Dangerous Sleeping Pills? FDA Issues Black Box Warning on Ambien & Other Insomnia Meds

The FDA just issued a black box warning on prescription insomnia medications, and millions of Americans are currently taking these dangerous sleeping pills. Here’s what healthcare professionals need to know.

50 to 70 million adults suffer from a sleeping disorder with insomnia being the most common. For years, the gold standard for insomnia treatment has included combined behavior therapy and pharmacotherapy. But now, healthcare providers might want to consider using non-pharmacologic strategies such as stimulus control therapy or cognitive therapies without prescribing dangerous sleeping pills. Here’s why… FDA Issues “Strongest Warning” on Insomnia Medications The U.S. Food and Drug Administration recently announced the agency is requiring a new boxed warning – the agency’s strictest and most prominent warning – on certain prescription insomnia drugs. First implemented in 1979, black box warnings highlight serious and sometimes life-threatening adverse drug reactions within the labeling of prescription drug products. Additionally, the FDA has issued a Contraindication for insomnia drugs – the strongest FDA warning – to avoid use in patients who have previously experienced an episode of complex sleep behavior. The new warnings are required for the most commonly-prescribed insomnia medications:

1. eszopiclone (Lunesta)
2. zaleplon (Sonata)
3. zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist)

According to the Addiction Center, approximately 38 million prescriptions were written for Ambien alone between 2006 and 2011. And, about 4 percent of all adults (20 years and older) in the United States used a prescription sleep medication in the past month, as reported by the Centers for Disease Control and Prevention. The FDA news release noted: “The black box warning follows several reports of rare but serious injuries and deaths resulting from various complex sleep behaviors after taking these medicines. The sleep behaviors include sleepwalking, sleep driving, and engaging in other activities while not fully awake, such as unsafely using a stove.” What makes sleeping pills so dangerous? Following a safety review of the FDA Adverse Event Reporting System and the medical literature, fatal injuries included carbon monoxide poisoning, drowning, falls, hypothermia, motor vehicle collisions with the patient driving, and suicide. Non-fatal serious injuries included accidental overdoses, falls, burns, near-drowning, exposure to extreme cold temperatures leading to loss of limb or near death, self-injuries such as gunshot wounds, and suicide attempts. Insomnia Drug Classifications Sleeping medications fall into a category of drugs known as hypnotics (or sedatives), which also includes benzodiazepines or benzodiazepine receptor agonists like Xanax. But, unlike other drugs in this category, sleeping pills are non-benzodiazepine hypnotics. They are commonly known as “z-drugs” since they induce sleep. What can healthcare professionals do? If your patient experiences short-term or chronic insomnia, encourage non-pharmacological treatment strategies before he or she is prescribed any of the aforementioned dangerous sleeping pills. Many behavior therapies have been developed to help patients resolve their sleep problems without the use of medications. These therapies are designed to help patients develop proper sleep habits. And studies have shown that these behavior therapies are just as effective as medical treatment for insomnia, with more sustainable results. Non-pharmaceutical approaches include:

• CBT Techniques
• Cognitive Therapy
• Stimulus Control
• Sleep Restriction
• Paradoxical Intention
• Correcting Breathing Patterns
• Sleep Hygiene Education

Proper sleep habits consists of:

• Avoid caffeine and nicotine before bedtime
• Avoid taking naps late in the afternoon
• Avoid eating a large meal before bedtime
• Avoid alcohol before bedtime
• Create a regular sleep schedule (going to bed and waking up at the same time each day)
• Avoid exercise within 4 hours of bedtime
• Make the bedroom quiet and dark
• Avoid cell phone use before bed
• Do not look at the clock throughout the night

Last, healthcare professionals can encourage the use of natural insomnia remedies such as over-the-counter melatonin or valerian root tea. To learn more, read the FDA Drug Safety Communication for healthcare providers here. References:

1. American Sleep Association: Sleep and Sleep Disorder Statistics
2. Addiction Center: Addiction to Sleeping Pills. Retrieved May 10, 2019.
3. Ann Indian Acad Neurol. 2010 Apr-Jun; 13(2): 94–102.
4. CDC: Prescription Sleep Aid Use Among Adults. Retrieved May 10, 2019.
5. Am Fam Physician.2009 Jan 15;79(2):125-130.