Doxepin is not a narcotic, but it is highly toxic in cases of overdose. You cannot purchase this medicine without a prescription. Doxepin hydrochloride is a psychotherapeutic drug, specifically a tricyclic antidepressant (TCA), used to treat psychiatric disorders including:
- Depression and/or anxiety in psychoneurotic patients.
- Depression and/or anxiety in alcoholic patients (should not be taken with alcohol).
- Depression and/or anxiety secondary to an organic disease.
- Psychotic depressive disorders with anxiety (involutional depression and manic-depressive disorders).
It is available under the brand names Sinequan, Silenor, and various others. This drug may be prescribed to you for other reasons. Silenor, a low dose version, is approved in 2010 for treating a type of insomnia characterized by difficulty of staying asleep. A cream preparation is also available for short-term treatment of atopic dermatitis and lichen simplex chronicus. Both oral and topical doxepin may cause drowsiness or sedation because of its antihistaminic effect, but adverse effects are minimal in cream preparation compared with oral capsules. Doxepin capsules for oral administration comes in 10mg, 25mg, 50mg, 75mg, and 100mg doses. It contains inactive ingredients such as magnesium stearate, colloidal silicon dioxide, microcrystalline cellulose, pre-gelatinized starch from corn, and sodium lauryl sulfate.
Prior to treatment you should tell your doctor if:
- You are allergic to doxepin capsules, cream, and other components of the medication.
- You have known hypersensitivity to similar drugs, food, and other substances. Discuss the signs and symptoms you have experienced following an allergic reaction: rash, hives, itching, shortness of breath, wheezing, cough, and swelling of the face, lips, tongue, or throat.
- You have other medical conditions such as difficulty urinating, glaucoma, sleep apnea, diabetes, and bipolar disorder.
- You have taken other drugs for depression, particularly MAO inhibitor drugs, like Isocarboxazid (Marplan), Selegiline (Emsam), Phenelzine (Nardil), Tranylcypromine (Parnate), in the past 14 days.
There are other drugs and substances that may interact with Doxepin. Tell your doctor or pharmacist about all prescription and OTC drugs you are currently taking, including herbal or natural supplements and vitamin products. Check with your doctor if it is safe to take Doxepin with your existing health conditions and all the medications you are taking.
Tricyclic antidepressants are implicated in high incidence of suicidal overdose. In a 5-year study from 2000 to 2004, over 250,000 cases involved antidepressants. Since suicide is common among patients with major depression and other mood disorders, patients must be strictly monitored for suicidal tendencies. Doxepin overdose can be fatal. Seek medical help immediately if you have taken more than the required dose and if you experience side effects associated with overdosage.
Signs and symptoms of Doxepin overdose
- Blurred vision
- Mouth dryness
- Respiratory depression
- Cardiac arrhythmia
- Urinary retention
- Paralytic ileus
- Hypothermia or hyperthermia
- Hyperactive reflexes
Black box warning
All antidepressants, including Doxepin for systemic use, has a boxed warning in their labeling due to increased risk of suicidal thinking and behavior in patients treated with antidepressants. Compared to placebo, the risk is higher in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders. Risk of suicidality has not been demonstrated in adults beyond age 24. There was a reduced risk in adult patients aged 65 and older. Out of several commercially available TCAs, only two are approved for pediatric use: clomipramine and imipramine. Imipramine is used to treat childhood enuresis (involuntary urination or bedwetting) in children ages 6 to 17 years old, while clomipramine is indicated for the treatment of major depressive disorder in pediatric patients, ages 10 to 17 years.
A comparative study in 2010 supports the decision of FDA to include a black box warning to all antidepressants. More than 20,000 pediatric patients with depression, between the ages 10 to 18 years, were observed for over 9 years. At the first year, the researchers identified 3 completed suicides and 266 attempted suicides. Furthermore, there were no relevant differences between SSRI (selective serotonin reuptake inhibitors) antidepressant drugs. Tricyclic antidepressants and SSRI agents showed similar risks.
Family members and healthcare providers must be watchful of any new or worsening psychiatric symptoms in patients being treated with doxepin. If you are taking this drug, report any symptoms to your doctor, such as mood or behavior changes, sleep problems, feelings of impulsiveness, irritability, hostility, agitation, restlessness, panic attacks, anxiety, hyperactivity, severe depression, and suicidal thoughts.