Special Report: New Drugs and Treatments for Sleep Disorders

Article excerpt

In the early hours of a May morning in 2006, Rhode Island Congressman Patrick Kennedy drove his car into a security barrier near the Capitol. U.S. Capitol Police witnessed him swerving into the wrong lane and striking a curb. Kennedy claimed he could not recall the accident, but did remember taking a sleep aid and another prescription drug that can cause drowsiness. Congressman Kennedy is not the only person who has exhibited strange behavior under the influence of sleep medication.

Despite reports of individuals found sleepwalking, driving, eating, and even having sex - activities often forgotten due to temporary amnesia caused by sleep drugs - consumers don't seem to be alarmed about these medications.

As part of a new emphasis on medication therapy management, Joel Zive, PharmD, is in the habit of answering a lot of questions about drugs from patients, but for some reason, that's not his experience with prescription medications used to help people sleep.

"Most pa- tients picking up their prescrip- tions for medications just don't ask for much in- formation; they know what the drugs are for," said Zive, who joined the fam- ily pharmacy business in the Bronx. Zive Pharmacy employs four pharmacists and dispenses about 150 prescriptions a day.

If the prescription is new or the patient's profile indicates the pos- sibility of prob- lems with the drug, Zive will offer counseling. As a pharmacist, he also takes re- sponsibility for dispensing the most cost-ef- fective yet ap- propriate medi- cation and will turn to generics if a prescription does not desig- nate a brand and if patients are concerned about cost.

"There is a fine line between counseling a patient and reality," Zive said. "While I can tell them not to drive or operate heavy machinery if they take a sleeping pill, I can't scare them by informing them they could experience sleep-driving [driving with no memory of the event] or allergic reactions with sedative hypnotics, such as Zolpidem [Ambien]."

The patient medication guide contains warnings on these possibilities, but there are not enough statistics for Zive to bring it up, he said. His major concern is that his customers take these drugs appropriately. No matter what the drug, he said his job is to provide solutions."

In March 2007, the FDA requested label changes for all sedative hypnotic drug products to highlight risks such as severe allergic reactions and complex sleep-related behaviors. The FDA sent letters to manufacturers of the products, asking them to provide healthcare pro- viders with risk infor- mation and to develop patient medication guides for consumers. Medica- tions that fall under the warn- ing include butabarbi- tal, carbro- mal, estazolam, eszopiclone, ethchlorvynol, flurazepam, quazepam, ramelteon, secobarbital, temazepam, triazolam, zaleplon, and Zolpidem.

As with most drugs, sleep medications do not work effectively across the board; what's good for one person may not be the right medication for someone else. Some are more effective in inducing sleep; others maintain sleep or prevent awakening during the night. Some have a longer half-life, while others have a higher risk of becoming addictive. In addition, the dosage and length of time the drug may be used differ among individuals.

"Sleeping medications are more individualized these days," said Randy Vogenberg, chief strategic officer for Employer-Based Phar- maceutical Strategies LLC in Cranston, R.I., offering the example of Ambien CR, the extend- ed-release medication that helps patients not only fall asleep, but stay asleep. "A generic may work for one per- son, while a drug on the third tier may be better for someone else."

Pharmacists know the drill

Stephen Amira, PhD, associate psychologist at Boston's Brigham and Women's Hospital and an instructor at Harvard Medical School, believes many patients feel such desperation from insomnia that once they obtain a prescription, they feel reassured, anticipate relief, and find no need to ask questions about the drugs. …