Rozerem is indicated for the treatment of insomnia
February 6, 2007 (Press Release) --
Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
Rozerem Precautions
Rozerem should not be used by patients with severe hepatic impairment, or in patients in combination with fluvoxamine. Rozerem has not been studied in subjects with severe sleep apnea or severe COPD and is not recommended for use in those populations. Patients should be advised to exercise caution if they consume alcohol in combination with Rozerem. Rozerem has been associated with decreased testosterone levels and increased prolactin levels. As a result, healthcare professionals should be mindful of any unexplained symptoms possibly associated with such changes in these hormone levels. Rozerem has not been studied in children or adolescents, and the effects in these populations are unknown.
Rozerem Directions
Rozerem should be taken within 30 minutes before going to bed and activities should be confined to those necessary to prepare for bed. Rozerem should not be taken with or immediately after a high-fat meal. Engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem should be avoided.
Rozerem Side Effects
The most common adverse events seen with Rozerem that had greater than 2% incidence difference from placebo were somnolence, dizziness, and fatigue.
Drug Interactions with Rozerem
Rozerem should not be used in combination with fluvoxamine.
Rozerem Precautions
Rozerem should not be used by patients with severe hepatic impairment, or in patients in combination with fluvoxamine. Rozerem has not been studied in subjects with severe sleep apnea or severe COPD and is not recommended for use in those populations. Patients should be advised to exercise caution if they consume alcohol in combination with Rozerem. Rozerem has been associated with decreased testosterone levels and increased prolactin levels. As a result, healthcare professionals should be mindful of any unexplained symptoms possibly associated with such changes in these hormone levels. Rozerem has not been studied in children or adolescents, and the effects in these populations are unknown.
Rozerem Directions
Rozerem should be taken within 30 minutes before going to bed and activities should be confined to those necessary to prepare for bed. Rozerem should not be taken with or immediately after a high-fat meal. Engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem should be avoided.
Rozerem Side Effects
The most common adverse events seen with Rozerem that had greater than 2% incidence difference from placebo were somnolence, dizziness, and fatigue.
Drug Interactions with Rozerem
Rozerem should not be used in combination with fluvoxamine.
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