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| Drug Uses Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the DEA. With the exception of Rozerem, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years. |
| How Taken 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. |
| Warnings 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. |
| Missed Dose If you miss a dose of Rozerem, simply wait until your next scheduled dose to take it again. |
| Side Effects The most common adverse events seen with Rozerem that had greater than 2% incidence difference from placebo were somnolence, dizziness, and fatigue. |
| Storage Store Rozerem in a cool, safe place at all times. |
| Overdose If you take too much ROZEREM or overdose, call your doctor or poison control center right away, or get emergency treatment. |
| More Info Rozerem should not be used in combination with fluvoxamine. |
| Disclaimer Please see your physician if you have any further questions about prescription drug Rozerem. |
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