SILENOR (doxepin hydrochloride)

AbsorptionThe 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 increased in approximately a dose-proportional manner for 3 mg and 6 mg doses. The AUC was increased by 41% and C max by 15% when 6 mg SILENOR was administered with a high fat meal. Additionally, compared to the fasted state, T max was delayed by approximately 3 hours. Therefore, for fa...

14.1. Controlled Clinical Trials The efficacy of SILENOR 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 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...

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 somnolen...

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 s...

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 ...

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 h...