As with all medications, Silenor has some side effects. It's important to know what they are and to talk with your healthcare provider about all the benefits and risks of taking Silenor.

The most common side effect of Silenor in patients included in the clinical studies was drowsiness or tiredness.

Do not take Silenor:

• with alcohol
• if you take other medicines that can make you sleepy. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take Silenor with your other medicines
• if you cannot get a full night of sleep before you must be active again

Do not take Silenor if you:

• take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI in the last 14 days (2 weeks). Ask your healthcare provider if you are not sure if your medicine is an MAOI
• have an eye problem called narrow angle glaucoma that is not being treated
• have trouble urinating
• are allergic to any of the ingredients in Silenor. Refer to the Medication Guide for a complete list of ingredients in Silenor.

After taking Silenor, you may get 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.

Before you take Silenor, tell your healthcare provider if you:

• have a history of depression, mental illness, or suicidal thoughts
• have severe sleep apnea
• have kidney or liver problems
• have a history of drug or alcohol abuse or addiction
• have a history of glaucoma or urinary retention
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Silenor will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant
• are breast-feeding or plan to breast-feed. Silenor can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Silenor. You should not breast-feed while taking Silenor

These are not all the side effects of Silenor. Ask your healthcare provider for more information. Please refer to the Medication Guide for complete information.

Silenor is a sleep medication available only by prescription. It is used to treat people with insomnia who have trouble staying asleep. Controlled clinical trials of Silenor demonstrated:

• No abuse potential or evidence of physical dependence/withdrawal symptoms
• No anticholinergic effects or weight gain versus placebo (sugar pills)
  • Anticholinergic side effects, such as constipation and urinary retention, have been associated with doxepin at doses higher than 6 mg
• No evidence of rebound insomnia

Silenor:

• Is only available in 3 mg and 6 mg tablets. The total daily dose should not exceed 6 mg. If you are taking Tagamet^® (cimetidine), the total daily dose should not exceed 3 mg.
• Should be taken within 30 minutes of bedtime. For faster onset and to minimize the potential for next-day effects, Silenor should not be taken within 3 hours of a meal.

Ask for Silenor by name. There is no generic Silenor.

Silenor is contraindicated in individuals who have shown hypersensitivity to doxepin HCl, any of its inactive ingredients, or other dibenzoxepines. Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors (MAOIs). Silenor should not be taken by patients who are currently on MOAIs or have taken MAOIs within the past two weeks. The exact length of time may vary depending on the particular MAOI dosage and duration of treatment.