Sleep disorder drugs require patient counseling

Key Points

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.

If the prescription is new or the patient's profile indicates the possibility of problems with the drug, Zive will offer counseling. As a pharmacist, he also takes responsibility for dispensing the most cost-effective yet appropriate medication and will turn to generics if a prescription does not designate 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 providers with risk information and to develop patient medication guides for consumers. Medications that fall under the warning include butabarbital, carbromal, 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.

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. "Once at the pharmacy, they are feeling such urgency that they are not looking for any reasons to dissuade them from their choice to take the drug," Amira said.

From his vantage point as a psychologist associated with several sleep clinics affiliated with the Harvard health system, he said he recognizes the importance of patients consulting with a professional before they start a prescription and submitting to a follow-up to ensure the medication is working effectively. Since he is not a psychopharmacologist, he readily refers patients to a pharmacist for advice and for better understanding of each sleep drug. "Pharmacists serve as a really good resource," he said. "They can give appropriate information so that patients can make the right decisions."

LeAnn Causey-Boyd, PharmD, interacts with consumers when they pick up their prescriptions for sleep medication at Causey's Pharmacy in Natchitoches, La., where she serves as director of clinical services. She makes a point of offering basic counseling if the drug is new to a patient. "But a well-known drug like Ambien usually generates few questions," she said.

"If a doctor recommends taking one or two pills, we explain what might work best for the patient. We are also on hand to discuss how different treatments work more effectively for specific problems – falling asleep, waking up with trouble falling back to sleep," she said. If necessary, she will recommend that patients discuss concerns with their doctors. She said it is important for patients to explore the underlying cause of insomnia before getting a prescription.

Convinced that consumers don't read the entire label on a drug prescription, Leonard Edloe, PharmD, owner/pharmacist of Edloe's Professional Pharmacy in Richmond, Va., accepts the opportunity to counsel patients about sleep drugs. And if they do read labels, he is still concerned the label does not caution users against taking the drugs every night. One of the biggest problems he confronts is consumers coming in early for refills.

Edloe considers his pharmacy to be a community health center; he knows the majority of his customers, mostly elderly people taking many medications, and whose incomes are limited. He said many of his customers cannot read or write, so face-to-face communication is even more important. "I know I can help people by discussing their problems with prescriptions. I don't want the medications to just become a commodity," he said. He works to maintain a high profile with his own newsletter and call-in radio show, so that customers will feel comfortable about asking for advice.

"Sleep medications should not make you feel worse; they are designed to make you feel better," said Ronald Kramer, MD, a Denver neurologist and regional spokesman for the American Academy of Sleep Medicine (AASM). "They are not acceptable if the situation is less than that."

The downside of OTC/herbal sleep medications

The real growth in sleep aids over the next 10 years will be in nonprescription, over-the-counter medications (OTC) and herbal supplements, according to research company Packaged Facts. Sales of these sleep aids will increase to nearly $760 million in sales by 2013; the OTC market accounted for $604 million in sales in 2008.

The FDA, which does not approve OTC sleep medications, believes they don't have the same level of precision as prescription drugs and don't completely stop working after eight hours, making many people feel drowsy the next morning. The agency warns users to read product labels and to exercise caution when taking OTC sleep aids until they learn how these products will affect them.

Herbal products also have not undergone the same rigorous testing as prescription drugs; the effectiveness and safety of these products have not been similarly documented or have the contents been scrutinized so closely, according to the American Insomnia Association.

Kramer said that the "scientific" position on OTC sleep aids is that insufficient data are available and "there is no reason to think they are safer than prescription drugs."

Advice from the source

The American Academy of Sleep Medicine, the largest professional membership organization dedicated to advancing sleep healthcare, makes the following recommendations for use of sleep medications: