Drugs Details

Drugs Info of Silenor
Drugs Details
  • Drugs Type  : Multum
  • Date : 23rd Jan 2015 05:17 am
  • Brand Name : Silenor
  • Generic Name : doxepin (Silenor) (Pronunciation: DOX e pin
Descriptions

Silenor (doxepin) is available in 3 mg and 6 mg strength tablets for oral administration. Each tablet contains 3.39 mg or 6.78 mg doxepin hydrochloride, equivalent to 3 mg and 6mg of doxepin, respectively.

Chemically, doxepin hydrochloride is an (E) and (Z) geometric, isomeric mixture of 1 propanamine, 3-dibenz[b,e]oxepin-11(6H)ylidene-N,N-dimethyl-hydrochloride. It has the following structure:

 

Silenor™
  (doxepin) Structural Formula Illustration

Doxepin hydrochloride is a white crystalline powder, with a slight amine-like odor, that is readily soluble in water. It has a molecular weight of 315.84 and molecular formula of C19H21NO•HCl.

Each Silenor (doxepin tablets) tablet includes the following 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 D&C Yellow No. 10 and FD&C Blue No. 1.

What are the possible side effects of doxepin (Silenor) (Silenor)?

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

Call your doctor at once if you have a side effect such as:

  • fast, pounding, or uneven heart rate;
  • confusion, hallucinations, unusual thoughts or behavior, seizure (convulsions);
  • new or worsening symptoms of depression (mood or behavior changes, anxiety, trouble sleeping, feeling agitated, thoughts about suicide or hurting yourself.
  • easy bruising or bleeding, unusual...

Read All Potential Side Effects and See Pictures of Silenor »

What are the precautions when taking doxepin tablets (Silenor)?

Before taking doxepin, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as amoxapine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems urinating (urinary retention), a certain eye problem (glaucoma).

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including...

Read All Potential Precautions of Silenor »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Silenor (doxepin tablets) is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. [see Clinical Studies].

Dosage Administration

The dose of Silenor (doxepin tablets) should be individualized.

Dosing in Adults

The recommended dose of Silenor (doxepin tablets) 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 (doxepin tablets) 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 (doxepin tablets) should be taken within 30 minutes of bedtime.

To minimize the potential for next day effects, Silenor (doxepin tablets) should not be taken within 3 hours of a meal [see CLINICAL PHARMACOLOGY].

The total Silenor (doxepin tablets) dose should not exceed 6 mg per day.

How Supplied

Dosage Forms And Strengths

Silenor (doxepin tablets) is an immediate-release, oval-shaped, tablet for oral administration available in strengths of 3 mg and 6 mg. The tablets are blue (3 mg) or green (6 mg) and are debossed with 3 or 6, respectively, on one side and SP on the other. Silenor (doxepin tablets) tablets are not scored.

Silenor (doxepin tablets) 3 mg tablets are oval shaped, blue, identified with debossed markings of “3” on one side and “SP” on the other, and are supplied as:

NDC 42847-103-30..................Bottle of 30
NDC 42847-103-10..................Bottle of 100
NDC 42847-103-50..................Bottle of 500
NDC 42847-103-03..................Blister trade pack of 30

Silenor (doxepin tablets) 6 mg tablets are oval shaped, green, identified with debossed markings of “6” on one side and “SP” on the other, and are supplied as:

NDC 42847-106-30..................Bottle of 30
NDC 42847-106-10..................Bottle of 100
NDC 42847-106-50..................Bottle of 500
NDC 42847-106-03..................Blister trade pack of 30

Storage and Handling

Store at controlled room temperature 20° - 25°C (68° - 77°F), protected from light.

Manufactured for: Somaxon Pharmaceuticals, Inc. San Diego, CA 92130 USA.


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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

  • Abnormal thinking and behavioral changes [see WARNINGS AND PRECAUTIONS]
  • Suicide risk and worsening of depression [see WARNINGS AND PRECAUTIONS].
  • CNS Depressant effects [see WARNINGS AND PRECAUTIONS].

