Silenor approved for insomnia

The FDA has approved Silenor (doxepin tablets, from Somaxon Pharmaceuticals) for the treatment of insomnia characterized by difficulty with sleep maintenance. Silenor is not a controlled substance and will be available by prescription in 3mg and 6mg dosage strengths in the 2nd half of 2010.

What is the most important information I should know about SILENOR?
After taking SILENOR, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with SILENOR.

Reported activities include:

•   driving a car (“sleep-driving”)
•   making and eating food
•   talking on the phone
•   having sex
•   sleep-walking

Call your healthcare provider right away if you find out that you have done any of the above activities after taking SILENOR.

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 an 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, if you have severe sleep apnea or if you are allergic to any of the ingredients in Silenor. Until you know how you will react to Silenor, you should not drive or operate machinery at night after taking Silenor, and 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 http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Manufactured for:
Somaxon Pharmaceuticals, Inc.
San Diego, CA 92130 USA
This Medication Guide has been approved by the U.S. Food and Drug Administration.