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The target symptoms of psychoneurosis that respond particularly well to SINEQUAN include anxiety, tension, depression, somatic symptoms and concerns, sleep disturbances, guilt, lack of energy, fear, apprehension and worry. Doxepin Sinequan Sam Martin T Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness, hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a dayto-day basis, since changes may be abrupt. Suicide: Since suicide is an inherent risk in any depressed patient and may remain so until significant improvement has occurred, patients should be closely supervised during the early course of therapy. Psychosis: Should increased symptoms of psychosis or shift to manic symptomatology occur, it may be necessary to reduce dosage or add a major tranquilizer to the dosage regimen. Geriatric Use: A determination has not been made whether controlled clinical studies of SINEQUAN included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects.

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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. Anyone considering the use of Sinequan or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

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