Silenor

Warnings
Precautions

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.

Last reviewed on RxList: 4/2/2010
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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