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 Silenor (doxepin tablets) Side Effects Center for a complete guide to possible side effects

Interactions

Cytochrome P450 Isozymes

Silenor (doxepin tablets) is primarily metabolized by hepatic cytochrome P450 isozymes CYP2C19 and CYP2D6, and to a lesser extent, by CYP1A2 and CYP2C9. Inhibitors of these isozymes may increase the exposure of doxepin. Silenor (doxepin tablets) is not an inhibitor of any CYP isozymes at therapeutically relevant concentrations. The ability of Silenor (doxepin tablets) to induce CYP isozymes is not known.

Cimetidine

Silenor (doxepin tablets) exposure is doubled with concomitant administration of cimetidine, a nonspecific inhibitor of CYP isozymes. A maximum dose of 3 mg is recommended in adults and elderly when cimetidine is co-administered with Silenor [see CLINICAL PHARMACOLOGY]

Alcohol

When taken with Silenor (doxepin tablets) , the sedative effects of alcohol may be potentiated [see WARNINGS AND PRECAUTIONS].

CNS Depressants and Sedating Antihistamines

When taken with Silenor (doxepin tablets) , the sedative effects of sedating antihistamines and CNS depressants may be potentiated [see WARNINGS AND PRECAUTIONS].

Tolazamide

A case of severe hypoglycemia has been reported in a type II diabetic patient maintained on tolazamide (1 g/day) 11 days after the addition of oral doxepin (75 mg/day).

Drug Abuse And Dependence

Controlled Substance

Doxepin is not a controlled substance.

Abuse

Doxepin is not associated with abuse potential in animals or in humans. Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of doxepin (e.g., incrementation of dose, drug-seeking behavior).

Dependence

In a brief assessment of adverse events observed during discontinuation of doxepin following chronic administration, no symptoms indicative of a withdrawal syndrome were observed. Thus, doxepin does not appear to produce physical dependence.

Read the Silenor Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

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 (doxepin tablets) 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 ative ingredient in Silenor (doxepin tablets) , is an antidepressant at doses 10- to 100-fold higher than in Silenor (doxepin tablets) . 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 (doxepin tablets) 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 (doxepin tablets) , 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 (doxepin tablets) , and should be cautioned about potential impairment in the performance of such activities that may occur the day following ingestion.

When taken with Silenor (doxepin tablets) , the sedative effects of alcoholic beverages, sedating antihistamines, and other CNS depressants may be potentiated [see DRUG INTERACTIONS]. Patients should not consume alcohol with Silenor [see DRUG INTERACTIONS]. Patients should be cautioned about potential additive effects of Silenor (doxepin tablets) used in combination with CNS depressants or sedating antihistamines [see DRUG INTERACTIONS].

Patient Counseling Information

Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with hypnotics, should counsel them in appropriate use, and should instruct them to read the accompanying Medication Guide [see Medication Guide].

Sleep-driving and Other Complex Behaviors

There have been reports of people getting out of bed after taking a hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when a hypnotic is taken with alcohol or other central nervous system depressants [see WARNINGS AND RECAUTIONS and DRUG INTERACTIONS]. 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.

In addition, patients should be advised to report all concomitant medications to the prescriber. Patients should be instructed to report events such as “sleep-driving” and other complex behaviors immediately to the prescriber.

Suicide risk and Worsening of Depression:

Patients, their families, and their caregivers should be encouraged to be alert to worsening of depression, including suicidal thoughts and actions. Such symptoms should be reported to the patient's prescriber or health professional.

Administration Instructions

Patients should be counseled to take Silenor (doxepin tablets) within 30 minutes of bedtime and should confine their activities to those necessary to prepare for bed. Silenor (doxepin tablets) tablets should not be taken with or immediately after a meal [see DOSAGE AND ADMINISTRATION]. Advise patients NOT to take Silenor (doxepin tablets) when drinking alcohol [see WARNINGS AND RECAUTIONS and DRUG INTERACTIONS].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

No evidence of carcinogenic potential was observed when doxepin was administered orally to homozygous Tg.rasH2 mice for 26 weeks at doses of 25, 50, 75 and 100 mg/kg/day.

