Ambien now is known to cause adverse effects and its use may decreaseIn the early 1990s, word was spreading that Halcion, a popular short-acting sleeping pill prescribed for the treatment of insomnia, was a dangerous drug. Not only did it make users anxious, depressed, and suicidal.

It was also implicated in a series of murders. (The murderers were absolved of their crimes based on the argument that Halcion rendered people incapable of understanding their actions). Sales of Halcion plunged. Today the drug is still on the market but is rarely prescribed.

Now zolpidem (Ambien) is receiving intensive post-marketing scrutiny, raising questions about the drug’s safety. In January 2013 the Food and Drug Administration lowered the recommended dose for women and older adults from 10 mg to 5 mg following reports of zolpidem-related car crashes and an analysis linking the drug to drowsiness in the morning. Studies and reports published in the past 2 years cast more doubt on the drug’s safety. So is zolpidem now set to go the way of Halcion?

A Popular Sleeping Pill

About 5 million Americans now use medications containing zolpidem (generic zolpidem, Ambien, Ambien CR, Intermezzo, Edluar, and Zolpimist), according to the Institute for Safe Medication Practices. Like several other sleeping pills, zolpidem acts on GABA-producing neurons, helping tranquilize the brain.

Benzodiazepine drugs like Halcion bind to several kinds of GABA receptor complexes and consequently produce a range of adverse effects. Zolpidem binds more selectively. Early tests showed that it facilitated sleep and produced fewer adverse effects.

So the FDA in 1992 approved zolpidem for “short-term treatment of insomnia characterized by difficulties with sleep initiation.” FDA approval of the extended-release version came in October 2005—notably without the short-term restriction. Zolpidem in its many formulations dominated the hypnotics market for years despite occasional reports of people sleepwalking, sleep eating, and sleep driving under its influence.

A Troubling CDC Report

People with zolpidem-related problems and injuries were also showing up in hospital emergency departments. The Centers for Disease Control and Prevention recently reported on a survey of psychiatric medications identified as the reason for emergency department visits.

The results were surprising: of all psychiatric medications prescribed, zolpidem ranked first in adverse drug event cases. About 11.5 percent of all emergency department visits among adults were attributable to zolpidem, as were 21 percent of the visits in adults 65 and older. Authors of the report estimated that zolpidem accounted for 10,212 annual visits to hospital emergency departments, 25 percent of which required hospital admission.

Regular Users at Risk

Two new cohort studies suggest that it’s the regular users of zolpidem who are prone to serious accidents:

  1. In a study in Mayo Clinic Proceedings (May 2014), Taiwanese investigators found that long-term zolpidem use significantly increased the risk of major injuries requiring hospitalization. Depending on the dosage, users young and old were 2 to nearly 5 times as susceptible as nonusers to head injuries and fractures.
  2. In a large study in the American Journal of Public Health (August 2015), University of Washington researchers used new prescription and collision records to determine the relationship between the use of sleeping pills and motor vehicle crashes. Regular users of zolpidem were over twice as likely to have crashes as nonusers.

Some Perspective on the Problem

Why is a medication approved as safe and effective by the FDA causing so many problems? The Institute for Safe Medication Practices analyzed a 2012 health care survey to find out if zolpidem was being prescribed and used in a manner consistent with safe use guidelines. Here’s a summary of the report, which appeared in the May 6, 2015, issue of QuarterWatch:

  • Zolpidem was originally approved for short-term use only, yet 68 percent of the users with drug-related injuries or problems were long-term users of zolpidem, on average taking a pill about 2 nights out of 3.
  • Despite the FDA’s recent recommendation that women and older adults be prescribed the lowest approved dose of the drug (5 mg zolpidem or 6.25 mg extended release), in 2012 (before the recommendation came out), few people were taking the lower dose.
  • Drug-drug interactions were common among regular users of zolpidem. Prescribing information warns against taking other drugs that depress the central nervous system while taking zolpidem. Yet about 22 percent of regular zolpidem users were also using opioids on a sustained-use basis. About 23 percent were taking another drug (a benzodiazepine, pregabalin, or gabapentin) that, like zolpidem, acts on the GABA system, producing complex effects.
  • Finally, the prescribing information for zolpidem says the drug may worsen depression and suicidal thoughts in patients with depression. Yet 34 percent of the regular users of zolpidem were also using an antidepressant.

