Medicine guide

Silenor

3 mg · Tablet

Prescription only
Tricyclic Antidepressant

Active substance: Doxepin Hydrochloride
Used in: Pain, sleep, mood, epilepsy and the brain
Made by: Currax Pharmaceuticals LLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-04-21

What it is

Tricyclic Antidepressant

Used for

The label’s usual adult dose

Initial dose: 6 mg, once daily for adults ( 2.1 ) and 3 mg, once daily for the elderly.

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

Full directions ↓

Do not take it if

CONTRAINDICATIONS Hypersensitivity to doxepin hydrochloride, inactive ingredients, or other dibenzoxepines.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

155other products contain Doxepin Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

1.
INDICATIONS AND USAGE SILENOR 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 .
SILENOR (doxepin) tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance.
( 1 , 14 )

From the official label · 2026-04-21 · DailyMed

How it works

From this product’s own US prescribing label.

The mechanism of action of doxepin in sleep maintenance is unclear; however, doxepin's effect could be mediated through antagonism of the H 1 receptor.

Peak level after3.5 h

Half-life15.3 h

Mostly cleared after≈ 3 daysfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How the body breaks it down

Following oral administration, SILENOR is extensively metabolized by oxidation and demethylation.

How it leaves the body

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

With food

The AUC was increased by 41% and C max by 15% when 6 mg SILENOR was administered with a high fat meal.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-04-21

Do not take it if

4.
CONTRAINDICATIONS Hypersensitivity to doxepin hydrochloride, inactive ingredients, or other dibenzoxepines.
( 4.1 ) Co-administration with Monoamine Oxidase Inhibitors (MAOIs):
Do not administer if patient is taking MAOIs or has used MAOIs within the past two weeks.
( 4.2 ) Untreated narrow angle glaucoma or severe urinary retention.
( 4.3 ) 4.1.
Hypersensitivity SILENOR is contraindicated in individuals who have shown hypersensitivity to doxepin HCl, any of its inactive ingredients, or other dibenzoxepines. 4.2.
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 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. 4.3.
Glaucoma and Urinary Retention SILENOR is contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

2.
DOSAGE AND ADMINISTRATION The dose of SILENOR should be individualized.
Initial dose: 6 mg, once daily for adults ( 2.1 ) and 3 mg, once daily for the elderly.
( 2.1 , 2.2 ) Take within 30 minutes of bedtime.
Total daily dose should not exceed 6 mg.
( 2.3 ) Should not be taken within 3 hours of a meal.
( 2.3 , 12.3 ) 2.1.
Dosing in Adults The recommended dose of SILENOR for adults is 6 mg once daily.
A 3 mg once daily dose may be appropriate for some patients, if clinically indicated. 2.2.
Dosing in the Elderly The recommended starting dose of SILENOR in elderly patients (≥ 65 years old) is 3 mg once daily.
The daily dose can be increased to 6 mg, if clinically indicated. 2.3.
Administration SILENOR should be taken within 30 minutes of bedtime.
To minimize the potential for next day effects, SILENOR should not be taken within 3 hours of a meal [ see Clinical Pharmacology (12.3) ] .
The total SILENOR dose should not exceed 6 mg per day.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