Mutagenesis

Doxepin was negative in in vitro (bacterial reverse mutation, chromosomal aberration in human lymphocytes) and in vivo (rat micronucleus) assays.

Impairment of Fertility

When doxepin (10, 30 and 100 mg/kg/day) was orally administered to male and female rats prior to, during and after mating, adverse effects on fertility (increased copulatory interval and decreased corpora lutea, implantation, viable embryos and litter size) and sperm parameters (increased percentages of abnormal sperm and decreased sperm motility) were observed. The plasma exposures (AUC) for doxepin and nordoxepin at the no-effect dose for adverse effects on reproductive performance and fertility in rats (10 mg/kg/day) are less than those in humans at the maximum recommended human dose of 6 mg/day.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies of Silenor (doxepin tablets) in pregnant women. Silenor (doxepin tablets) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of doxepin to pregnant animals resulted in adverse effects on offspring development at doses greater than the maximum recommended human dose (MRHD) of 6 mg/day.

When doxepin (30, 100 and 150 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, developmental toxicity (increased incidences of fetal structural abnormalities and decreased fetal body weights) was noted at ≥ 100 mg/kg/day. The plasma exposures (AUC) at the no-effect dose for embryo-fetal developmental toxicity in rats (30 mg/kg/day) are approximately 6 and 3 times the plasma AUCs for doxepin and nordoxepin (the primary metabolite in humans), respectively, at the MRHD. When administered orally to pregnant rabbits (10, 30 and 60 mg/kg/day) during the period of organogenesis, fetal body weights were reduced at the highest dose in the absence of maternal toxicity. The plasma exposures (AUC) at the no-effect dose for developmental effects (30 mg/kg/day) are approximately 6 and 18 times the plasma AUCs for doxepin and nordoxepin, respectively, at the MRHD. Oral administration of doxepin (10, 30 and 100 mg/kg/day) to rats throughout the pregnancy and lactation periods resulted in decreased pup survival and transient growth delay at the highest dose. The plasma exposures (AUC) at the no-effect dose for adverse effects on pre- and postnatal development in rats (30 mg/kg/day) are approximately 3 and 2 times the plasma AUCs for doxepin and nordoxepin, respectively, at the MRHD.

Labor and Delivery

The effects of Silenor (doxepin tablets) on labor and delivery in pregnant women are unknown.

Nursing Mothers

Doxepin is excreted in human milk after oral administration. There has been a report of apnea and drowsiness occurring in a nursing infant whose mother was taking the higher dose of doxepin used to treat depression. Caution should be exercised when Silenor (doxepin tablets) is administered to nursing women.

Pediatric Use

The safety and effectiveness of Silenor (doxepin tablets) in pediatric patients have not been evaluated.

Geriatric Use

A total of 362 subjects who were ≥ 65 years and 86 subjects who were ≥ 75 years received Silenor (doxepin tablets) in controlled clinical studies. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. Greater sensitivity of some older individuals cannot be ruled out.

Sleep-promoting drugs may cause confusion and over-sedation in the elderly. A starting dose of 3 mg is recommended in this population and evaluation prior to considering dose escalation is recommended [see DOSAGE AND ADMINISTRATION]

Use in patients with Hepatic Impairment

Patients with hepatic impairment may display higher doxepin concentrations than healthy individuals. Initiate Silenor (doxepin tablets) treatment with 3 mg in patients with hepatic impairment and monitor closely for adverse daytime effects. [see CLINICAL PHARMACOLOGY]

Use in Patients with Sleep Apnea

Silenor (doxepin tablets) has not been studied in patients with obstructive sleep apnea. Since hypnotics have the capacity to depress respiratory drive, precautions should be taken if Silenor (doxepin tablets) is prescribed to patients with compromised respiratory function. In patients with severe sleep apnea, Silenor (doxepin tablets) is ordinarily not recommended for use.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Doxepin is routinely administered for indications other than insomnia at doses 10- to 50-fold higher than the highest recommended dose of Silenor.

