How much doxepin for sleep?

Doxepin (Sinequan)

Generic Name: doxepin (Sinequan) (DOX e pin)
Brand Name:

Medically reviewed by Drugs.com on Jul 18, 2019 – Written by Cerner Multum

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What is doxepin (Sinequan)?

This medication guide provides information about the use of doxepin (Sinequan or other generic names) to treat depression or anxiety. Silenor is another brand of doxepin that is not covered in this medication guide.

Doxepin is a tricyclic antidepressant that affects chemicals in the brain that may be unbalanced.

Doxepin (Sinequan or other generic name) is used to treat symptoms of depression and/or anxiety associated with alcoholism, psychiatric conditions, or manic-depressive conditions.

Doxepin may also be used for purposes not listed in this medication guide.

Important Information

You should not take doxepin if you have glaucoma or problems with urination. Do not use if you are allergic to doxepin or to similar antidepressants.

Do not use doxepin if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not give this medicine to anyone under 18 years old without the advice of a doctor. Doxepin is not approved for use in children.

Before taking this medicine

You should not use doxepin if you are allergic to it, or if you have:

  • glaucoma;

  • urination problems; or

  • an allergy to similar antidepressants such as amitriptyline, amoxapine, clomipramine, desipramine, imipramine, nortriptyline, protriptyline, or trimipramine.

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.

To make sure doxepin is safe for you, tell your doctor if you have:

  • sleep apnea (breathing stops during sleep);

  • diabetes (doxepin may raise or lower blood sugar); or

  • bipolar disorder (manic-depression).

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using doxepin. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether doxepin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to anyone under 18 years old without the advice of a doctor. Doxepin is not approved for use in children.

How should I take doxepin (Sinequan)?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take doxepin in larger or smaller amounts or for longer than recommended.

Measure doxepin oral concentrate (liquid) with the special dose-measuring dropper provided. Do not use a regular table spoon. If you do not have a dose-measuring dropper, ask your pharmacist for one.

Empty the measured dose from the medicine dropper into a small glass (4 ounces) of water, milk, orange juice, grapefruit juice, tomato juice, prune juice, or pineapple juice. Do not use grape juice or a carbonated soft drink to mix doxepin oral concentrate. Stir the mixture and drink all of it right away. Do not save it for later use.

Do not stop using doxepin suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using doxepin.

It may take up to 3 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

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.

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 doxepin (Sinequan)?

Do not drink alcohol. Doxepin can increase the effects of alcohol, which could be dangerous.

Doxepin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Doxepin (Sinequan) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain or swelling, seeing halos around lights;

  • a light-headed feeling, like you might pass out;

  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

  • tremors, restless muscle movements in your eyes, tongue, jaw, or neck;

  • confusion, hallucinations, unusual thoughts, seizure (convulsions); or

  • painful or difficult urination, urinating less than usual.

Common side effects may include:

  • drowsiness;

  • vision changes;

  • nausea, vomiting, diarrhea, indigestion, loss of appetite;

  • dry mouth, mouth sores, taste problems;

  • breast swelling (in men or women); or

  • decreased or increased sex drive.

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.

What other drugs will affect doxepin (Sinequan)?

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.

You must wait at least 5 weeks after stopping fluoxetine (Prozac) before you can take doxepin.

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. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 12.01.

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  • Drug class: miscellaneous anxiolytics, sedatives and hypnotics
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Consumer resources

  • Doxepin Tablets
  • Doxepin Capsules
  • Doxepin Oral Concentrate
  • Doxepin (Advanced Reading)

Other brands: Silenor, Sinequan

Professional resources

  • Doxepin Hydrochloride (AHFS Monograph)
  • … +5 more

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Doxepin (Insomnia)

Before taking doxepin (Silenor),

  • tell your doctor and pharmacist if you are allergic to doxepin (Silenor), amoxapine, loxapine, any other medications, or any of the ingredients in doxepin (Silenor) tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Also tell your doctor if you are taking or receiving methylene blue (Provayblue) or linezolid (Zyvox). Your doctor will probably tell you not to take doxepin. If you stop taking doxepin, you should wait at least 14 days before you start to take an MAO inhibitor.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: cimetidine (Tagamet); medications for cough, cold, or allergies; quinidine (in Nuedexta); sedatives; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); other sleeping pills; tolazamide; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with doxepin (Silenor), so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor if you have or have ever had glaucoma that is not being treated, or urinary retention (inability to empty your bladder completely or at all). Your doctor may tell you not to take doxepin (Silenor).
  • tell your doctor if you have or have ever drunk large amounts of alcohol, used street drugs, or over-used prescription medications. Also tell your doctor if you have or have ever had depression, mental illness, suicidal thoughts, sleep apnea (a sleep disorder that causes breathing to stop for short periods during sleep), or kidney or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking doxepin (Silenor), call your doctor.
  • you should know that doxepin (Silenor) may make you drowsy. Do not drive a car, operate machinery, or do other dangerous activities at night after taking doxepin (Silenor). Do not drive a car or operate machinery the next day until you know how this medication affects you.
  • you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while you are taking doxepin (Silenor).
  • you should know that some people who took doxepin (Silenor) got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, were sleep-walking, or were involved in other activities while not fully awake. After they woke up, these people were usually unable to remember what they had done. Call your doctor right away if you find out that you have been driving or doing anything else unusual while you were sleeping.

Sinequan

Brand Names: Adapin, SINEquan

Generic Name: doxepin (Sinequan)

What is doxepin (Sinequan) (Adapin, SINEquan)?

This medication guide provides information about the use of doxepin (Sinequan or other generic names) to treat depression or anxiety. Silenor is another brand of doxepin that is not covered in this medication guide.

Doxepin is a tricyclic antidepressant that affects chemicals in the brain that may be unbalanced.

Doxepin (Sinequan or other generic name) is used to treat symptoms of depression and/or anxiety associated with alcoholism, psychiatric conditions, or manic-depressive conditions.

Doxepin may also be used for purposes not listed in this medication guide.

What are the possible side effects of doxepin (Sinequan) (Adapin, SINEquan)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain or swelling, seeing halos around lights;
  • a light-headed feeling, like you might pass out;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • tremors, restless muscle movements in your eyes, tongue, jaw, or neck;
  • confusion, hallucinations, unusual thoughts, seizure (convulsions); or
  • painful or difficult urination, urinating less than usual.

Common side effects may include:

  • drowsiness;
  • vision changes;
  • nausea, vomiting, diarrhea, indigestion, loss of appetite;
  • dry mouth, mouth sores, taste problems;
  • breast swelling (in men or women); or
  • decreased or increased sex drive.

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.

What is the most important information I should know about doxepin (Sinequan) (Adapin, SINEquan)?

You should not take doxepin if you have glaucoma or problems with urination. Do not use if you are allergic to doxepin or to similar antidepressants.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Do not give this medicine to anyone under 18 years old without the advice of a doctor. Doxepin is not approved for use in children.

Doxepin 25Mg Capsule

Doxepin 25Mg Capsule is an antidepressant used to treat mental or mood problems such as insomnia, depression and anxiety. It helps improve mood and instil feelings of well-being, it relieves anxiety and tension, helps you sleep better and more peacefully, and increases your energy level. This medication is part of a class of medications called tricyclic antidepressants, which works by affecting the balance of certain natural chemicals called neurotransmitters in the brain and nervous system.

Some side effects of Doxepin 25Mg Capsule may include dizziness, blurred vision, drowsiness, and dry mouth, trouble in urinating or constipation. To relieve dizziness, get up slowly from or a lying or sitting position. Suck on ice chips, chew gum or drink water to relieve dry mouth. Adjust your diet to prevent constipation. Include plenty of water and fibre into your diet and exercise regularly. If any of these symptoms persist, consult your doctor immediately. In case of overdose, a hospital should be contacted. Some symptoms of overdose may include extreme drowsiness, hallucinations, fast or irregular heartbeat, fainting, slow or shallow breathing and seizures. This medication should not be taken by people who have been allergic to any ingredient of Doxepin 25Mg Capsule or to other trycyclic antidepressant medicines like amoxapine and have narrow angle glaucoma that is untreated or have serious trouble urinating.

Information given here is based on the salt content of the medicine. Uses and effects of the medicine may vary from person to person. It is advisable to consult a Psychiatrist before using this medicine.

Doxepin 6 Mg Tablet Hypnotics

Side Effects

Drowsiness or nausea may occur. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake (“sleep-driving”). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking doxepin.