5.
WARNINGS AND PRECAUTIONS Need to Evaluate for Co-morbid Diagnoses:
Reevaluate if insomnia persists after 7 to 10 days of use.
( 5.1 ) Abnormal thinking, behavioral changes, complex behaviors:
May include "Sleep-driving" and hallucinations.
Immediately evaluate any new onset behavioral changes.
( 5.2 ) Depression: Worsening of depression or suicidal thinking may occur.
Prescribe the least amount feasible to avoid intentional overdose.
( 5.3 ) CNS-depressant effects: Use can impair alertness and motor coordination.
Avoid engaging in hazardous activities such as operating a motor vehicle or heavy machinery after taking drug.
(5.4) Do not use with alcohol.
( 5.4 , 7.3 ) Potential additive effects when used in combination with CNS depressants or sedating antihistamines.
Dose reduction may be needed.
( 5.4 , 7.4 ) Patients with severe sleep apnea:
SILENOR is ordinarily not recommended for use in this population.
( 8.7 ) 5.1.
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. 5.2.
Abnormal Thinking and Behavioral Changes Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a hypnotic, with amnesia for the event) have been reported with hypnotics.
These events can occur in hypnotic-naive as well as in hypnotic-experienced persons.
Although behaviors such as "sleep-driving" may occur with hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with hypnotics appears to increase the risk of such behaviors, as does the use of hypnotics at doses exceeding the maximum recommended dose.
Due to the risk to the patient and the community, discontinuation of SILENOR should be strongly considered for patients who report a "sleep-driving" episode.
Amnesia, anxiety and other neuro-psychiatric symptoms may occur unpredictably. 5.3.
Suicide Risk and Worsening of Depression In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of hypnotics.
Doxepin, the active ingredient in SILENOR, is an antidepressant at doses 10- to 100-fold higher than in SILENOR.
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young
adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
Risk from the lower dose of doxepin in SILENOR can not be excluded.
It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder.
Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. 5.4.
CNS Depressant Effects After taking SILENOR, patients should confine their activities to those necessary to prepare for bed.
Patients should
avoid engaging in hazardous activities, such as operating a motor vehicle or heavy machinery, at night after taking SILENOR, and should be cautioned about potential impairment in the performance of such activities that may occur the day following ingestion.
When taken with SILENOR, the sedative effects of alcoholic beverages, sedating antihistamines, and other CNS depressants may be potentiated [s ee Warnings and Precautions (5.2) and Drug Interactions (7.3 , 7.4) ].
Patients should not consume alcohol with SILENOR [s ee Warnings and Precautions (5.2) and Drug Interactions (7.3) ].
Patients should be cautioned about potential additive effects of SILENOR used in combination with CNS depressants or sedating antihistamines [s ee Warnings and Precautions (5.2) and Drug Interactions (7.4) ].