The signs and symptoms associated with doxepin use at doses several-fold higher than the maximum recommended dose (Excessive dose) of Silenor (doxepin tablets) for the treatment of insomnia are described, as are signs and symptoms associated with higher multiples of the maximum recommended dose (Critical overdose).

Signs and Symptoms of Excessive Doses

The following adverse effects have been associated with use of doxepin at doses higher than 6 mg.

Anticholinergic Effects: constipation and urinary retention.

Central Nervous System: disorientation, hallucinations, numbness, paresthesias, extrapyramidal symptoms, seizures, tardive dyskinesia.

Cardiovascular: hypotension.

Gastrointestinal: aphthous stomatitis, indigestion.

Endocrine: raised libido, testicular swelling, gynecomastia in males, enlargement of breasts and galactorrhea in the female, raising or lowering of blood sugar levels, and syndrome of inappropriate antidiuretic hormone secretion.

Other: tinnitus, weight gain, sweating, flushing, jaundice, alopecia, exacerbation of asthma, and hyperpyrexia (in association with chlorpromazine).

Signs and Symptoms of Critical Overdose

Manifestations of doxepin critical overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression including coma. Electrocardiogram changes, particularly in QRS axis or width, are clinically significant indicators of tricyclic compound toxicity. Other signs of overdose may include, but are not limited to: confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia.

Recommended Management

As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. In addition, the possibility of a multiple drug ingestion should be considered.

If an overdose is suspected, an ECG should be obtained and cardiac monitoring should be initiated immediately. The patient's airway should be protected, an intravenous line should be established, and gastric decontamination should be initiated. A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is strongly advised. If signs of toxicity occur at any time during this period, extended monitoring is recommended. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.

Gastrointestinal Decontamination

All patients suspected of overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by administration of activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage. Emesis is contraindicated.

Cardiovascular

A maximal limb-lead QRS duration of ≥ 0.10 seconds may be the best indication of the severity of an overdose. Serum alkalinization, using intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55 for patients with dysrhythmias and/or QRS widening. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH > 7.60 or a pCO2 < 20 mm Hg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).

In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in treatment of tricyclic compound poisoning.

Central Nervous System

In patients with central nervous system depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or, if these are ineffective, other anticonvulsants (e.g., phenobarbital or phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.

Psychiatric Follow-up

Since overdose often is deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

Pediatric Management

The principles of management of child and adult overdoses are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.

ContrainDications

Hypersensitivity

Silenor (doxepin tablets) is contraindicated in individuals who have shown hypersensitivity to doxepin HCl, any of its inactive ingredients, or other dibenoxepines.

Co-administration with Monoamine Oxidase Inhibitors (MAOIs)

Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Do not administer Silenor (doxepin tablets) if patient is currently on MAOIs or has used MAOIs within the past two weeks. The exact length of time may vary depending on the particular MAOI dosage and duration of treatment.

Glaucoma and Urinary Retention

Silenor (doxepin tablets) is contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

Doxepin binds with high affinity to the histamine H1 receptor (Ki < 1 nM) where it functions as an antagonist. The exact mechanism by which doxepin exerts its sleep maintenance effect is unknown but is believed due to its antagonism of the H1 receptor.

Pharmacodynamics

Cardiac Safety

In a thorough QTc prolongation clinical study in healthy subjects, doxepin had no effect on QT intervals or other electrocardiographic parameters after multiple daily doses up to 50 mg.

Pharmacokinetics

Absorption

The median time to peak concentrations (Tmax) of doxepin occurred at 3.5 hours postdose after oral administration of a 6 mg dose to fasted healthy subjects. Peak plasma concentrations (Cmax) of Silenor (doxepin tablets) increased in approximately a dose-proportional manner for 3 mg and 6 mg doses. The AUC was increased by 41% and Cmax by15% when 6 mg Silenor (doxepin tablets) was administered with a high fat meal. Additionally, compared to the fasted state, Tmax was delayed by approximately 3 hours. Therefore, for faster onset and to minimize the potential for next day effects, it is recommended that Silenor (doxepin tablets) not be taken within 3 hours of a meal [see DOSAGE AND ADMINISTRATION].

