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warnings and cautions
5 WARNINGS AND PRECAUTIONS Need to Evaluate for comorbid 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: Doxepin tablets are 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 doxepin tablets should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., preparing and eati...
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adverse reactions
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 doxepin tablets, 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 Marlex Pharmaceuticals at 1-888-582-1953 or Drugsafety@marlexpharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The pre-marketing development program for doxepin tablets 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 doxepin 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 doxepin tablets 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 doxepin tablets 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 doxepin tablets in adult (N=221) and elderly (N=494) subjects with chronic insomnia. Reactions reported by Investigators were classified ...
adverse reactions table
Table 1 Incidence (%) of Treatment-Emergent Adverse Reactions in Long-term Placebo-Controlled Clinical TrialsSystem Organ ClassPreferred Term*Placebo(N=278)Doxepin3 mg(N=157)Doxepin6 mg(N=203)* Includes reactions that occurred at a rate of ≥ 2% in any doxepin tablets-treated group and at a higher rate than placebo.Nervous System DisordersSomnolence/Sedation469Infections and InfestationsUpper Respiratory Tract Infection/Nasopharyngitis 242Gastroenteritis020Gastrointestinal DisordersNausea122Vascular DisordersHypertension03< 1