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New Study Suggests no Significant Impairment in Middle-of-the-Night,Balance, Mobility or Memory in Older Adults Using Ramelteon

eep- wake cycle.

    * Ramelteon is not a controlled substance. A clinical abuse liability

      study showed no differences indicative of abuse potential between

      ramelteon and placebo at doses up to 20 times the recommended dose

      (N=14). Three 35-day insomnia studies showed no evidence of rebound

      insomnia or withdrawal symptoms with ramelteon compared to placebo

      (N=2082).

Important Safety Information

Ramelteon 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.

Ramelteon 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 ramelteon with alcohol. Ramelteon 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. Ramelteon should not be taken with or immediately after a high-fat meal. Ramelteon should be taken within 30 minutes before going to bed and activities confined to preparing for bed.

The most common adverse events seen with ramelteon that had at least a 2% incidence difference from placebo were somnolence, dizziness, and fatigue.

For complete Prescribing Information, visit www.ROZEREM.com.

Takeda Pharmaceuticals North America, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharm
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