Distribution

Silenor (doxepin tablets) is widely distributed throughout the body tissues. The mean apparent volume of distribution following a single 6 mg oral dose of Silenor (doxepin tablets) to healthy subjects was 11,930 liters. Silenor (doxepin tablets) is approximately 80% bound to plasma proteins.

Metabolism

Following oral administration, Silenor (doxepin tablets) is extensively metabolized by oxidation and demethylation. The primary metabolite is N-desmethyldoxepin (nordoxepin).

The primary metabolite undergoes further biotransformation to glucuronide conjugates.

In vitro studies have shown that CYP2C19 and CYP2D6 are the major enzymes involved in doxepin metabolism, and that CYP1A2 and CYP2C9 are involved to a lesser extent.

Doxepin appears not to have inhibitory effects on human CYP enzymes at therapeutic concentrations. The potential of doxepin to induce metabolizing enzymes is not known. Doxepin is not a Pgp substrate.

Excretion

Doxepin is excreted in the urine mainly in the form of glucuronide conjugates.

Less than 3% of a doxepin dose is excreted in the urine as parent compound or nordoxepin. The apparent terminal half-life (t ½) of doxepin was 15.3 hours and for nordoxepin was 31 hours.

Drug Interactions

Since doxepin is metabolized by CYP2C19 and CYP2D6, inhibitors of these CYP isozymes may increase the exposure of doxepin.

Cimetidine

The effect of cimetidine, a non-specific inhibitor of CYP1A2, 2C19, 2D6, and 3A4, on Silenor (doxepin tablets) plasma concentrations was evaluated in healthy subjects. When cimetidine 300 mg BID was co-administered with a single dose of Silenor (doxepin tablets) 6 mg, there was approximately a 2fold increase in Silenor (doxepin tablets) Cmax and AUC compared to Silenor given alone. A maximum dose of doxepin in adults and elderly should be 3 mg, when doxepin is co-administered with cimetidine.

Sertraline

The effect of sertraline HCl, a selective serotonin reuptake inhibitor, on doxepin plasma concentrations was evaluated in a daytime study conducted with 24 healthy subjects. Following co-administration of doxepin 6 mg with sertraline 50 mg (at steady-state), the doxepin mean AUC and Cmax estimates were approximately 21% and 32% higher, respectively, than those obtained following administration of doxepin alone. Psychomotor function as measured by the digit symbol substitution test and symbol copy test performance was decreased more at 2-4 hours post dosing for the combination of sertraline and doxepin as compared to doxepin alone, but subjective measures of alertness were comparable for the two treatments.

Special Population:

Renal Impairment

The effects of renal impairment on doxepin pharmacokinetics have not been studied. Because only small amounts of doxepin and nordoxepin are eliminated in the urine, renal impairment would not be expected to result in significantly altered doxepin concentrations.

Hepatic Impairment

The effects of Silenor (doxepin tablets) in patients with hepatic impairment have not been studied. Because doxepin is extensively metabolized by hepatic enzymes, patients with hepatic impairment may display higher doxepin concentrations than healthy individuals.

Poor Metabolizers of CYPs

Poor metabolizers of CYP2C19 and CYP2D6 may have higher doxepin plasma levels than normal subjects.

Clinical Studies

Controlled Clinical Trials

The efficacy of Silenor (doxepin tablets) for improving sleep maintenance was supported by six randomized, double-blind studies up to 3 months in duration that included 1,423 subjects, 18 to 93 years of age, with chronic (N=858) or transient (N=565) insomnia. Silenor (doxepin tablets) was evaluated at doses of 1 mg, 3 mg, and 6 mg relative to placebo in inpatient (sleep laboratory) and outpatient settings.

The primary efficacy measures for assessment of sleep maintenance were the objective and subjective time spent awake after sleep onset (respectively, objective Wake After Sleep Onset [WASO] and subjective WASO).

