Plain Talk About Insomnia Medications

Wednesday, March 1, 2006

Sleep ABZ’s: Plain Talk About Insomnia Medications (NAPSA)—Approximately 60 million people in the United States J suffer from insomnia, and nearly half of American adults report experiencing at least one symptom of insomnia at least a few nights a weekin the past year, yet the vast majority remains undiagnosed and untreated. Myths and misperceptions about insomniaandits treatment still persist that keep many sufferers from getting the sleep they need. Whenpeople do not get enough sleep, a “sleep debt” can accumulate, which can be difficult to catch up to if it becomes too big. The consequences of not getting enough sleep can include daytime fatigue, impaired mood, depression, decreased ability to concentrate and make decisions, and increased risk of additionalillness and injury. In fact, insufficient sleep has been associated with a variety of health problems, including obesity, diabetes, hypertension and heart disease. Adding to the problem, many people are reluctant to take sleep medications. According to a recent survey, about two in ten respon- dents said they assumed their sleep problems would go away naturally, or that they would ignore the problem anddo nothing aboutit. But ignoring the problem will not always makeit go away, and despite the fact that there are many new treatment options available for people living with insomnia, many misperceptions about insomnia treatment remain. This apparent confusion may cause some people to continue to needlessly suffer through sleepless nights. All prescription medications are associated with benefits and risks. Many commonly prescribed sleep aids are classified as controlled substances by the U.S. Drug Enforcement Administration (DEA), meaning, in part, that they carry some risk for abuse or dependence. “Non-narcotic medications may be controlled substances thatstill have some potential for addiction,” said Suzy Cohen, RPh, a pharmacist in Ocala, Florida. “Most insomnia medications work by acting widely throughout the central nervous system and, in some cases, can be associated with residual effects including next-day grogginess and memory impairment. Consumers who have concerns about these residual effects or the potential for abuse and dependence should talk with their doctor to find a treatment option that is best for their needs.” With one exception, all currently available prescription sleep treatments fall under the controlled substances umbrella. That exception is a medication called ROZEREM. (ramelteon), which works differently from other prescription sleep medications. It targets the brain’s own sleep-wake cycle and has not been associated with a risk of abuse or dependence or next-day hangover effects in clinical studies. RoZEREM is indicated for adults who have trouble falling asleep. The most common side effects seen with RoZEREM that were different from placebo (sugar pill) were sleepiness, dizziness and fatigue. People with insomnia mayfind it helpful to practice healthy sleep hygiene behaviors, such as avoiding naps, which can disturb the sleep-wake cycle; avoiding stimulants such as caffeine and nicotine close to bedtime; establishing a regular relaxing bedtime routine; avoiding large meals close to bedtime; and exercising regularly. No treatmentis right for everyone, and there are manytreatment options available for insomnia, so it is important for people to speak to their doctor to find a solution that worksbest for them. For more information about RozeEREM and full Prescribing Information, visit www.rozerem. com. Note to Editors: Important Prescribing Information: ROZEREM. (ramelteon) is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ROZEREM can be prescribed for long-term use. ROZEREM should not be used in patients with hypersensitivity to any components of the formulation, severe hepatic impairment, or in combination with fluvoxamine. Failure of insomnia to remit after a reasonable period of time should be medically evaluated, as this may be the result of an unrecognized underlying medical disorder. Hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression. ROZEREM has not been studied in patients with severe sleep apnea, severe COPD, or in children or adolescents. The effects in these populations are unknown. Exercise caution if consuming alcohol in combination with ROZEREM. ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms possibly associated with such changes in these hormone levels. ROZEREM should not be taken with or immediately after a high-fat meal. ROZEREM should be taken within 30 minutes before going to bed and activities confined to preparing for bed. The most common adverse events seen with ROZEREM that had at least a 2% incidence difference from placebo were somnolence, dizziness, and fatigue. For complete prescribing information, please visit www.rozerem.com.

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