2014, the CDC reported a survey of emergency department (ED) visits for adverse drug events resulting from use of all psychiatric medications taken by an estimated 26.8 million adults. The investigators said they were surprised to discover that zolpidem ranked first in adverse drug event cases, accounting for 11.5% of all ED visits among all adults, and 21% in patients 65 years or older. The study estimated that zolpidem accounted for 10,212 annual ED visits, substantially more than the 2nd ranked drug, the antipsychotic quetiapine (SEROQUEL), with 6,900 ED visits.”

According to ISMP’s Quarter Watch, 5 million Americans take zolpidem each year. That’s because so many of us have trouble falling asleep or staying asleep. A pill seems like a simple solution to the insomnia problem. The trouble is that there are serious concerns about the benefit/risk ratio.

How Effective Is Zolpidem?

The most recent Quarter Watch raises some serious questions about the effectiveness of zolpidem when it comes to getting a good night’s sleep:

“While zolpidem reduced mean awake time by 20 minutes compared to placebo on nights 1 and 2 of treatment, by days 15-16 efficacy was lost. After two weeks, the awake time difference from placebo was reduced to less than 3 minutes, a difference that was not statistically significant. The FDA nevertheless accepted this as evidence of efficacy when a post hoc analysis showed that if the measurement period for sleep was reduced from 8 hours to 6 hours, it yielded a reduction in awake time of 16 minutes compared to placebo. In patient assessments of the refreshing quality of sleep and subjective total sleep time, no statistically significant difference could be seen between placebo and drug treatment after two weeks of continuous use. The results were similar in a second pivotal trial of 6.25 mg in elderly patients.”

Zolpidem Adverse Reactions:

• Morning hangover, daytime drowsiness, dizziness, fatigue, driving difficulties
• Sleep walking, sleep driving, sleep sex
• Lightheadedness, accidents, falls
• Depression, suicidal thoughts, aggressiveness, hallucinations, memory loss, amnesia
• Headache, back pain
• Dry mouth
• Constipation
• Sore throat, sinusitis, flu-like symptoms
• Allergic reaction, skin rash
• Rebound insomnia, withdrawal symptoms

Sleeping Pill Side Effects Are Scary: Real Life Stories!

Over the last several years we have been collecting case reports about zolpidem’s side effects. Some people have no memory of sleep walking or sleep driving. Others have complained about memory problems. Severe heartburn is another complication we have heard about. Sadly, there is no mention of this adverse reaction in the official prescribing information so health professionals may not believe it is related to zolpidem.

Here are just a handful of stories reflecting the kinds of problems that have been reported to us.

Sleep Driving:

This comes from “Sad and Disappointed”:

“I am facing a DUI (Driving Under the Influence) charge from an accident I was never conscious for. My blood alcohol level was 0. I was not drinking! I have NO memory of this incident whatsoever.

“What I believe happened was this:

1. After a long day of moving out of my apartment I went to my friend’s house where I was staying in-between moving into a new place.
2. I took Ambien.
3. I jumped into the shower and was ready to go straight to bed
4. I ate something, fell asleep watching TV and
5. 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 the hospital released me and about a day later 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 cats.

“My life is not mine anymore. I suddenly face a DUI charge with a Public Defender assigned who couldn’t care less about me. How are you supposed to find a lawyer that really cares? I am 39 with absolutely NO RECORD but that apparently doesn’t stand for anything.”

Joe wrote:

“I got into my car after going to bed and drove into a parked car two blocks from my house. I then proceeded to get out, walk home and get back into bed. That is where the police found me.”

Memory Problems:

Joan stated:

“I have been using Ambien for years. My daughter blames my poor memory on it.”

Generic Zolpidem Effectiveness Issues:

N.R. shared:

“The generic Ambien did nothing for me. I had never taken a sleep aid and tried the generic. It was useless. The name brand did the trick. Only half a pill.”

This from Jane:

“I have been taking Ambien for 5 years and tried the generic. It did nothing. I also tried Ambien CR and it, too, was useless for me. Only brand name Ambien for me. If my doctor specifies ‘Brand name only’ on the Rx then I only have to pay $25.”

D.J. agreed:

“Without a doubt the generic Ambien does not work well. My doctor has to write name brand only and my mail-in pharmacy fills the prescription with Ambien CR 12.5 mg. I was so excited when I was given the generic brand. But it did not help me sleep at all.”

Heartburn:

C.H. had this experience.

“I have been taking zolpidem for almost 7 years. For the past year I have been taking one nightly. I started having problems with reflux, which I attributed to aging and stress. I am a medical professional and never thought the zolpidem might be a problem. Last week the problem became severe. My esophagus felt like I had eaten ground glass.

“I made an appointment with a GI doctor and took anything I could to alleviate the pain and associated symptoms. Tuesday night, I picked up the paper and read in your column about a person who experienced heartburn from zolpidem. I didn’t take a pill that night and haven’t for the past 2 nights. The reflux and pain have subsided with each day.

“Today I got up and had no pain and feel great. Thank you for all you do to show us the problems with medication that we health care professionals so freely give our patients.”

Share Your Own Story:

We have heard from many people who love Ambien (zolpidem) and swear that it is the only drug that works to put them to sleep. Others have shared some pretty scary side effects.

What about you? Tell us about your experience with sleeping pills in general or zolpidem in particular in the comment section below. You can also vote on this article. And if you would like to learn more about nondrug approaches to insomnia you may find our guide of interest: Getting a Good Night’s Sleep.