Safety and SILENOR®

SILENOR® is a sleep medication available only by prescription. It is used to treat people with insomnia who have trouble staying asleep.

As with all medications, SILENOR® has some side effects. The most common side effect of SILENOR® in patients included in clinical studies was drowsiness or tiredness.

To learn more about what you may expect when taking SILENOR®, read the following sections and talk with your healthcare provider about all the benefits and risks of taking SILENOR®.

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Learn more about sleep-maintenance insomnia and available resources.
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Safety Profile

SILENOR®

  • Is nonaddictive
  • May be used regularly
  • Is not a narcotic and is non-habit forming
  • Has no potential for abuse
  • Has side effects the morning after taking SILENOR® that are minimal and comparable to placebo (sugar pills) — even if you are age 65 or older

SILENOR® is a sleep medication available only by prescription. It is used to treat people with insomnia who have trouble staying asleep.

SILENOR®

  • Is approved to treat adult and elderly patients who have sleep-maintenance insomnia
  • Can be used to treat people with chronic sleep maintenance insomnia (insomnia lasting more than three weeks)
    • No restriction on duration of use
    • 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
  • Can be used to treat people with transient insomnia (short-term)
  • Is not a controlled substance
    • Has no abuse potential or evidence of physical dependence/withdrawal symptoms
  • Has a low rate of side effects
    • Drowsiness or tiredness was the most common side effect
  • Has no evidence of worsening of insomnia when you end use
  • 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

Talking

with your

doctor

Fill out this simple questionnaire to help you discuss your sleep with your doctor. It can help your doctor determine if SILENOR® is right for you.
> Learn more

How SILENOR® works

The science behind the sleep medicine.
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How safe is SILENOR®?

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 medications that can make you sleepy. Talk to your healthcare provider about all the medications you take. 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) medication 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 vs 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 (insomnia that returns after stopping use of a sleep medication)

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 MAOIs. SILENOR® should not be taken by patients who are currently on MAOIs 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.

Resources
for you!

Learn more about sleep-maintenance insomnia and available resources.
> Get going!

Taking SILENOR®

The science behind SILENOR®

Medication Guide

SILENOR® (SI-leh-nor) Tablets (doxepin)

Read this Medication Guide before you start taking SILENOR® and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

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:

  1. Take SILENOR® exactly as prescribed
    • Do not take more SILENOR® than prescribed.
    • Take SILENOR® 30 minutes before bedtime. After taking SILENOR®, you should only do activities needed to get ready for bed.
  2. 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
What is SILENOR®?

SILENOR® is a hypnotic (sleep) medicine that is used to treat people who have trouble staying asleep.

Who should not take SILENOR®?

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®. See the end of this Medication Guide for a complete list of ingredients in SILENOR®.

Talk to your healthcare provider before taking this medicine if you have any of these conditions.

It is not known if SILENOR® is safe and effective in children.

What should I tell my healthcare provider before taking SILENOR®?

Before you take SILENOR®, tell your healthcare provider if you:

  • See “Who should not take SILENOR®?”
  • 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®.

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

SILENOR® and other medicines may affect each other causing side effects. SILENOR® may affect the way other medicines work, and other medicines may affects how SILENOR® works. Especially tell your healthcare provider if you take:

  • a monoamine oxidase inhibitor (MAOI). See “Who should not take SILENOR®?”
  • cimetidine (Tagamet) or other medicines that can affect certain liver enzymes
  • certain allergy medicines (antihistamines) or other medicines that can make you sleepy or affect your breathing
  • the diabetes medicine tolazamide

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take SILENOR®?
  • Take SILENOR® exactly as your healthcare provider tells you to take it.
  • Your doctor will tell you how many SILENOR® to take and when to take them.
  • Your doctor may change your dose if needed.
  • Take SILENOR® within 30 minutes of bedtime. After taking SILENOR®, you should confine your activities to those necessary to prepare for bed.
  • Do not take SILENOR® within 3 hours of a meal. SILENOR® may not work as well, or may make you sleepy the next day if taken with or right after a meal.
  • Do not take SILENOR® unless you are able to get a full night of sleep before you must be active again.
  • Call your doctor if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
  • If you take too much SILENOR®, call your doctor or get medical help right away.
What should I avoid while taking SILENOR®?
  • You should not drink alcohol while taking SILENOR®. Alcohol can increase your chances of getting serious side effects with SILENOR®.
  • You should not drive, operate heavy machinery, or do other dangerous activities after SILENOR®.

You may still feel drowsy the next day after taking SILENOR®. Do not drive or do other dangerous activities after taking SILENOR® until you feel fully awake.

What are the possible side effects of SILENOR®?

SILENOR® can cause serious side effects including:

  • See “What is the most important information I should know about SILENOR®?”

The most common side effect of SILENOR® is drowsiness or tiredness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SILENOR®. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store SILENOR®?
  • Store SILENOR® between 68° and 77°F (20° to 25°C).
  • Keep SILENOR® in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.
  • Keep SILENOR® and all medicines out of the reach of children.

General Information about SILENOR®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SILENOR® for a condition for which it was not prescribed. Do not share SILENOR® with other people, even if you think they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about SILENOR®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about SILENOR® that is written for healthcare professionals.

For more information, contact Pernix Therapeutics, LLC. at 1-877-SILENOR (745-3667) or visit http://www.silenor.com.

What are the ingredients in SILENOR®?

Active Ingredient: doxepin hydrochloride

Inactive Ingredients: Microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate. The 3 mg tablet also contains FD&C Blue No. 1. The 6 mg tablet also contains FD&C Yellow No. 10 and FD&C Blue No. 1.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

  • SIL-0030.02.P1A

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.