FDA Investigates Next-Day Safety of Sleeping Pills

Allison Gandey

May 17, 2011

May 17, 2011 — The US Food and Drug Administration (FDA) is taking another look at the risks of sedatives and their link to next-day effects, such as dangerous sleep driving.

In a 2-day expert panel workshop, the agency and the Pharmaceutical Education Research Institute hosted the event that evaluated the efficacy and safety of sedative hypnotic drugs.

"New concerns have arisen about the most appropriate way to evaluate both the safety and the efficacy of medications for insomnia," the FDA told Medscape Medical News in an email, "particularly given that they may differ in important characteristics, including both pharmacodynamic and pharmacokinetic properties."

Sign on Interstate 15 in Utah

The products are used to induce or maintain sleep but have also been linked to serious falls and sleep-related behaviors, such as driving while not fully awake. Other behaviors include sleep walking, making telephone calls, and having sex. Most people do not remember these events afterward.

Allergic reactions can also be problematic with sedatives. "Severe allergic reactions can affect a patient's ability to breathe and can affect other body systems as well and can even be fatal," said Russell Katz, MD, the FDA's director of the Division of Neurology. "Although these allergic reactions are probably very rare, people should be aware that they can occur, because these reactions may be difficult to notice as people are falling asleep."

At the Tuesday, Wednesday workshop in Bethesda, Maryland, experts discussed the definition of insomnia, including major subtypes and symptoms. They also addressed patient selection for clinical trials and study endpoints and efficacy assessments.

The second day of the workshop was dedicated to discussions of safety and next-day function. According to the Centers for Disease Control and Prevention, drowsy driving contributes to an estimated 100,000 motor vehicle crashes and about 1500 deaths each year.

Drowsy driving contributes to an estimated 100,000 motor vehicle crashes and about 1500 deaths each year.

Meeting delegates had many questions. They wanted to know whether unsafe driving after sleeping pill use is linked to blood concentrations. They considered whether waiting a specific number of hours before operating a motor vehicle would be sufficient. And if so, how many hours — 8, 10? What might be the most prudent instruction to offer patients?

Attendees questioned whether patients taking sedatives should be tested the way drunk drivers are. Should devices similar to the breathalyzer be developed to test patients taking hypnotic drugs before they get behind the wheel? Experts weighed the pros and cons of the various options.

Meeting delegates pointed out that driving safety in patients with dementia is assessed using the Mini-Mental State Examination. Patients with scores of 24 or less are typically considered at increased risk for unsafe driving. However, guideline authors recommend that additional factors, such as driving history, visual defects, or mobility impairments, be taken into account.

This is not the first time these problems have been addressed. In 2007, the FDA requested that all manufacturers of sedative-hypnotic drugs include stronger product language warning of the potential risks.

The drugs involved are as follows:

  • Zolpidem tartrate (Ambien);

  • Pentobarbital and carbromal (Carbrital);

  • Flurazepam hydrochloride (Dalmane);

  • Quazepam (Doral);

  • Triazolam (Halcion);

  • Eszopiclone (Lunesta);

  • Ethchlorvynol (Placidyl);

  • Estazolam (Prosom);

  • Temazepam (Restoril);

  • Ramelteon (Rozerem);

  • Secobarbital sodium (Seconal);

  • Zaleplon (Sonata); and

  • Butisol sodium.

"After reviewing the available information on adverse events that occurred after the sedative-hypnotic drugs were on the market, FDA concluded that labeling changes were necessary to inform healthcare providers and consumers about risks," Steven Galson, MD, director of the Center for Drug Evaluation and Research, said in a news release at that time.

Many experimental medications for insomnia are currently in development. The FDA emphasizes the importance of considering both sleep latency and maintenance when making treatment decisions.

An estimated 50 million to 70 million Americans have chronic sleep and wakefulness disorders. Other FDA tips for better sleep are as follows:

  • Keep a regular sleep schedule at the same time every day;

  • Avoid caffeine, nicotine, and alcohol 4 to 6 hours before bed;

  • Don't exercise within 2 hours of bedtime;

  • Don't eat large meals within 2 hours of sleep;

  • Don't nap later than 3 pm;

  • Sleep in a dark, quiet room that isn't too hot or cold;

  • If you can't fall asleep within 20 minutes, get up and do something quiet; and

  • Wind down 30 minutes before bedtime by doing something relaxing.


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