Study Finds Unsafe Use of the Sleep Aid Zolpidem (Ambien)

Zolpidem (Ambien) was approved by the Food and Drug Administration (FDA) for the short-term treatment of insomnia characterized by difficulty initially falling asleep. It belongs to a family of drugs known as non-benzodiazepine hypnotics, which work similarly to benzodiazepines (diazepam, valium) — a class of drugs that target the brain to treat anxiety, depression and insomnia — but have a different chemical structure. We have designated zolpidem have risks of adverse effects far outweigh their benefits. There has long been evidence that zolpidem has been widely misused, and a recent study published in the Journal of the American Medical Association Internal Medicine (JAMA Internal Medicine) confirmed the frequent misuse of the drug for the treatment of insomnia.

Ambien (Zolpidem, Edluar, Intermezzo, Zolpimist) binds to a specific receptor in the brain to induce sleep. Research suggests that doctors often incorrectly perceive zolpidem as being safer and more effective for insomnia than benzodiazepines and, as a result, prescribe them more readily. However, like benzodiazepines, zolpidem is a controlled substance because it is habit-forming. Misuse of the drug can lead to serious adverse effects and dependence. A 2014 study published by researchers at the Centers for Disease Control and Prevention revealed that zolpidem was the most commonly implicated drug for emergency department visits for psychiatric drug-related adverse events among adults in the USA. One of the most troubling and dangerous adverse effects of zolpidem is next-day drowsiness and impairment, which can make it unsafe to drive or operate heavy machinery, leading to motor vehicle accidents. The drug also can cause abnormal thinking and behavioral changes, including aggressive or bizarre behavior, agitation and hallucinations.

Patients using zolpidem also can get out of bed without being fully awake and engage in activities, such as sleepwalking, sleep driving, sex and eating, without remembering such activities the following day. The risk of these adverse events increases if the zolpidem is taken with alcohol or other sedating drugs that depress the central nervous system (CNS). Zolpidem also can impair balance, which increases the risk of falls and injuries (including hip fractures), particularly in the elderly. Severe allergic and anaphylactic reactions also have been reported when taking this medication.

Importantly, the effectiveness of zolpidem decreases substantially after two weeks of continuous use. As with other habit-forming drugs, the body builds up tolerance to the effects of zolpidem, and individuals taking it for extended periods of time require higher doses to achieve the same desired effect. Furthermore, abrupt cessation after prolonged use of the drug can lead to rebound insomnia and serious withdrawal symptoms, including stomach cramps, nausea, vomiting, sweating, shakiness, irritability and craving for the drug. Despite these serious adverse effects, zolpidem is misused by a significant proportion of users. Finally, the study found that more than three-quarters of zolpidem users failed to adhere to two or more safety recommendations related to dosing, duration or concomitant medication use.

In conclusion, this study shows that the vast majority of patients prescribed zolpidem use it in a manner that greatly increases the risks of harm. Primary responsibility for these failures rests with the health care professionals who are recklessly misprescribing the drug. There are many steps you can take to sleep better and longer without resorting to drugs.

• Avoid the use of caffeine-containing products (including tea, coffee and chocolate), nicotine and alcohol, especially later in the day.
• Avoid heavy meals within two hours of bedtime.
• Avoid drinking fluids after supper to prevent frequent nighttime urination.
• Avoid environments that will make you active after 5 p.m. (for example, avoid noisy environments).
• Only use your bed for sleep. Sit in a chair when you just want to relax.
• Avoid watching television in bed.
• Establish a routine for getting ready to go to bed.
• Set time aside to relax before bed and use relaxation techniques.
• Create an atmosphere conducive to sleep
• Keep yourself at a comfortable temperature by modifying the number of blankets you use.
• Use earplugs to block out noise.
• Make the room darker if there is too much light.
• Replace the mattress on your bed if it is uncomfortable.
• When in bed, relax and think pleasant thoughts to help you fall asleep.
• Get up at the same time every day, including weekends. Use an alarm clock if necessary.
• Avoid taking daytime naps. If you have to take them, make sure that you do so before 3 p.m. and that the total time napping does not exceed one hour.

Do not suddenly stop taking sleeping pills without consulting your physician. Doing so carries a risk of severe withdrawal reactions.