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

8.1.
Pregnancy Risk Summary Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see Data ) .
There are risks of poor neonatal adaptation with exposure to tricyclic antidepressants (TCAs), including doxepin, during pregnancy (see Clinical Considerations ) .
In animal reproduction studies, oral administration of doxepin to rats and rabbits during the period of organogenesis caused adverse developmental effects at doses 65 and 23 times the maximum recommended human dose (MRHD) of 6 mg/day based on AUC, respectively.
Oral administration of doxepin to pregnant rats during pregnancy and lactation resulted in decreased pup survival and a delay in pup growth at doses 60 times the MRHD based on AUC (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal adverse reactions Neonates exposed to TCAs, including doxepin, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Such complications can arise immediately upon delivery.
Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hyperreflexia, tremor, jitteriness, irritability and constant crying.
These findings are consistent with either direct toxic effects of TCAs or possibly a drug discontinuation syndrome.
Monitor neonates who were exposed to SILENOR in the third trimester of pregnancy for poor neonatal adaptation syndrome .
Data Human Data Published epidemiologic studies of pregnant women exposed to TCAs, including doxepin, have not established an association with major birth defects, miscarriage or adverse maternal outcomes.
Methodological limitations of these observational studies include small sample size and lack of adequate controls.
Animal Data 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 consisting of non-ossified bones in the skull and sternum and decreased fetal body weights) and maternal toxicity were noted at ≥100 mg/kg/day, which produced plasma exposures (AUCs) of doxepin and nordoxepin (the primary metabolite in humans) approximately 65 and 53 times, respectively, the plasma AUCs at the MRHD.
The plasma exposures at the no-effect dose for embryo-fetal developmental toxicity in rats (30 mg/kg/day) are approximately 6 and 5 times the plasma AUCs for doxepin and nordoxepin, respectively, at the MRHD.
When doxepin (10, 30, and 60 mg/kg/day) was administered orally to pregnant rabbits during the period of organogenesis, fetal body weights were reduced at the highest dose in the absence of maternal toxicity, which produced plasma AUCs of doxepin and nordoxepin approximately 23 and 56 times, respectively, the plasma AUCs at the MRHD.
The plasma exposures at the no-effect dose for developmental effects (30 mg/kg/day) are approximately 8 and 25 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 pregnancy and lactation resulted in decreased pup survival and transient growth delay at the highest dose, which produced plasma AUCs of doxepin and nordoxepin approximately 60 and 39 times, respectively, the plasma AUCs at the MRHD.
The plasma exposures at the no-effect dose for adverse effects on pre- and postnatal development in rats (30 mg/kg/day) are approximately 2 and 1 times the plasma AUCs for doxepin and nordoxepin, respectively, at the MRHD.
8.
USE IN SPECIFIC POPULATIONS Pregnancy:
Third trimester use may increase the risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate.
( 8.1 ) Lactation: Breastfeeding not recommended.
( 8.2 ) Pediatric Use: Safety and effectiveness have not been evaluated.
( 8.4 ) Geriatric Use: The recommended starting dose is 3 mg.
Monitor prior to considering dose escalation.
( 2.2 , 8.5 ) Use in Patients with Comorbid Illness:
Initiate treatment with 3 mg in patients with hepatic impairment or tendency to urinary retention.
( 8.6 , 4.3 ) 8.1.
Pregnancy Risk Summary Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage (see Data ) .
There are risks of poor neonatal adaptation with exposure to tricyclic antidepressants (TCAs), including doxepin, during pregnancy (see Clinical Considerations ) .
In animal reproduction studies, oral administration of doxepin to rats and rabbits during the period of organogenesis caused adverse developmental effects at doses 65 and 23 times the maximum recommended human dose (MRHD) of 6 mg/day based on AUC, respectively.
Oral administration of doxepin to pregnant rats during pregnancy and lactation resulted in decreased pup survival and a delay in pup growth at doses 60 times the MRHD based on AUC (see Data ) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of major birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Clinical Considerations Fetal/Neonatal adverse reactions Neonates exposed to TCAs, including doxepin, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Such complications can arise immediately upon delivery.
Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hyperreflexia, tremor, jitteriness, irritability and constant crying.
These findings are consistent with either direct toxic effects of TCAs or possibly a drug discontinuation syndrome.
Monitor neonates who were exposed to SILENOR in the third trimester of pregnancy for poor neonatal adaptation syndrome .
Data Human Data Published epidemiologic studies of pregnant women exposed to TCAs, including doxepin, have not established an association with major birth defects, miscarriage or adverse maternal outcomes.
Methodological limitations of these observational studies include small sample size and lack of adequate controls.
Animal Data 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 consisting of non-ossified bones in the skull and sternum and decreased fetal body weights) and maternal toxicity were noted at ≥100 mg/kg/day, which produced plasma exposures (AUCs) of doxepin and nordoxepin (the primary metabolite in humans) approximately 65 and 53 times, respectively, the plasma AUCs at the MRHD.
The plasma exposures at the no-effect dose for embryo-fetal developmental toxicity in rats (30 mg/kg/day) are approximately 6 and 5 times the plasma AUCs for doxepin and nordoxepin, respectively, at the MRHD.
When doxepin (10, 30, and 60 mg/kg/day) was administered orally to pregnant rabbits during the period of organogenesis, fetal body weights were reduced at the highest dose in the absence of maternal toxicity, which produced plasma AUCs of doxepin and nordoxepin approximately 23 and 56 times, respectively, the plasma AUCs at the MRHD.
The plasma exposures at the no-effect dose for developmental effects (30 mg/kg/day) are approximately 8 and 25 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 pregnancy and lactation resulted in decreased pup survival and transient growth delay at the highest dose, which produced plasma AUCs of doxepin and nordoxepin approximately 60 and 39 times, respectively, the plasma AUCs at the MRHD.
The plasma exposures at the no-effect dose for adverse effects on pre- and postnatal development in rats (30 mg/kg/day) are approximately 2 and 1 times the plasma AUCs for doxepin and nordoxepin, respectively, at the MRHD. 8.2.
Lactation Risk Summary Data from the published literature report the presence of doxepin and nordoxepin in human milk.
There are reports of excess sedation, respiratory depression, poor sucking and swallowing, and hypotonia in breastfed infants exposed to doxepin.
There are no data on the effects of doxepin on milk production.
Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, clinicians should advise patients that breastfeeding is not recommended during treatment with SILENOR.
Clinical Considerations Infants exposed to SILENOR through breast milk should be monitored for excess sedation, respiratory depression and hypotonia. 8.3.
Females and Males of Reproductive Potential Infertility Based on results from animal fertility studies conducted in rats, doxepin may reduce fertility in females and males of reproductive potential [see Nonclinical Toxicology (13.1) ] .
It is unknown if the effects are reversible. 8.4.
Pediatric Use The safety and effectiveness of SILENOR in pediatric patients have not been evaluated . 8.5.
Geriatric Use A total of 362 subjects who were ≥ 65 years and 86 subjects who were ≥ 75 years received SILENOR 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 (2.2) ]. 8.6.
Use in Patients with Hepatic Impairment Patients with hepatic impairment may display higher doxepin concentrations than healthy individuals.
Initiate SILENOR treatment with 3 mg in patients with hepatic impairment and monitor closely for adverse daytime effects. [see Clinical Pharmacology (12.3) ] 8.7.
Use in Patients with Sleep Apnea SILENOR 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 is prescribed to patients with compromised respiratory function.
In patients with severe sleep apnea, SILENOR is ordinarily not recommended for use.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