At higher doses, doxepin is used to treat a variety of other conditions, including depression and other mental/mood disorders. It can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition. Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms if a new antidepressant is started or when the dose is changed.

Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Silenor

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of labeling:

  • Abnormal thinking and behavioral changes
  • Suicide risk and worsening of depression .
  • CNS Depressant effects .

Clinical Trials Experience

The pre-marketing development program for Silenor included doxepin HCl exposures in 1017 subjects (580 insomnia patients and 437 healthy subjects) from 12 studies conducted in the United States. 863 of these subjects (580 insomnia patients and 283 healthy subjects) participated in six randomized, placebo-controlled efficacy studies with Silenor (doxepin tablets) doses of 1 mg, 3 mg, and 6 mg for up to 3-months in duration.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. However, data from the Silenor (doxepin tablets) studies provide the physician with a basis for estimating the relative contributions of drug and non-drug factors to adverse reaction incidence rates in the populations studied.

Associated with Discontinuation of Treatment

The percentage of subjects discontinuing Phase 1, 2, and 3 trials for an adverse reaction was 0.6% in the placebo group compared to 0.4%, 1.0%, and 0.7% in the Silenor (doxepin tablets) 1 mg, 3 mg, and 6 mg groups, respectively. No reaction that resulted in discontinuation occurred at a rate greater than 0.5%.

Adverse Reactions Observed at an Incidence of ≥ 2% in Controlled Trials

Table 1 shows the incidence of treatment-emergent adverse reactions from three long-term (28 to 85 days) placebo-controlled studies of Silenor (doxepin tablets) in adult (N=221) and elderly (N=494) subjects with chronic insomnia.

Reactions reported by Investigators were classified using a modified MedDRA dictionary of preferred terms for purposes of establishing incidence. The table includes only reactions that occurred in 2% or more of subjects who received Silenor (doxepin tablets) 3 mg or 6 mg in which the incidence in subjects treated with Silenor (doxepin tablets) was greater than the incidence in placebo-treated subjects.

Table 1: Incidence (%) of Treatment-Emergent Adverse Reactions in Long-term Placebo-Controlled Clinical Trials

System Organ Class Preferred Term* Placebo (N=278) Silenor 3 mg (N=157) Silenor 6 mg (N=203)
Nervous System Disorders
Somnolence/Sedation 4 6 9
Infections and Infestations
Upper Respiratory Tract Infection/nasopharyngitis 2 4 2
Gastroenteritis 0 2 0
Gastrointestinal Disorders
Nausea 1 2 2
Vascular Disorders
Hypertension 0 3 < 1
* Includes reactions that occurred at a rate of ≥ 2% in any Silenor-treated group and at a higher rate than placebo.

The most common treatment-emergent adverse reaction in the placebo and each of the Silenor (doxepin tablets) dose groups was somnolence/sedation.

Studies Pertinent to Safety Concerns for Sleep-promoting Drugs

Residual Pharmacological Effect in Insomnia Trials

Five randomized, placebo-controlled studies in adults and the elderly assessed next-day psychomotor function within 1 hour of awakening utilizing the digit-symbol substitution test (DSST), symbol copying test (SCT), and visual analog scale (VAS) for sleepiness, following night time administration of Silenor (doxepin tablets) .

In a one-night, double-blind study conducted in 565 healthy adult subjects experiencing transient insomnia, Silenor (doxepin tablets) 6 mg showed modest negative changes in SCT and VAS.

In a 35-day, double-blind, placebo-controlled, parallel group study of Silenor (doxepin tablets) 3 and 6 mg in 221 adults with chronic insomnia, small decreases in the DSST and SCT occurred in the 6 mg group.

In a 3-month, double-blind, placebo-controlled, parallel group study in 240 elderly subjects with chronic insomnia, Silenor (doxepin tablets) 1 mg and 3 mg was comparable to placebo on DSST, SCT, and VAS.

Other Reactions Observed During the Pre-marketing Evaluation of Silenor (doxepin tablets)

Silenor (doxepin tablets) was administered to 1017 subjects in clinical trials in the United States. Treatment-emergent adverse reactions recorded by clinical investigators were standardized using a modified MedDRA dictionary of preferred terms. The following is a list of MedDRA terms that reflect treatment-emergent adverse reactions reported by subjects treated with Silenor (doxepin tablets) .

Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse reactions are those that occurred on one or more occasions in at least 1/100 subjects; Infrequent adverse reactions are those that occurred in fewer than 1/100 subjects and more than 1/1000 subjects. Rare adverse reactions are those that occurred in fewer than 1/1000 subjects. Adverse reactions that are listed in Table 1 are not included in the following listing of frequent, infrequent, and rare AEs.

Blood and Lymphatic System Disorders: Infrequent: anemia; Rare: thrombocythemia.

Cardiac Disorders: Rare: atrioventricular block, palpitations, tachycardia, ventricular extrasystoles.

Ear and Labyrinth Disorders: Rare: ear pain, hypoacusis, motion sickness, tinnitus, tympanic membrane perforation.

Eye Disorders: Infrequent: eye redness, vision blurred; Rare: blepharospasm, diplopia, eye pain, lacrimation decreased.

Gastrointestinal Disorders: Infrequent: abdominal pain, dry mouth, gastroesophageal reflux disease, vomiting; Rare: dyspepsia, constipation, gingival recession, haematochezia, lip blister.

General Disorders and Administration Site Conditions: Infrequent: asthenia, chest pain, fatigue; Rare: chills, gait abnormal, edema peripheral.

Hepatobiliary Disorders: Rare: hyperbilirubinemia.

Immune System Disorders: Rare: hypersensitivity.

Infections and Infestations: Infrequent: bronchitis, fungal infection, laryngitis, sinusitis, tooth infection, urinary tract infection, viral infection; Rare: cellulitis staphylococcal, eye infection, folliculitis, gastroenteritis viral, herpes zoster, infective tenosynovitis, influenza, lower respiratory tract infection, onychomycosis, pharyngitis, pneumonia.

Injury, Poisoning and Procedural Complications: Infrequent: back injury, fall, joint sprain; Rare: bone fracture, skin laceration.

Investigations: Infrequent: blood glucose increased; Rare: alanine aminotransferase increased, blood pressure decreased, blood pressure increased, electrocardiogram ST-T segment abnormal, electrocardiogram QRS complex abnormal, heart rate decreased, neutrophil count decreased, QRS axis abnormal, transaminases increased.

Metabolism and Nutrition Disorders: Infrequent: anorexia, decreased appetite, hyperkalemia, hypermagnesemia, increased appetite; Rare: hypokalemia.

Musculoskeletal and Connective Tissue Disorders: Infrequent: arthralgia, back pain, myalgia, neck pain, pain in extremity; Rare: joint range of motion decreased, muscle cramp, sensation of heaviness.

Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps): Rare: lung adenocarcinoma stage I, malignant melanoma.

Nervous System Disorders: Frequent: dizziness; Infrequent: dysgeusia, lethargy, parasthesia, syncope; Rare: ageusia, ataxia, cerebrovascular accident, disturbance in attention, migraine, sleep paralysis, syncope vasovagal, tremor.

Psychiatric Disorders: Infrequent: abnormal dreams, adjustment disorder, anxiety, depression; Rare: confusional state, elevated mood, insomnia, libido decreased, nightmare.

Reproductive System and Breast Disorders: Rare: breast cyst, dysmenorrhea.

Renal and Urinary Disorders: Rare: dysuria, enuresis, hemoglobinuria, nocturia.

Respiratory, Thoracic and Mediastinal Disorders: Infrequent: nasal congestion, pharyngolaryngeal pain, sinus congestion, wheezing; Rare: cough, crackles lung, nasopharyngeal disorder, rhinorrhea, dyspnea.

Skin and Subcutaneous Tissue Disorders: Infrequent: skin irritation; Rare: cold sweat, dermatitis, erythema, hyperhidrosis, pruritis, rash, rosacea.

Surgical and Medical Procedures: Rare: arthrodesis.

Vascular Disorders: Infrequent: pallor; Rare: blood pressure inadequately controlled, hematoma, hot flush.

In addition, the reactions below have been reported for other tricyclics and may be idiosyncratic (not related to dose).

Allergic: photosensitization, skin rash.

Hematologic: agranulocytosis, eosinophilia, leukopenia, purpura, thrombocytopenia.

Read the entire FDA prescribing information for Silenor (Doxepin Tablets)

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