Despite recent efforts to increase the safety of the sleeping pill Ambien, the drug continues to be linked to more emergency department visits than any other medication, mainly due to inappropriate or unsafe use, according to a new report. 

Concerns about the safety of Ambien (zolpidem) were highlighted in the most recent issue of QuarterWatch, published last week by the Institute of Safe Medication Practices (ISMP).

The report found that the clinical trials used to approve Ambien for use by consumers did not match it’s likely use patterns, leaving little data about the risks associated with taking the drug long-term and use by those with mental illness or taking other psychoactive drugs.

According to the ISMP report, the U.S. Centers for Disease Control and Prevention (CDC) found that Ambien and its generic zolpidem equivalents were the drug most linked with emergency room visits, according to adverse event data received by the FDA. According to the report, there are an estimated 10,2112 emergency department visits each year linked to Ambien use, with 25% of those requiring the person be hospitalized.

The findings are similar to those of an Ambien injury study published last year by the Substance Abuse and Mental Health Services Administration (SAMHSA). According to that group’s findings emergency room visits involving side effects of Ambien increased from 21,824 in 2005 to 2006, up to more than 42,000 in 2009 to 2010.

In 2014, the FDA received 1,030 serious adverse event reports where Ambien was the primary or secondary drug suspected of causing the problem.

“Our analysis showed most zolpidem use was not in accord with safety recommendations,” the ISMP report states. “Zolpidem is recommended for short-term use, based on pivotal efficacy trials of 21-37 days. We found 68% of zolpidem patients were sustained users, with 3 or more prescriptions/refills and a mean of 229 days supply.”

The most common even reported was suicidal or self-injurious behavior, followed by not only reports of patients walking in their sleep, but also of driving, eating and having sex. At least two murders occurred after the murderers took Ambien and claimed they could not recall killing their victims, both of which were spouses.

Despite neither suspect having a history of violence, both taking Ambien and Paxil at the same time, and both complaining of memory gaps about the incident, both were still convicted.

Insufficient Clinical Trials

According to the ISMP report, one of the reasons the FDA and the medical community may have been blind-sided by the side effects of Ambien is because of the limited clinical trials used to gain its approval.

According to the report, the clinical trial for extended release formulation lasted just 21 days. the trial for the original immediate release version only observed patients on the drug for 37 days. that compares with the report’s findings that many take the drug for as long as 229 days.

The clinical trials also did not look at the effects on patients with mental illness or those already taking other psychoactive drugs. Both groups are considered more likely to need sleeping aids than the general population.

Even in those trials, ISMP points out, efficacy dropped after about two weeks of use to the point where it had little more effect than a placebo.

“The safety profile of zolpidem today illustrates major shortcomings in the system intended to ensure the safe use of therapeutic drugs,” the report concludes. “The pattern of actual use, as measured here, is markedly different from the conditions under which the drug was tested.”

Lingering Ambien Side Effects

Amid increasing use of sleeping pills, concerns have emerged about problems that may be caused by lingering effects of the medication the next day, including drowsy driving accidents and other issues caused when individuals remain dangerously impaired the next day. Several reports suggest that women may be more susceptible to these problems, but all individuals required to perform tasks requiring high levels of alertness may be at risk.

In January 2013, the FDA issued a safety alert indicating that recommended Ambien doses should be lowered, cutting the recommended dose for women in half, and indicated that doctors should prescribe all patients the lowest dose possible to treat the symptoms.

New warnings for Ambien, Zolpimist and other zolidem sleeping pills were approved by the FDA in May 2013, indicating that users should not drive or engage in other activities requiring mental alertness the next day after taking the medication.

In May 2013 the FDA approved a new warning label for sleeping pills like Ambien and Zolpimist. The warnings recommended lower doses to reduce the risk of experiencing lingering side effects the following morning after taking the drug.

A study published in August 2013 backed the FDA’s decision to cut doses of Ambien and other sleeping drugs, concluding that individuals taking the sleeping pills may not recognize their level of impairment the following day before driving or completing other complex tasks.

Researchers said levels of the drugs remain in the blood stream for more than an eight-hour sleep and stay high in the morning. This impairs the ability to perform certain tasks, but also impairs the users judgment whether they are still under the influence of the drug.

According to a report published in the British Medical Journal in 2012, people who take Ambien or other sleeping pills are five times for likely to die within two and a half years than someone who does not take sleeping pills. The study also revealed sleeping pill users may also face an increased risk of developing cancer.

Health experts estimate six to 10 percent of the adult population used sleeping pills in 2010, making them one of the most widely used classes of drugs in the U.S.

According to the ISMP there were 40 million dispensed prescriptions for Ambien in 2013, the vast majority of those were for the pills in their generic form.

Tags: Ambien, Clinical Trials, Drug Side Effects, Sleep Driving, Sleep Walking, Sleeping Pill