Drug Topics - March 2009 - (Page 28) Special Report COMPLEX SLEEP-RELATED BEHAVIOR 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.” For that reason, Helena Schotland, MD, a pulmonologist and director of sleep medicine services at Bryn Mawr Hospital in Pennsylvania, prefers the use of Rozerem, an FDA-regulated melatonin receptor agonist rather than OTC melatonin, a synthetic version of the natural hormone. organization dedicated to advancing sleep healthcare, makes the following recommendations for use of sleep medications: • Carefully read the package insert and all information provided by your physician and pharmacist outlining the drug’s safety, effectiveness, and side effects. • Ask your doctor about the intended use, dosage, and side effects. If you’re taking a sleep medication and problems arise, inform your doctor right away. • Strictly adhere to the indicated use of your sleep medication. Follow the prescription carefully and do not take more than the dosage your doctor prescribes. • To avoid morning or daytime drowsiness, when you use sleep medication allow sufficient time for a full night of sleep. • Avoid combining sleep medication with alcohol. • To avoid the possibility of adverse effects, make your doctor aware of any other medications you take — both prescriptions and OTC, including herbal products or natural foods, as many of these contain “active” ingredients. Make sure your provider knows about any other medical conditions you may have. Advice from the source The American Academy of Sleep Medicine, the largest professional membership On the horizon The sleep-disorder market soon may see the arrival of two insomnia drugs: doxepin (Silenor), from Somaxon, and eplivanserin from Sano -Aventis. The FDA review of doxepin was extended, with a new Prescription Drug User Fee Act of 1992 (PDUFA) date of February 29, 2009. Unlike existing sleep aids, doxepin selectively blocks the neurotransmitter histamine and may improve insomnia symptoms without serious adverse effects. Doxepin has been on the market for 35 years to treat anxiety and depression. Somaxon submitted its NDA under section 505(b)(2) of the Food, Drug and Cosmetic Act, which enables the company to rely on published literature of the FDA’s ndings on safety and ef cacy for other formulations of doxepin that have been previously approved by the agency. Eplivanserin is in a new nonsedating drug class known as antagonists of serotonin two A receptors (ASTARs). An independent trial using a 5-mg dose has shown that eplivanserin reduced the number of nocturnal awakenings by 64 percent compared to a 39 percent reduction with a placebo. In phase 3 trials, it has proved to be bene cial in maintaining sleep in those who awaken frequently and cannot fall back to sleep. At the end of December, the FDA approved Zolpimist, a prescription oral spray containing the active ingredient used in Ambien. Finally, Indiplon, which works similarly to Ambien and Lunesta, was set for approval in 2007 but has not yet been accepted by the FDA. W W W.D R U GTO P I C S .C O M 28 DRUG TOPICS March 2009 http://WWW.DRUGTOPICS.COM
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