Pharmacy & Therapeutics - February 2008 - (Page 61)

Rozerem did not impair balance or memory in older adults† • Rozerem improves sleep in older adults, significantly reducing time to fall asleep and demonstrating sustained efficacy through 5 weeks 2 • Rozerem has not been shown to impair middle-of-the-night balance or memory in older adults with chronic insomnia compared with placebo†4 • A single 8-mg dose can be used safely in older adults 3 Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset. Rozerem can be prescribed for long-term use. Important Safety Information 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. Avoid taking Rozerem with alcohol. Rozerem has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms which could include cessation of menses or galactorrhea in females, decreased libido or problems with fertility that are 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. *Sustained efficacy has been shown over 5 weeks in clinical studies in adults and older patients.1, 2 †Patients should be advised to avoid engaging in hazardous activities (such as operating a motor vehicle or heavy machinery) after taking Rozerem.3 Please visit www.rozerem.com Please see adjacent Brief Summary of Prescribing Information. References: 1. Zammit G, Erman M, Wang-Weigand S, Sainati S, Zhang J, Roth T. Evaluation of the efficacy and safety of ramelteon in subjects with chronic insomnia. J Clin Sleep Med. 2007;3:495-504. 2. Roth T, Seiden D, Sainati S, Wang-Weigand S, Zhang J, Zee P. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med. 2006;7:312-318. 3. Rozerem package insert, Takeda Pharmaceuticals America, Inc. 4. Wang-Weigand S, Zammit G, Peng X. Placebo-controlled, double-blind trial examining the effects of ramelteon vs placebo with zolpidem as a reference on balance in older adults after middle-of-the-night awakening. Poster presented at: American Psychiatric Association Annual Meeting; May 19-24, 2007; San Diego, Calif. Poster NR604. Visit www.rx rozerem.com/olderadults to learn how Rozerem may be appropriate for a variety of patients with insomnia who have difficulty falling asleep. Rozerem™ is a trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals North America, Inc. http://www.rozerem.com http://www.rxrozerem.com/olderadults http://www.rozerem.com

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Pharmacy & Therapeutics - February 2008 Contents Editorial Medication Errors Prescription: Washington The Language of (Forgive Us) Change, As P&T Enters the Digital Age New Drugs/Drug News/New Medical Devices Drug Forecast Use and Outcomes of Antifibrinolytic Therapy in Patients Undergoing Cardiothoracic Surgery at 20 Academic Medical Centers in the United States Evaluation of the Management of Acute Venous Thromboembolism and Its Outcomes: One Institution's Experience American Society of Hematology, 49th Annual Meeting Pharmaceutical Approval Update

Pharmacy & Therapeutics - February 2008

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