SILENOR® (doxepin) significantly increases total sleep time (TST) and reduces nighttime awakenings1

SILENOR® vs placebo, night 1 sustained through night 29

Placebo night 1

6.2

hours TST

SILENOR® 3 mg night 1

6.9

hours TST

(11.3% increase)

SILENOR® 6 mg night 1

7.0

hours TST

(12.9% increase)

SILENOR® significantly reduced duration of nighttime awakenings vs placebo*

Objective wake after sleep onset (WASO) in adults

SILENOR® provided statistically significant improvement in sleep efficiency between hours 2 and 6 vs placebo1

Sleep efficiency in adults with chronic insomnia, night 1

  • No statistically significant difference was seen in sleep efficiency on night 1 for SILENOR® 3-mg dosage at hour 7 or for SILENOR® 6-mg dosage at hour1
  • Psychomotor function tests showed no statistically significant differences between the SILENOR® and placebo groups

*Data from a double-blind, randomized, placebo-controlled, multicenter, parallel-group study of SILENOR® 3-mg dosage, SILENOR® 6-mg dosage, or placebo administered to adult patients with insomnia (N=229) aged 18 to 64 years. Patients with sleep maintenance difficulties were enrolled from 22 sleep centers in the United States. Study medication was administered for 35 nights. Objective WASO on night 1 was the primary efficacy endpoint. Sleep efficiency was a secondary endpoint.1

Ratio of time asleep vs time in bed.2

SILENOR® is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.

Important Safety Information

SILENOR® is contraindicated in individuals who have shown hypersensitivity to doxepin HCl, any of its inactive ingredients, or other dibenzoxepines. Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors (MAOIs). 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.

SILENOR® is contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention.

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.

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 or other central nervous system depressants with hypnotics appears to increase the risk of such behaviors, as does the use of hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of SILENOR® should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (i.e., 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.

Patients should not consume alcohol with SILENOR®. Patients should be cautioned about potential additive effects of SILENOR® used in combination with CNS depressants or sedating antihistamines.

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 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® cannot be excluded.

Patients should not take SILENOR® unless they are prepared to get a full night’s sleep. 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.

For faster onset and to minimize the potential for next day effects, SILENOR® should not be taken within 3 hours of a meal.

In clinical trials, the most common treatment-emergent adverse reaction was somnolence/sedation.

SILENOR® has not been studied in pregnant women. SILENOR® is excreted in human milk after oral administration. SILENOR® is not approved for use in children.

Please see full Prescribing Information before prescribing SILENOR®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References: 1. Krystal AD, Lankford A, Durrence HH, et al. Efficacy and safety of doxepin 3 and 6 mg in a 35-day sleep laboratory trial in adults with chronic primary insomnia. Sleep. 2011;34(10):1433-1442. 2. Peters B. Defining sleep efficiency: how to calculate and ways to improve it. Verywell website. https://www.verywell.com/sleep-efficiency-3014912. Updated January 29, 2017. Accessed April 26, 2018.

Important Safety Information

SILENOR® is contraindicated in individuals who have shown hypersensitivity to doxepin HCl, any of its inactive ingredients, or other dibenzoxepines. Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors (MAOIs). 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.

SILENOR® is contraindicated in individuals with untreated narrow angle glaucoma or severe urinary retention.

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.

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 or other central nervous system depressants with hypnotics appears to increase the risk of such behaviors, as does the use of hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of SILENOR® should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (i.e., 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.

Patients should not consume alcohol with SILENOR®. Patients should be cautioned about potential additive effects of SILENOR® used in combination with CNS depressants or sedating antihistamines.

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 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® cannot be excluded.

Patients should not take SILENOR® unless they are prepared to get a full night’s sleep. 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.

For faster onset and to minimize the potential for next day effects, SILENOR® should not be taken within 3 hours of a meal.

In clinical trials, the most common treatment-emergent adverse reaction was somnolence/sedation.

SILENOR® has not been studied in pregnant women. SILENOR® is excreted in human milk after oral administration. SILENOR® is not approved for use in children.

Please see full Prescribing Information before prescribing SILENOR®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.