• Efficacy in Adults
• Efficacy in the Elderly
• Safety and Tolerability Profile
• Clinical Trials
• Dosing Recommendations

Efficacy demonstrated in the elderly (≥65 years) with chronic insomnia

Silenor is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.¹

Improvement in sleep maintenance was demonstrated by reductions in objective wake after sleep onset (WASO)²:

• Significant decreases in objective WASO were observed at treatment night 1, and were maintained at treatment night 85²

Objective WASO following treatment with Silenor 3 mg
in elderly patients with chronic insomnia²

Study Design: Data from a double-blind, randomized, placebo-controlled, multicenter, parallel-group study of Silenor 3 mg administered to elderly patients (aged ≥65 years) with sleep maintenance difficulties. Patients were enrolled from 31 centers in the United States between September 2005 and September 2006, and received study medication for 85 nights. Objective WASO was the primary efficacy endpoint.²

• Statistically significant improvements in subjective WASO were observed with Silenor 3 mg at nights 29 and 85, only²

In this 3-month study of elderly patients with chronic sleep maintenance insomnia, next-day residual effects were evaluated

In this study, Silenor 1 mg and 3 mg were comparable to placebo on DSST, SCT, and VAS.^1,2

Effect of Silenor 3mg on psychomotor function in
elderly patients with chronic insomnia^2,a

Note: Plotting of VAS scores is inverted for consistency with DSST and SCT scores.

^a Standard measures of next day residual effects, including the DSST, SCT, and VAS for sleepiness scores. These assessments were conducted in the evening (predose) and in the morning approximately 1 hour after the end of each nightly PSG recording.²

Data from a phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter, 3-month study to assess the efficacy and safety of Silenor 3 mg administered to elderly patients (>65 years) with primary insomnia and sleep maintenance difficulties. Eighty-one patients received placebo, and 82 received Silenor 3 mg.^1,2

Improvement in subjective total sleep time (sTST) was observed in a study of elderly patients with chronic sleep maintenance insomnia²

• Significant increases in sTST were observed with Silenor 6 mg at each week compared to placebo at each week²
• On subjective WASO, Silenor was superior to placebo at each week²

Subjective TST following treatment with Silenor 6 mg
in elderly patients with chronic insomnia²

Data from a double-blind, randomized, placebo-controlled, multicenter, parallel-group study of Silenor 6 mg administered to elderly patients (aged ≥ 65 years with sleep maintenance difficulties). Patients were enrolled from 32 centers in the United States between January and September of 2006 and received study medication for 28 nights. Subjective total sleep time was the primary efficacy endpoint.²

Next day residual effects were not evaluated in this study.

Silenor is approved for use at 3 mg and 6 mg. Do not substitute: There is no generic Silenor.

Next: Safety and tolerability

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 can not 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 complete Prescribing Information before prescribing Silenor.