A group of doctors is backing the FDA’s decision to require new warnings and lower dosages for Ambien and other sleep drugs, highlighting how consumers taking the drugs may not recognize that they are impaired before driving.
A perspective article published last week in the New England Journal of Medicine looked at the FDA’s recent decision to add new warnings and recommendation that doctors prescribe lower doses due to the potential risk of problems associated with lingering effects of Ambien and other sleep medications the following day.
In May, the FDA issued a drug safety communication to announce new label recommendations for drugs that use zolpidem as an active ingredient, including Ambien, Ambien CR , Edluar, and Zolpimist. The label changes cut the recommended dose of zolpidem for women from 10 mg to 5 mg for immediate release products, and from 12.5 mg to 6.25 mg for extended release products. The labels also warn patients who take the medications that they should not drive or engage in other activities requiring mental alertness the next day.
Concerns about the potential side effects of Ambien and related drugs came after several studies suggested that zolpidem blood levels in some patients remain high the morning after the sleeping pill is used, which can impair their ability to perform complex tasks.
The FDA used “quantitative analyses of the relationships among drug dose, blood levels and driving impairments” to highlight potential problems with Ambien and related drugs, the doctors wrote. The data showed that it stayed in the blood stream, particularly in women, even after an eight-hour sleep in many cases. This could lead to impaired driving or other activities and is a sign that too much of the active ingredient is loitering in the human body after a night’s rest.
The researchers said that the data is far more informative than looking at motor vehicle accident rates where the drug dosage, time of use of the sleep drug and the use of other drugs is not certain.
“It could be asked why the FDA did not leave the recommended doses unchanged and continue to warn patients to watch for driving impairment,” the doctors state. “A variety of new data have shown that people affected by impairment after taking zolpidem frequently do not recognize their impaired state; patient self-perception is not an adequate gauge for impairment.”
Zolpidem is a sedative-hypnotic medication used in adults to treat insomnia. The FDA warnings were issued earlier this year after findings from a driving simulation study revealed some individuals had blood levels in the morning containing zolpidem that were high enough to impair driving and increase the risk of a motor vehicle accident.
The FDA issued safety alert also emphasized drowsiness is listed as a common side effect for zolpidem and other sleep medications, along with drowsiness the day after taking the medication. However, the FDA also warned the medication may impair mental alertness, even if the user feels fully awake.
A study conducted by the Substance Abuse and Mental Health ervices Administration found that emergency room visits related to sleeping pill use has increased 220% from 2005 to 2010, meaning that nearly 20,000 people visited hospital emergency rooms due to injuries or side effects of Ambien or similar drugs in 2010, compared to only 6,000 in 2005.