Drug safety experts warn that most users of the sleep medications Ambien, Edluar and Zolpimist fail to use the drugs safely.
The Institute for Safe Medication Practices (ISMP) published a research letter this month in the medical journal JAMA Internal Medicine, indicating that more than three-quarters of Ambien (zolpidem) users do not adhere to FDA safety guidelines designed to prevent injuries and accidents due to drowsiness caused by the drug.
Amid increasing use of sleeping pills, concerns have emerged about potential side effects, including lingering effects of the medication the next day, which may result in drowsy driving accidents and other issues caused when individuals remain dangerously impaired. 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.
Additional 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.
According to the research letter, the FDA recommendations have gone largely unheeded. Researchers looked at data from the Medical Expenditure Survey Panel, which conducts an annual survey of medical care.
The ISMP’s findings indicate that 77% of users of Ambien, Edluar and Zolpimist, which all use the active ingredient zolpidem, failed to follow two or more FDA recommendations on using the drug safely. Most common unsafe use of the drugs involved taking two or more types at once, long-term use, and taking higher than recommended doses; particularly among women and older patients.
According to the findings, nearly 42% of users of Ambien and similar drugs combined the medication with another central nervous system depressant. More than a quarter of those were taking opioids, and just over 20% were taking benzodiazepines.
The ISMP first warned that Ambien safety issues were persisting in its 2015 QuarterWatch Report.
According to the ISMP report, the U.S. Centers for Disease Control and Prevention 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.
In 2014, the FDA received 1,030 serious adverse event reports where Ambien was the primary or secondary drug suspected of causing the problem.