Many regular users of zolpidem may never experience drug-related complications. (This may also have been the case for the majority of Halcion users.) But with so much data now showing that zolpidem is causing harm to significant numbers of users, prescribing patterns will likely change. Don’t be surprised if the next time you ask for a renewal of your zolpidem prescription, you’re prescribed something else instead.

If you use zolpidem for insomnia, how do you feel about the possibility of losing access to this sleeping pill?

Posted by Lois Maharg, The Savvy Insomniac

Lois Maharg has worked with language for many years. She taught ESL, coauthored two textbooks, and then became a reporter, writing about health, education, government, Latino affairs, and food. Her lifelong struggle with insomnia and interest in investigative reporting motivated her to write a book, The Savvy Insomniac: A Personal Journey through Science to Better Sleep. She now freelances as an editor and copy writer at On the Mark Editing.

8 Comments

  1. I am dependent on Xanax, not Zolpidem, for sleep. It is a real problem that I can’t seem to overcome, even with medical assistance & therapy, though no one really seems to make a serious effort to help.
    I am seriously desperate for help to the point that I get suicidal frequently, as the sleep onset insomnia has lasted for years.
    The problem also exasperates a problem with adult ADD, which makes it seem impossible to get a handle on. The fatigue alone is something that I don’t know how to deal with and I know only makes me less inclined to do the things that I need to do to overcome the insomnia. An anxiety disorder only further complicates things…thus the Xanax.

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    1. Hello Jerry,

      I’m sorry to hear you’ve struggled for so many years with sleep onset insomnia. That’s the type I’ve struggled with too, so, believe me, I feel your pain.

      There are a few things in your comment that I want to respond to. Occasionally I use a sleeping pill to help me get to sleep, but I’ve never used them often enough to feel I was dependent on them. I’ve known people who have become dependent on sleep meds, though. Some are OK with it and some aren’t. It sounds like you’d like to find a way to get off Xanax.

      You mention that no one is making a serious effort to help you do that, or to help you with the insomnia. I do believe there are people out there who could help and who would care enough to want to help. It’s just a matter of finding the right doctor or therapist.

      When it comes to talk about insomnia, my personal experience with GPs and internists has been somewhat negative. The ones I’ve dealt with have never shown much empathy for my problem, and it seems that sleep disorders don’t get a lot of attention in medical schools, either. So I wound up feeling fed up with doctors and managing as best I could without them for many years.

      Then I started doing research on insomnia and writing my book, and I met quite a few sleep specialists in the process. I got a completely different sense about them. Unlike the GPs, they seemed to understand how debilitating insomnia can be, and they were able to propose better ways to manage it.

      In your case, you’ve got several things going on: the sleep onset problem, ADD, and an anxiety disorder. Obviously you’ve been to see doctors and therapists. But if you haven’t yet seen someone who specializes in treating sleep disorders, I would strongly recommend that you do that. There may be something going on that no professional has correctly diagnosed yet. And there may be better ways to treat the disorders that you have.

      The National Sleep Foundation has a site where you can go to find a sleep specialist:

      https://sleepfoundation.org/find-sleep-professional

      And here’s a place to look for behavioral sleep medicine specialists:

      http://www.behavioralsleep.org/findspecialist.aspx

      If you can’t find a sleep specialist in your area, I’ve got a list of providers myself and would be glad to help you locate someone. Just contact me through Ask The Savvy Insomniac or by clicking on “Contact” on the menu at the top of the page.

      I really do believe that help is out there and I hope you’re able to make the right connection soon.

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  2. I am 50 and have used Ambien for 8 years. I started not long after starting a stressful job and having a hysterectomy (ovaries not taken). I had a fall 2 years ago that lead to whiplash and brain injury. The pain, harrassment from work (because they didn’t believe I had such difficulties and needed to take time off), and financial difficulties, and possibly menopause made sleep difficult. I take 2-3 Norco a day and muscle relaxants. I am a PT and so I have tried all I could in that area. MDs and couselors didn’t seem to help but I hope I can find help with the references you gave. Money and insurance is difficult though.

