Silenor

Name: Silenor

Silenor Drug Class

Silenor is part of the drug class:

  • Non selective monoamine reuptake inhibitors

Silenor and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. 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.

Silenor Overdose

If you take too much Silenor, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Other Requirements

  • Keep Silenor and all medicines out of the reach of children.
  • Store Silenor tablets at 20°-25°C (68°-77°F).

What is the most important information I should know about doxepin (Silenor)?

You should not use this medicine if you have untreated narrow-angle glaucoma or severe problems with urination.

Do not use doxepin 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 doxepin and talk with your doctor.

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 other drugs will affect doxepin (Silenor)?

Taking doxepin with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking doxepin with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Before taking doxepin, 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 doxepin, especially:

  • cimetidine (Tagamet);

  • tolazamide (Tolinase); or

  • cold or allergy medicine that contains an antihistamine (such as Benadryl).

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.

Commonly used brand name(s)

In the U.S.

  • Silenor
  • SINEquan

Available Dosage Forms:

  • Capsule
  • Solution
  • Tablet

Therapeutic Class: Antidepressant

Pharmacologic Class: Antidepressant, Tricyclic

Uses For Silenor

Doxepin is used to treat anxiety or depression. It is also used to treat insomnia (trouble with sleeping).

Doxepin is a tricyclic antidepressant (TCA). It works on the central nervous system (CNS) to increase levels of certain chemicals in the brain.

This medicine is available only with your doctor's prescription.

Proper Use of doxepin

This section provides information on the proper use of a number of products that contain doxepin. It may not be specific to Silenor. Please read with care.

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using the Sinequan® oral liquid or capsule once a day, you may take it at bedtime.

To use the Sinequan® oral liquid:

  • Measure the dose with the calibrated dropper that comes with the medicine.
  • Mix each dose with about one-half glass (4 ounces) of water, whole or skimmed milk, orange juice, grapefruit juice, tomato juice, prune juice, or pineapple juice. Do not mix this medicine with grape juice or carbonated beverages (soda pop). Mix the medicine just before taking the dose. Do not prepare it ahead of time.

To use the Silenor® tablet:

  • Do not take this medicine within 3 hours of a meal. It may not work as well, or it might make you sleepy the next day if you take it with or right after a meal.
  • Take the tablet 30 minutes before going to bed, when you are ready to go to sleep.
  • Do not take the medicine unless you can get a full night's sleep (7 to 8 hours). If you wake up too soon, you may feel drowsy from the medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (capsules or solution):
    • For depression or anxiety:
      • Adults and children 12 years of age and older—At first, 75 milligrams (mg) once a day or in divided doses during the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day.
      • Children younger than 12 years of age—Use is not recommended.
  • For oral dosage form (tablets):
    • For insomnia:
      • Adults—6 milligrams (mg) once a day.
      • Older adults—At first, 3 mg once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Dosage and administration

The dose of Silenor should be individualized.

. Dosing in Adults

The recommended dose of Silenor for adults is 6 mg once daily. A 3 mg once daily dose may be appropriate for some patients, if clinically indicated.

. Dosing in the Elderly

The recommended starting dose of Silenor in elderly patients (≥ 65 years old) is 3 mg once daily. The daily dose can be increased to 6 mg, if clinically indicated.

. Administration

Silenor should be taken within 30 minutes of bedtime.

To minimize the potential for next day effects, Silenor should not be taken within 3 hours of a meal [see Clinical Pharmacology (12.3)].

The total Silenor dose should not exceed 6 mg per day.

Warnings and precautions

. Need to Evaluate for Comorbid Diagnoses

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Exacerbation of insomnia or the emergence of new cognitive or behavioral abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with hypnotic drugs.

. Abnormal Thinking and Behavioral Changes

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a hypnotic, with amnesia for the event) have been reported with hypnotics. These events can occur in hypnotic-naive as well as in hypnotic-experienced persons. Although behaviors such as "sleep-driving" may occur with hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with hypnotics appears to increase the risk of such behaviors, as does the use of hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Silenor should be strongly considered for patients who report a "sleep-driving" episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a hypnotic. As with "sleep-driving", patients usually do not remember these events. Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably.

. Suicide Risk and Worsening of Depression

In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of hypnotics.

Doxepin, the active ingredient in Silenor, is an antidepressant at doses 10- to 100-fold higher than in Silenor. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Risk from the lower dose of doxepin in Silenor can not be excluded.

It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

. CNS Depressant Effects

After taking Silenor, patients should confine their activities to those necessary to prepare for bed. Patients should avoid engaging in hazardous activities, such as operating a motor vehicle or heavy machinery, at night after taking Silenor, and should be cautioned about potential impairment in the performance of such activities that may occur the day following ingestion.

When taken with Silenor, the sedative effects of alcoholic beverages, sedating antihistamines, and other CNS depressants may be potentiated [see Warnings and Precautions (5.2) and Drug Interactions (7.3, 7.4)]. Patients should not consume alcohol with Silenor [see Warnings and Precautions (5.2) and Drug Interactions (7.3)]. Patients should be cautioned about potential additive effects of Silenor used in combination with CNS depressants or sedating antihistamines [see Warnings and Precautions (5.2) and Drug Interactions (7.4)].

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.

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