Subjects in studies of chronic insomnia were required to have at least a 3-month history of insomnia.

Chronic Insomnia

Adults

A randomized, double-blind, parallel-group study was conducted in adults (N = 221) with chronic insomnia. Silenor (doxepin tablets) 3 mg and 6 mg was compared to placebo out to 30 days.

Silenor (doxepin tablets) 3 mg and 6 mg were superior to placebo on objective WASO. Silenor (doxepin tablets) 3 mg was superior to placebo on subjective WASO at night 1 only. Silenor (doxepin tablets) 6 mg was superior to placebo on subjective WASO at night 1, and nominally superior at some later time points out to Day 30.

Elderly

Elderly subjects with chronic insomnia were assessed in two parallel-group studies.

The first randomized, double-blind study assessed Silenor (doxepin tablets) 1 mg and 3 mg relative to placebo for 3 months in inpatient and outpatient settings in elderly subjects (N=240) with chronic insomnia. Silenor (doxepin tablets) 3 mg was superior to placebo on objective WASO.

The second randomized, double-blind study assessed Silenor (doxepin tablets) 6 mg relative to placebo for 4 weeks in an outpatient setting in elderly subjects (N=254) with chronic insomnia.

On subjective WASO, Silenor (doxepin tablets) 6 mg was superior to placebo.

Transient Insomnia

Healthy adult subjects (N=565) experiencing transient insomnia during the first night in a sleep laboratory were evaluated in a randomized, double-blind, parallel-group, single-dose study of Silenor (doxepin tablets) 6 mg relative to placebo. Silenor (doxepin tablets) 6 mg was superior to placebo on objective WASO and subjective WASO.

Withdrawal Effects

Potential withdrawal effects were assessed in a 35-day double blind study of adults with chronic insomnia who were randomized to placebo, Silenor (doxepin tablets) 3 mg, or Silenor (doxepin tablets) 6 mg. There was no indication of a withdrawal syndrome after discontinuation of Silenor (doxepin tablets) treatment (3 mg or 6 mg), as measured by the Tyrer's Symptom Checklist. Discontinuation-period emergent nausea and vomiting occurred in 5% of subjects treated with 6 mg Silenor (doxepin tablets) , versus 0% in 3 mg and placebo subjects.

Rebound Insomnia Effects

Rebound insomnia, defined as a worsening in WASO compared with baseline following discontinuation of treatment, was assessed in a double-blind, 35-day study in adults with chronic insomnia. Silenor (doxepin tablets) 3 mg and 6 mg showed no evidence of rebound insomnia.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Medication Guide

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

Read this Medication Guide before you start taking SILENOR (doxepin tablets) 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 (doxepin tablets) ?

After taking SILENOR (doxepin tablets) , 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 (doxepin tablets) . 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 (doxepin tablets) .

Important:

  1. Take SILENOR (doxepin tablets) exactly as prescribed
    • Do not take more SILENOR (doxepin tablets) than prescribed.
    • Take SILENOR (doxepin tablets) 30 minutes before bedtime. After taking SILENOR (doxepin tablets) , you should only do activities needed to get ready for bed.
  2. Do not take SILENOR (doxepin tablets) :
    • 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 (doxepin tablets) with your other medicines
    • if you cannot get a full night of sleep before you must be active again

What is SILENOR (doxepin tablets) ?

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

Who should not take SILENOR (doxepin tablets) ?

Do not take SILENOR (doxepin tablets) 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 (doxepin tablets) . See the end of this Medication Guide for a complete list of ingredients in SILENOR (doxepin tablets) .

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

It is not known if SILENOR (doxepin tablets) is safe and effective in children.

What should I tell my healthcare provider before taking SILENOR (doxepin tablets) ?

Before you take SILENOR (doxepin tablets) , tell your healthcare provider if you:

  • See “Who should not take Silenor (doxepin tablets) ” 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 (doxepin tablets) 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 (doxepin tablets) 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 (doxepin tablets) . You should not breast-feed while taking SILENOR (doxepin tablets) .

