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Silenor is a prescription sleep medicine that is used to treat people with insomnia who have trouble staying asleep.

IMPORTANT SAFETY INFORMATION

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Be sure that you are able to devote 7 to 8 hours to sleep before being active again. Silenor should be taken within 30 minutes of bedtime. Do not take with alcohol or with other medicines that can make you sleepy. If you are on a monoamine oxidase inhibitor (MAOI) or have taken a MAOI within the past two weeks, you should not take Silenor. You should not take Silenor if you have an eye problem called narrow angle glaucoma that is not being treated, if you have severe urinary retention, or if you are allergic to any of the ingredients in Silenor. You should not drive or operate machinery at night after taking Silenor. Until you know how you will react to Silenor, you should be careful in performing such activities during the day following taking Silenor. Before you take Silenor, tell your doctor if you have a history of depression, mental illness or suicidal thoughts. You should call your doctor right away if after taking Silenor you walk, drive, eat or engage in other activities while asleep. Drowsiness is the most common adverse event observed in clinical trials. For more information, please see the complete Prescribing Information, including the Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.