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    1. Hi Jan,

      It sounds like you’ve got quite a few health challenges to deal with and, on top of them all, trouble sleeping. I, too, hope that you’re able to make contact with a sleep specialist or therapist on one of the lists I mentioned in my response above.

      If a consultation turns out to be too expensive, online programs for cognitive behavioral therapy (CBT) for insomnia might be more affordable. Find them at:

      http://www.sleepio.com
      http://www.myshuti.com
      http://www.cbtforinsomnia.com

      Books are more affordable still: The Insomnia Workbook, by Stephanie Silberman. The Insomnia Answer, by Glovinsky and Spielman. My book, The Savvy Insomniac, has a chapter on CBT for insomnia, chapter 8. It’s also got a chapter on current medications.

      Good luck whichever way you go.

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  3. I suffered from insomnia from age 14 to age 45. When I was young, I would be awake until 3 or 4am – fortunately, a local radio station played comedy albums during that time. When I was in the USMC, I could have a sergeant screaming into my face and I could fall asleep. In the Early ’80s, I could fall asleep while having a one on one meeting with my boss (even crushing my fingers with my teeth could not keep me awake). Finally, in 1995, a doctor prescribed Ambien and it changed my life. I have been on it mostly ever since. The only negative effect I have noticed is that I do not have the wonderful dreams – I dreamed science fiction, action adventure, and so on; I would actually look forward to napping so that I could dream. Now, not so much. I have no idea why I was insomniac; I have no idea why everyone thinks that I have a problem being on Ambien for so long

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    1. Hello Grumpy,

      The first thing I’ll say, reading about your situation, is that only you know your body well enough to understand what feels right and what doesn’t. If you sleep better at night and feel better during the daytime when you’re taking Ambien, and if your doctor continues to prescribe it, then, if I were you, I wouldn’t pay too much attention to what everyone else thinks.

      As I wrote above, in recent years, it’s become apparent that long-term use of Ambien and other so-called z-drugs can in some people have really adverse effects: falls requiring hospitalization, car crashes, sleep walking, and so forth. This is particularly true for older people who use these drugs. So, because a minority of users experience these negative effects, physicians typically adopt across-the-board policies that discourage prescribing these drugs to everyone.

      Anyway, coincidentally this morning I posted a blog on Australian and American attitudes toward sleeping pills. I quote another Ambien user whose views you may find quite similar to yours. Here’s the URL, if you haven’t seen the post yet:

      https://thesavvyinsomniac.com/sleeping-pills-too-risky-or-a-red-state-blue-state-affair/

      Thanks for writing in, and best of luck with your sleep.

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  4. I found this article while googling effects of long-term Ambien use. I feel that higher doses might indeed account for a higher risk of injury, however for me personally, a 5mg dose turned out to be a life-saver.

    I started Ambien in May and I saw a significant increase in my sleep quality, and by that I mean it takes me less than 30 minutes to fall asleep, whereas before it would take two hours or more every night. Some nights I have to take 7.5 or 10mg as I also suffer from unmedicated anxiety, which makes Ambien less effective. Even so, I feel no drowsiness or depresonalization the next day. I’m actually more confident to drive, go to the gym (where I do heavy weights exercises and MMA) and do other focus- and body-intensive things now that I’m not a sleep-deprived zombie functioning on three hours’ sleep. I’ve also not had any hallucinations or unexplained loss of memory. Of course this is just anecdotal evidence.

    If they took Ambien off the market, I’d personally be worried, as this is the only medication that has helped me so far without any pronounced side effects, and my doctor and I have tried lots of alternatives over the years.

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    1. Hello Liv Strong,

      I appreciate you taking time to describe your experience with Ambien. I’m glad it’s helping you sleep and find the stamina you need to work out at the gym.

      I use the drug occasionally myself and would feel resentful if it were taken off the market. But now I don’t see any signs that it will be taken off the market (nor was Halcion—or triazolam—ever taken off the market, although there were plenty of people who thought it should be and plenty of doctors who stopped prescribing it). Some physicians shy away from prescribing Ambien these days because of harmful side effects that have come to light in recent years.

      But you aren’t experiencing those side effects, and your doctor is evidently satisfied that the benefits of your taking Ambien outweigh the risks.

      Thanks for writing in!

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      Reply

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