How Safe Is Your Sleep Aid?

With as many as 70 million Americans suffering from insomnia, according to a 2007 report by the Institute of Medicine, the need for ZZZs has led to a booming market for a new class of non-narcotic sleep drugs, like Ambien, Lunesta and Sonata.

Americans spent almost $1.8 billion filling more than 16 million prescriptions for Ambien and Ambien CR last year, and almost $713 million on over 6 million prescriptions of Lunesta, according to Drug Topics digital magazine.

The new sleep aids fall into two classes — selective gamma-aminobutyric acid medications and sleep-wake cycle modifiers — and they have been billed as safer than the older class of sleep drugs, known as benzodiazepine drugs. The older drugs, which include Halcion, have been shown to be both habit-forming and addictive.

Still, the new drugs carry side effects that users should be aware of.

Addiction, sleep driving, sleep eating, and sleep sex are a few of the serious side effects reported by some patients who take the new medications.

But many doctors believe the most harmful aspect of these newer drugs is a potential overdose. Mixing them with other substances or taking doses exceeding a physician’s recommendation can result in over-sedation and death.

Such serious cases have occurred since these sleeping aids have been on the market, but they are more exposed by the media today, said Dr. Thomas Schwartz, associate professor of psychiatry at SUNY Upstate Medical Center in Syracuse, N.Y.

“We have known about these isolated cases of sleep driving, etc.,” he said. “The effect is the same if we went out and consumed too much alcohol. Overuse of alcohol may cause a blackout, which may be similar to the amnesia that modern day sleeping pills cause. Patients should be warned, but not scared out of taking an appropriate medication.”

New vs. Old

Although they have similar properties and are all legally classified as Class IV controlled substances, the newer sleep aids are not necessarily safer than benzodiazepines, which include Valium and Xanax, said Dr. Russell Katz, director of the Division of Neurology Products for the FDA’s Center for Drug Evaluation and Research.

All of the drugs, old and new, affect the GABA neurotransmitter receptor, which controls the central nervous system to promote drowsiness, but the older benzodiazepines also cause muscle relaxation and significantly decrease anxiety.

Heath Ledger was said to be using sleep aids in the days and months leading up to his death. The benzodiazepine sleep aid, Restoril, was one of the six drugs found in Ledger's bloodstream at the time of his death, which was ruled an accidental overdose.

Both the older and newer classes also have the potential for physical dependence, but the chance of becoming addicted is low when a patient takes the appropriate dose, medical professionals say. Mixing them with alcohol or other medications and going over a prescribed dose can be dangerous — even fatal.

What distinguishes the newer class of drugs from benzodiazepines is that patients usually do not build up a tolerance to them — often those taking benzodiazepines need to increase their dosage as time goes on. And once benzodiazepines are stopped, sleep problems can worsen.

Benzodiazepines also have been found to be respiratory suppressants, which slow breathing and can be dangerous when mixed with other respiratory suppressants like alcohol, while the newer class of medications doesn’t appear to pose these threats, said Matthew R. Ebben, an assistant professor of psychology in neurology and neuroscience at the Weill Medical College of Cornell University in Manhattan.

Respiratory suppression can be especially dangerous in long-acting drugs, which can continue to slow breathing long after the effects of the drugs can be felt. Some benzodiazepines, such as Halcion, are short-acting and only stay in a person’s system for a couple of hours while fellow benzodiazepine, Prosom is longer-acting.

Even though Ambien, Lunesta and Sonata are commonly prescribed by physicians, they still need to be taken with caution.

“Even though these are non-narcotic according to TV ads, they can be addictive and a person can abuse them the same way they can abuse (other substances),” Schwartz said. “A few extra, especially mixed with alcohol, could kill you.”

Ebben disagrees. He believes patients can develop a psychological dependence to the newer class of drugs, but not a physiological tolerance, that is why so many doctors prescribe the newer drugs.

Complex sleep behaviors occur only in a small percentage of those taking sleep aids, “but so many people do take them today that it can be a problem,” Ebben said.

Such strange side effects can go unnoticed by a patient unless a partner or housemate brings it to their attention or they leave evidence. This behavior occurs when a person is an altered state of consciousness being neither fully asleep nor fully awake.

According to Ebben, the best remedy for insomnia is behavioral treatment and that should come as the first course of action before medication. Those who suffer chronic insomnia should go to a behavioral sleep expert while anyone having isolated stress issues in their lives may consider medication.

Lifestyle modifications and behavioral treatments for sleep disorders may include relaxation training, cognitive therapy, stimulus control, sleep restriction therapy and sleep hygiene. Behavioral therapy is not a quick fix for a sleep problem and it requires steady practice over time, but it is an option for those who do not wish to take medications.

Based on the enormous growth of the sleep market, patients do not appear to be intimidated by the possibility of strange sleep behavior.

Use With Caution

Last year, the U.S. Food and Drug Administration requested that all manufacturers of sedative-hypnotic drug products — including sleep aids — strengthen their product labeling to warn patients of potential risks.

“As a general matter, these are benign treatments,” the FDA's Katz said. “Insomnia can be a common problem for people and I think these (medications) are effective and useful.”

The stronger labeling included the listing of risks such as severe allergic reactions and "bizarre complex sleep-related behaviors."

The FDA advises people who are treated with sleep aid products to take the following precautions:

— Talk to your health care provider before you start these medications and if you have any questions or concerns;

— Read the medication guide when taking the product;

— Do not increase the dose prescribed by your health care provider. Complex sleep-related behaviors are more likely to occur with higher than appropriate doses;

— Do not drink alcohol or take drugs that depress the nervous system;

— Do not discontinue the use of these medications without first talking to your health care provider.

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