7.
DRUG INTERACTIONS MAO inhibitors:
SILENOR should not be administered in patients on MAOIs within the past two weeks.
( 4.2 ) Cimetidine: Increases exposure to doxepin.
( 7.2 ) Alcohol: Sedative effects may be increased with doxepin.
( 7.3 , 5.4 ) CNS Depressants and Sedating Antihistamines:
Sedative effects may be increased with doxepin.
( 7.4 , 5.4 ) Tolazamide: A case of severe hypoglycemia has been reported.
( 7.5 ) 7.1.
Cytochrome P450 Isozymes SILENOR 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 is not an inhibitor of any CYP isozymes at therapeutically relevant concentrations.
The ability of SILENOR to induce CYP isozymes is not known. 7.2.
Cimetidine SILENOR 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 (12.3) ] 7.3.
Alcohol When taken with SILENOR, the sedative effects of alcohol may be potentiated [ see Warnings and Precautions (5.2 , 5.4) ] . 7.4.
CNS Depressants and Sedating Antihistamines When taken with SILENOR, the sedative effects of sedating antihistamines and CNS depressants may be potentiated [ see Warnings and Precautions (5.2 , 5.4) ] . 7.5.
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).

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

10.
OVERDOSAGE 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 for the treatment of insomnia are described [see Overdosage (10.1) ] , as are signs and symptoms associated with higher multiples of the maximum recommended dose (Critical overdose) [see Overdosage (10.2) ] . 10.1.
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). 10.2.
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.
10.3 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 pCO 2 <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.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

9.
DRUG ABUSE AND DEPENDENCE 9.1.
Controlled Substance Doxepin is not a controlled substance. 9.2.
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). 9.3.
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.
9.1. Controlled Substance Doxepin is not a controlled substance.

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

8.4. Pediatric Use The safety and effectiveness of SILENOR in pediatric patients have not been evaluated .

Quoted from the official label, section “Pediatric Use”.

Use in older people

8.5.
Geriatric Use A total of 362 subjects who were ≥ 65 years and 86 subjects who were ≥ 75 years received SILENOR 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 (2.2) ].

Quoted from the official label, section “Geriatric Use”.

