Indicated for the treatment of:

Psychoneurotic Patients with Depression and/or Anxiety

Depression and/or Anxiety Associated with Alcoholism (not to be taken concomitantly with alcohol)

Depression and/or Anxiety Associated with Organic Disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)

Psychotic Depressive Disorders with Associated Anxiety including Involutional Depression and Manic-Depressive Disorders

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.

It should be noted that Sinequan is not approved for use in treating bipolar depression.

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. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

Sinequan is contraindicated in patients with glaucoma or a tendency to urinary retention.

The pupillary dilation that occurs following use of many antidepressant drugs including Sinequan may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

The 150 mg capsule strength is intended for maintenance therapy only and is not recommended for initiation of treatment.

Alcohol ingestion may increase the danger inherent in any intentional or unintentional doxepin overdose. This is especially important in patients who may use alcohol excessively.

Since drowsiness may occur with the use of this drug, patients should be warned of the possibility and cautioned against driving a car or operating dangerous machinery while taking the drug. Patients should also be cautioned that their response to alcohol may be potentiated.

Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of doxepin and observed closely.

Serious side effects and even death have been reported following the concomitant use of certain drugs with MAO inhibitors. Therefore, MAO inhibitors should be discontinued at least two weeks prior to the cautious initiation of therapy with SINEQUAN. The exact length of time may vary and is dependent upon the particular MAO inhibitor being used, the length of time it has been administered, and the dosage involved.

Sufficient time must elapse before initiating tricyclic antidepressants (TCAs) in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Serious anticholinergic symptoms (i.e., severe dry mouth, urinary retention and blurred vision) have been associated with elevations in the serum levels of tricyclic antidepressant when cimetidine therapy is initiated. Additionally, higher than expected tricyclic antidepressant levels have been observed when they are begun in patients already taking cimetidine.

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. 

A case of severe hypoglycemia has been reported in a type II diabetic patient maintained on tolazamide.

Since there is no experience in pregnant women who have received this drug, safety in pregnancy has not been established.

There has been a report of apnea and drowsiness occurring in a nursing infant whose mother was taking SINEQUAN.

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• Adult dosage greater than 300 mg per day. GoToSource

• Use in patients under 18 years of age. GoToSource

• Prophylactic agent for migraines. GoToSource

• Insomnia. GoToSource

• Chronic urticaria. GoToSource

• Chronic neuropathic pain. GoToSource

• Cyclic vomiting syndrome. GoToSource

• Pruritus. GoToSource

• Smoking cessation. GoToSource

• Refractory irritable bowel syndrome. GoToSource

• Urinary urge incontinence. GoToSource 

• Opiate withdrawal syndrome. GoToSource

Suicidal ideation and behavior (suicidality). GoToSource

Sudden cardiac death and ventricular arrhythmia. GoToSource 

Withdrawal symptoms including anxiety, agitation, insomnia, mania and rebound depression. GoToSource

Liver injury, acute glaucoma, urinary retention and hypersensitivity reactions. GoToSource

Movement disorders. GoToSource

Weight gain. GoToSource

Hypomania or mania in patients with bipolar disorder. GoToSource

Sexual dysfunction. GoToSource

Lawsuits filed for suicidal behavior.