Generic Name: doxepin (DOX-e-pin)
Brand Name: Silenor

Silenor is used for:

Treating insomnia (trouble sleeping) in patients who have trouble staying asleep. It may also be used for other conditions as determined by your doctor.

Silenor is a sleep medicine. Exactly how it works is not known. It is thought that Silenor works by blocking the effects of histamine in the brain. This helps you to stay asleep after you fall asleep.

Do NOT use Silenor if:

  • you are allergic to any ingredient in Silenor or to tricyclic antidepressants (eg, amoxapine)
  • you have untreated narrow angle glaucoma or severe trouble urinating
  • you have taken linezolid or a monoamine oxidase inhibitor (MAOI) (eg, furazolidone, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Need To Catch Some Shut-Eye? Tips on Getting the Sleep You Need

Before using Silenor:

Some medical conditions may interact with Silenor. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of mood or mental problems (eg, depression), suicidal thoughts or behaviors, or alcohol or substance abuse or dependence
  • if you have a history of glaucoma, kidney problems, liver problems, trouble breathing while asleep (sleep apnea), or trouble urinating
  • if you are taking a medicine that contains methylene blue

Some MEDICINES MAY INTERACT with Silenor. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Antifungal medicines (eg, fluconazole, terbinafine), carbamazepine, cimetidine, mibefradil, phenothiazines (eg, chlorpromazine, thioridazine), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, sertraline) because they may increase the risk of Silenor's side effects
  • Antiarrhythmics (eg, flecainide, propafenone, quinidine), anticoagulants (eg, warfarin), arsenic, astemizole, bepridil, chloroquine, cisapride, domperidone, halofantrine, ibutilide, iloperidone, macrolide antibiotics (eg, erythromycin), maprotiline, certain medicines for nausea (eg, dolasetron), methadone, paliperidone, pentamidine, pimozide, quinolone antibiotics (eg, levofloxacin), sulfonylureas (eg, tolazamide), sympathomimetics (eg, formoterol, pseudoephedrine), terfenadine, tetrabenazine, tramadol, tyrosine kinase inhibitors (eg, nilotinib), or ziprasidone because the risk of their side effects may be increased by Silenor
  • Linezolid or MAOIs (eg, furazolidone, phenelzine, rasagiline) because severe toxic effects may occur
  • Clonidine, guanadrel, guanethidine, or guanfacine because their effectiveness may be decreased by Silenor

This may not be a complete list of all interactions that may occur. Ask your health care provider if Silenor may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Silenor:

Use Silenor as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Silenor comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Silenor refilled.
  • Take Silenor at least 3 hours after your last meal.
  • Take Silenor by mouth within 30 minutes before bedtime.
  • After taking Silenor, limit your activities to those needed to prepare for bed.
  • Use Silenor only when you are able to get a full night's sleep (7 to 8 hours).
  • If you miss a dose of Silenor and you no longer have time for a full night's sleep, skip the missed dose. Do not take the dose in the morning or take 2 doses at once.

Ask your health care provider any questions you may have about how to use Silenor.

Important safety information:

  • Silenor may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Silenor with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using Silenor.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Silenor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Children, teenagers, and young adults who take Silenor may be at increased risk of suicidal thoughts or actions. Watch all patients who take Silenor closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Silenor may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Silenor. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Tell your doctor or dentist that you take Silenor before you receive any medical or dental care, emergency care, or surgery.
  • Do NOT use more than the recommended dose or for longer than prescribed without checking with your doctor.
  • If your symptoms do not get better within 7 to 10 days or if they get worse, check with your doctor.
  • Some patients taking Silenor have performed certain activities while they were not fully awake. These have included sleep-driving, making and eating food, making phone calls, and having sex. Patients often do not remember these events after they happen. Such an event may be more likely to occur if you use a high dose of Silenor. It may also be more likely if you drink alcohol or take other medicines that may cause drowsiness while you use Silenor. Tell your doctor right away if such an event happens to you.
  • Use Silenor with caution in the ELDERLY; they may be more sensitive to its effects.
  • Silenor should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Silenor while you are pregnant. Silenor is found in breast milk. If you are or will be breast-feeding while you use Silenor, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Silenor:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; behavior changes; confusion; fainting; fever, chills, or sore throat; hallucinations; memory problems (eg, memory loss); mental or mood changes (eg, aggression, agitation, anxiety, depression); panic attacks; severe headache or dizziness; suicidal thoughts or actions; unusual bleeding or bruising; worsening trouble sleeping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include agitation; confusion; dry mouth; enlarged pupils; fast or irregular heartbeat; flushing; hallucinations; loss of consciousness; numbness or tingling; seizures; severe dizziness; trouble urinating; uncontrolled muscle movements; unusual hair loss.

Proper storage of Silenor:

Store Silenor at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Silenor out of the reach of children and away from pets.

General information:

  • If you have any questions about Silenor, please talk with your doctor, pharmacist, or other health care provider.
  • Silenor is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Silenor or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Silenor. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Silenor. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Silenor.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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