Side effects

6.
ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of labeling:
Abnormal thinking and behavioral changes [see Warnings and Precautions (5.2) ].
Suicide risk and worsening of depression [see Warnings and Precautions (5.3) ].
CNS Depressant effects [see Warnings and Precautions (5.4) ].
The most common treatment-emergent adverse reactions, reported in ≥ 2% of patients treated with SILENOR, and more commonly than in patients treated with placebo, were somnolence/sedation, nausea, and upper respiratory tract infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Currax Pharmaceuticals LLC at 1-800-793-2145 and or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1.
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 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 trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
However, data from the SILENOR 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 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 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 3 mg or 6 mg in which the incidence in subjects treated with SILENOR 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 Includes reactions that occurred at a rate of ≥ 2% in any SILENOR-treated group and at a higher rate than placebo.
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 The most common treatment-emergent adverse reaction in the placebo and each of the SILENOR dose groups was somnolence/sedation. 6.2.
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.
In a one-night, double-blind study conducted in 565 healthy adult subjects experiencing transient insomnia, SILENOR 6 mg showed modest negative changes in SCT and VAS.
In a 35-day, double-blind, placebo-controlled, parallel group study of SILENOR 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 1 mg and 3 mg was comparable to placebo on DSST, SCT, and VAS. 6.3.
Other Reactions Observed During the Pre-marketing Evaluation of SILENOR SILENOR 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.
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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

17.
PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (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 Precautions (5.2 , 5.4) and Drug Interactions (7.3 , 7.4) ].
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 within 30 minutes of bedtime and should confine their activities to those necessary to prepare for bed.
SILENOR tablets should not be taken with or immediately after a meal [ see Dosage and Administration (2.3) ].
Advise patients NOT to take SILENOR when drinking alcohol [ see Warnings and Precautions (5.2 , 5.4) and Drug Interactions (7.3) ].
Pregnancy Advise patients that SILENOR use late in pregnancy may increase the risk for neonatal complications requiring prolonged hospitalization, respiratory support or tube feeding [see Use in Specific Populations (8.1) ].
Lactation Advise patients that breastfeeding is not recommended during treatment with SILENOR [see Use in Specific Populations (8.2) ].
Infertility Inform patients that SILENOR may cause reduced fertility.
It is not known whether these effects on fertility are reversible [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1) ].

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

3.
DOSAGE FORMS AND STRENGTHS SILENOR 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 tablets are not scored. 3 mg and 6 mg tablets.
Tablets not scored.
( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

16.
HOW SUPPLIED/STORAGE AND HANDLING 16.1.
How Supplied SILENOR 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 SILENOR 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 16.2.
Storage and Handling
Store at controlled room temperature 20° - 25°C (68° - 77°F), protected from light.
16.1.
How Supplied SILENOR 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 SILENOR 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

Quoted from the official label, section “How Supplied”.

How to store it

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

Quoted from the official label, section “Storage and Handling”.

What is in it

11.
DESCRIPTION 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(6 H )ylidene- N,N -dimethyl-hydrochloride.
It has the following structure:
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 C 19 H 21 NO∙HCl.
Each SILENOR 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.
Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (16)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 16 of 16

Details

Made by	Currax Pharmaceuticals LLC
Active substance	Doxepin Hydrochloride
Used in	Pain, sleep, mood, epilepsy and the brain
Strength	3 mg
Form	Tablet
Route	Oral
Packs	30 TABLET in 1 BLISTER PACK · 100 TABLET in 1 BOTTLE
NDC	42847-103

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet2 products
- 3 mg
- 6 mg

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Doxepin3 mgPrescription onlyTablet Strides Pharma Science Limited · Doxepin Hydrochloride Doxepin6 mgPrescription onlyTablet Strides Pharma Science Limited · Doxepin Hydrochloride Doxepin6 mgPrescription onlyTablet REMEDYREPACK INC. · Doxepin Hydrochloride Doxepin3 mgPrescription onlyTablet Bryant Ranch Prepack · Doxepin Hydrochloride Doxepin6 mgPrescription onlyTablet Bryant Ranch Prepack · Doxepin Hydrochloride Doxepin Hydrochloride50 mg/gPrescription onlyCream Teva Pharmaceuticals USA, Inc. · Doxepin Hydrochloride

See every product with Doxepin Hydrochloride