Silenor belongs to a group of drugs called hypnotics.
Silenor is used to treat insomnia in people who have trouble staying asleep.
This medication guide provides information about the Silenor brand of doxepin. Sinequan and other generic brands of doxepin used to treat depression or anxiety are not covered in this medication guide.
Important information
You should not use Silenor if you have untreated narrow-angle glaucoma or severe problems with urination.
Do not use Silenor if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Silenor and talk with your doctor.
Before taking this medicine
You should not use Silenor if you are allergic to doxepin, or if you have:
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untreated narrow-angle glaucoma;
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severe problems with urination; or
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if you are allergic to antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine, imipramine, nortriptyline, protriptyline, or trimipramine.
Do not use Silenor if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
To make sure Silenor is safe for you, tell your doctor if you have:
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sleep apnea (breathing stops during sleep);
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a history of depression, mental illness, or addiction to drugs or alcohol;
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kidney or liver disease;
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diabetes (doxepin may raise or lower blood sugar); or
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if you have ever had glaucoma, or urination problems.
FDA pregnancy category C. It is not known whether Silenor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
See also: Pregnancy and breastfeeding warnings (in more detail)
Doxepin can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Do not give this medicine to a child without medical advice.
How should I take Silenor?
Take Silenor exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take this medicine within 30 minutes before bedtime. Do not take within 3 hours after eating.
It may take 7 to 10 days before your insomnia symptoms improve. Keep using as directed and call your doctor if your symptoms do not improve after 10 days of treatment.
Store at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Do not take Silenor if you do not have time for a full night"s sleep before being active again.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of doxepin can be fatal.
What should I avoid while taking Silenor?
Do not drink alcohol. Silenor can increase the effects of alcohol, which could be dangerous.
Silenor may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
To minimize the potential for next day effects, Silenor should not be taken within 3 hours of a meal.
Silenor side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Silenor: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
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fast, pounding, or uneven heart rate;
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confusion, hallucinations, unusual thoughts or behavior, seizure (convulsions);
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new or worsening symptoms of depression (mood or behavior changes, anxiety, trouble sleeping, feeling agitated, thoughts about suicide or hurting yourself.
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easy bruising or bleeding, unusual weakness;
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a light-headed feeling, like you might pass out;
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restless muscle movements in your eyes, tongue, jaw, or neck;
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tremors or uncontrollable shaking;
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little or no urinating; or
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extreme thirst with headache, nausea, vomiting, and weakness.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Silenor and talk with your doctor.
Common Silenor side effects may include:
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drowsiness, tired feeling;
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nausea;
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vision changes; or
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cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Silenor?
Taking Silenor with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking Silenor with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Before taking Silenor, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline.
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Silenor, especially:
This list is not complete. Other drugs may interact with doxepin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