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

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

  • a monoamine oxidase inhibitor (MAOI). See “Who should not take SILENOR (doxepin tablets) ?”
  • 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 (doxepin tablets) ?

  • Take SILENOR (doxepin tablets) exactly as your healthcare provider tells you to take it
  • Your doctor will tell you how many SILENOR (doxepin tablets) to take and when to take them.
  • Your doctor may change your dose if needed.
  • Take SILENOR (doxepin tablets) within 30 minutes of bedtime. After taking SILENOR (doxepin tablets) , you should confine your activities to those necessary to prepare for bed.
  • Do not take SILENOR (doxepin tablets) within 3 hours of a meal. Silenor (doxepin tablets) 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 (doxepin tablets) 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 (doxepin tablets) , call your doctor or get medical help right away.

What should I avoid while taking SILENOR (doxepin tablets) ?

  • You should not drink alcohol while taking SILENOR (doxepin tablets) . Alcohol can increase your chances of getting serious side effects with SILENOR (doxepin tablets) .
  • You should not drive, operate heavy machinery, or do other dangerous activities after SILENOR (doxepin tablets) .

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

What are the possible side effects of SILENOR (doxepin tablets) ?

SILENOR (doxepin tablets) can cause serious side effects including:

  • See “What is the most important information I should know about SILENOR (doxepin tablets) ?”

The most common side effect of SILENOR (doxepin tablets) 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 (doxepin tablets) . 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 (doxepin tablets) ?

  • Store SILENOR (doxepin tablets) between 68° and 77° F (20º to 25ºC).
  • Keep SILENOR (doxepin tablets) in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.
  • Keep SILENOR (doxepin tablets) and all medicines out of the reach of children.

General Information about SILENOR (doxepin tablets)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SILENOR (doxepin tablets) for a condition for which it was not prescribed. Do not share SILENOR (doxepin tablets) 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 (doxepin tablets) . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about SILENOR (doxepin tablets) that is written for healthcare professionals.

For more information, contact Somaxon Pharmaceuticals, Inc. at 1-877-SILENOR (doxepin tablets) (745-3667) visit http://www.silenor (doxepin tablets) .com.

What are the ingredients in SILENOR?

Active Ingredient: doxepin hydrochloride

Inactive Ingredients: Microcrystalline cellulose, colloidal silicon dioxide, colloidal anhydrous silica, light anhydrous silicic acid, 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 monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DOXEPIN (SLEEP) - ORAL

 

(dox-EH-pin)

 

COMMON BRAND NAME(S): Silenor

 

USES: This medication is used to treat sleep problems (insomnia). It may help you stay asleep longer and reduce the number of times you awaken during the night. Doxepin belongs to a class of drugs known as tricyclic antidepressants. It is not known how this medication improves sleep, though it may be due to blocking histamine receptors.

 

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking doxepin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth, usually once nightly within 30 minutes before bedtime on an empty stomach, or as directed by your doctor. Do not take it within 3 hours of a meal because the effect of the medication will be delayed.

Do not take this medication unless you are able to get a full night of sleep (7-8 hours) before you must be active again.

Dosage is based on your medical condition, age, and response to therapy. Do not take more than 6 milligrams per day.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition persists or worsens after 7-10 days.

Consumer Overview Side Effect

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.

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.

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

 

Read the Silenor (doxepin tablets) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking doxepin, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as amoxapine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems urinating (urinary retention), a certain eye problem (glaucoma).

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects in a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: cimetidine.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (such as diphenhydramine), anti-seizure drugs (such as carbamazepine), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (such as codeine), psychiatric medicines (such as risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (such as allergy, cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: extreme drowsiness, hallucinations, fast/irregular heartbeat, fainting, slow/shallow breathing, seizures.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for other conditions unless directed by your doctor. A different medication may be necessary in those cases.

Usually, insomnia is temporary and requires sleep medications only for a short time. If you require treatment for more than 7-10 days, laboratory and/or medical tests should be performed to find the cause of your sleep problem.

