FIRST IN A NEW CLASS OF SLEEP AGENTS INTRODUCING ROZEREM— ZERO EVIDENCE OF ABUSE OR DEPENDENCE Clinical trials show no evidence of potential abuse* dependence, or withdrawal • First and only—nonscheduled prescription insomnia medication...not a controlled substance and approved for long-term use • First and only—prescription insomnia medication that targets the normal sleep-wake cycle’ • First and only—prescription insomnia medication with no evidence of abuse potential in clinical trials • First and only—prescription insomnia medication that does not act by CNS depression1 • Promote sleep with Rozerem—patients who took Rozerem fell asleep faster than those who took placebo1 Please visit www.rozerem.com *A randomized, single-center, double-blind, dose run-up study (N=6) and a single-center, randomized, double-blind, placebo-controlled crossover study (N-14) specifically assessed the abuse liability of Rozerem in patients with a history of substance abuse.*' Rozerem 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 greater than 2% incidence difference from placebo were somnolence, dizziness, and fatigue. Please see adjacent Brief Summary of Prescribing Information. NEW ORozerem ram efteon 8-mg tablets Provenfo r sleep. Nonscheduledforadded safety. Rozerem ■.is a trademark of Takeda Pharmaceutical Company Limited and used under license by Takeda Pharmaceuticals North America, Inc. 183
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