Emergency Room Visits Resulting from Sleep Drug Skyrocket

The Substance Abuse & Mental Health Services Administration (SAMHSA) has released a report showing that emergency department (ED) visits resulting in whole or in part from the sleep drug zolpidem increased by nearly 220 percent over the period from 2005 to 2010. Zolpidem is an FDA-approved drug intended for the short-term treatment of insomnia and is an ingredient in brand-name drugs, including Ambien®, Ambien CR®, Edluar®, and Zolpimist®.  Although the drug remains approved, the report cautions that it should only be used on a short-term basis.

The DAWN Report

The Drug Abuse Warning Network (DAWN) is a surveillance system that monitors emergency department visits in the U.S. where drug use is a direct or contributing cause.  In 2010, there were 64,175 ED visits related to zolpidem; however, the DAWN report focused only on the 19,487 that were attributed to adverse reactions, as well as those that occurred from 2005 until that time.  Adverse reactions are those in which adverse health consequences resulted when taking prescription drugs, over-the-counter medications, or dietary supplements as prescribed or recommended.  Although some ED visits might have resulted from a combination of zolpidem and other drugs, the report did not consider instances in which zolpidem was combined with illegal drugs.  Adverse reactions to zolpidem include drowsiness, dizziness, hallucinations, behavioral changes, sleepwalking, and sleep driving (driving while not fully awake).

According to the report, women and the elderly were disproportionately the subject of ED visits resulting from adverse events.  Female ED visits increased overall by 274 percent from 2005 to 2010, although the results fluctuated from year to year.  In contrast, male ED visits increased by only 144 percent.  In 2010, 68 percent of all such ED visits involved females.  In 2010, 56 percent of all zolpidem-related adverse event ED visits involved patients 45 years old and above; of that group, 32 percent was comprised of patients aged 65 and older.

The majority of ED visits also involved a combination of zolpidem and another drug.  In 40 percent of all visits in 2010, zolpidem was the sole drug at issue.  However, 50 percent of cases involved a combination of drugs, such as pain relievers, antidepressants, or other anti-anxiety and insomnia medications; 10 percent involved zolpidem combined with alcohol only.

The report cautions that zolpidem should only be used as a short-term treatment for insomnia and underscores the importance of discussing the simultaneous use of other medications with physicians and pharmacists, noting that older adults, who commonly complain of insomnia, are often taking other prescription medications.  It also notes that the FDA has recommended for years that doses of zolpidem be cut in half for the elderly population, but that providers often continue to prescribe the medication in its full dosage.

Adverse Reactions, Complaints, and Actions

In January 2013, the FDA issued a  safety alert for zolpidem-containing products, recommending that providers cut women’s dosages in half and, in all cases, prescribe the lowest effective dosage.  The agency also focused on “day-after” symptoms that can result from extended release versions of the drug, reminding consumers and providers that patients can remain drowsy and impaired the following day.  The FDA made a distinction, however, between next-morning impairment and “complex sleep-related behaviors,” which can include walking, driving a car, preparing and eating food, making phone calls, and having sex, all without being fully awake.  At the time it released the safety alert, the agency had received 700 complaints of “impaired driving ability and/or road traffic accident,”  but specifically noted that it had little information about the dosages of zolpidem ingested, its combination use with other drugs, and other circumstances surrounding the accidents.  The FDA hoped that decreasing the prescribed dosage would alleviate complex sleep-related behaviors, as well as next-morning impairment.

Criticism of the drug has increased.  Indeed, there are websites devoted to the complex sleep-related behaviors that zolpidem can allegedly cause, ranging from binge eating (leading to weight gain) to driving infractions (leading to charges of disorderly conduct).  In nearly all cases, those affected claim to have no recollection of the activities.  As more information about zolpidem is released, defendants in drunk driving and other cases are increasingly using the drug’s effects as a defense, although a cursory review of information available online suggests that judges and juries are not taking it seriously.  Other consumers are suing Sanofi Aventis U.S., LLC, the manufacturer of Ambien and Ambien CR, the most well-known brand-name versions of the drug, for harm caused by ingesting the drug.  Again, many of these cases have not been successful.  Still, given the drug’s presence in the news and the release of the DAWN report, expect to see more lawsuits in the future.