As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Talk to your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and avoiding going to bed too early each night.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember if it is still near bedtime and you have trouble falling asleep. If it is already the next day, resume your usual dosing schedule that night at bedtime. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised September 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Silenor

Generic Name: doxepin (Silenor) (Pronunciation: DOX e pin)

  • What is doxepin (Silenor) (Silenor)?
  • What are the possible side effects of doxepin (Silenor) (Silenor)?
  • What is the most important information I should know about doxepin (Silenor) (Silenor)?
  • What should I discuss with my healthcare provider before taking doxepin (Silenor) (Silenor)?
  • How should I take doxepin (Silenor) (Silenor)?
  • What happens if I miss a dose (Silenor)?
  • What happens if I overdose (Silenor)?
  • What should I avoid while taking doxepin (Silenor) (Silenor)?
  • What other drugs will affect doxepin (Silenor) (Silenor)?
  • Where can I get more information?

What is doxepin (Silenor) (Silenor)?

Doxepin (Silenor) is in a group of drugs called hypnotics.

Doxepin (Silenor) is used to treat insomnia in people who have trouble staying asleep.

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

What are the possible side effects of doxepin (Silenor) (Silenor)?

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

Call your doctor at once if you have a side effect such as:

  • fast, pounding, or uneven heart rate;
  • confusion, hallucinations, unusual thoughts or behavior, seizure (convulsions);
  • new or worsening symptoms of depression (mood or behavior changes, anxiety, trouble sleeping, feeling agitated, thoughts about suicide or hurting yourself.
  • easy bruising or bleeding, unusual weakness;
  • feeling light-headed, fainting;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremors or uncontrollable shaking;
  • urinating less than usual or not at all; or
  • extreme thirst with headache, nausea, vomiting, and weakness.

Other common side effects may include:

  • drowsiness, dizziness;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • nausea, vomiting, diarrhea, constipation, loss of appetite;
  • dry mouth;
  • weight changes;
  • lack of coordination;
  • numbness or tingly feeling;
  • strange dreams;
  • blurred vision, headache, ringing in your ears;
  • increased sweating;
  • breast swelling (in men or women); or
  • decreased sex drive, impotence, or difficulty having an orgasm.

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.

Read the Silenor (doxepin tablets) Side Effects Center for a complete guide to possible side effects

Learn More »

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

You should not use this medication if you have untreated narrow-angle glaucoma or severe problems with urination. Do not use if you are allergic to doxepin or to similar medications such as amitriptyline, amoxapine, clomipramine, desipramine, imipramine, nortriptyline, protriptyline, or trimipramine.

Do not use doxepin if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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.

Side Effects Centers
  • Silenor

Patient Detailed How Take

What should I discuss with my healthcare provider before taking doxepin (Silenor) (Silenor)?

You should not use this medication if you have untreated narrow-angle glaucoma or severe problems with urination. Do not use if you are allergic to doxepin or to similar medications such as amitriptyline, amoxapine, clomipramine, desipramine, imipramine, nortriptyline, protriptyline, or trimipramine.

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.

Do not use doxepin if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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

  • sleep apnea (breathing stops during sleep);
  • a history of depression, mental illness, or addiction to drugs or alcohol;
  • kidney or liver disease;
  • diabetes (doxepin may raise or lower blood sugar); or
  • if you have ever had glaucoma, or urination problems.

FDA pregnancy category C. It is not known whether doxepin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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 doxepin (Silenor) (Silenor)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medication 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 tell your doctor if your symptoms do not improve after 10 days of treatment.

Store at room temperature away from moisture, heat, and light.

Side Effects Centers
  • Silenor

Patient Detailed Avoid Taking

What happens if I miss a dose (Silenor)?

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 (Silenor)?

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 (Silenor) (Silenor)?

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.

Avoid taking Silenor within 3 hours after eating a meal.

What other drugs will affect doxepin (Silenor) (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);
  • St. John's wort; or
  • tolazamide (Tolinase).

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.

Where can I get more information?

Your pharmacist can provide more information about doxepin (Silenor).


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.01. Revision date: 12/13/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Silenor

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI