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Doxepin – Usages, Side effects, Risk factors, Precautions
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About Doxepin
Doxepin is an antidepressant TCAs.
Brand name
Doxepin is available with the following brand name.
● Silenor
Doxepin – Usages, Side effects, Risk factors, Precautions
Forms of Doxepin
Doxepin is available in the following form
- Tablets
- Capsule
- Oral suspension
Tablets (Selinor)
Selinor tablets are available in the following doses
- 3 mg
- 6 mg
Capsule
Doxepin capsule is available in the following dose
- 10 mg
- 25 mg
- 50 mg
- 75 mg
- 100 mg
- 150 mg
Oral suspension
The Oral suspension of Doxepin is available in
- 10mg/mL
Disorder to treat
It is used for the treatment of the following disorder
● Insomnia
Doxepin is initiated at a low dose of 25 mg per day and gradually titrated upward every 5-7 days.
Dosage range: Orally 25-300 mg per day up to 150 mg per day as a single dose.
If the dose exceeds 150 mg per day then divide it into every 12hr.
Dosing considerations
Doxepin may be given at bedtime to decrease daytime sedation.
Insomnia (Silenor)
● For Sleep maintenance 3-6 mg Silenor was orally given within 30 minutes before bedtime.
● It should not exceed 6 mg per day.
● For Hepatic impairment/debilitated patients 3 mg orally given within 30
● minutes before bedtime.
Dosing considerations
To minimize the potential for next-day drowsiness, do not take within 3 hr of a meal (AUC increased by 41% and Cmax by 15% when taken with a high-fat meal)
Side effects
There are the following side effects of doxepin
● Sedation, fatigue, weakness, lethargy
● Headache
● Constipation
● Nausea, vomiting
● Dry mouth
● Anxiety
● Leukopenia
● Blurred vision
● Confusion, extrapyramidal symptoms (EPS), dizziness, paresthesia
● Eosinophilia
● Seizure
● Thrombocytopenia
● SIADH
● Tinnitus
● Agranulocytosis
● Increased LFTs
● Rash
● Sweating
● Orthostatic hypotension, ECG changes, tachycardia
● Agitation
● Insomnia
Warnings
In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses.
This increase was not seen in patients >24 years; a slight decrease in suicidal thinking was seen in adults >65 years.
In children and young adults, risks must be weighed against the benefits of taking antidepressants.
Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during the initial 1-2 months of therapy and dosage adjustments.
The patient’s family should communicate any abrupt changes in behavior to the healthcare provider.
Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy.
This drug is not approved for use in pediatric patients.
Pregnancy
There is no increased risk of major birth defects or miscarriage due to doxepin intake during pregnancy. There are risks of poor neonatal adaptation with exposure to drugs during pregnancy.
Neonatal adverse effects
Neonates exposed to TCAs, including doxepin, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding; such complications can arise immediately upon delivery.
Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either direct toxic effects of TCAs or possibly a drug discontinuation syndrome.
Monitor neonates who were exposed to drugs in the third trimester of pregnancy for poor neonatal adaptation syndrome
Lactation
According to studies, the presence of drugs and metabolites in human milk; there are reports of excess sedation, respiratory depression, poor sucking and swallowing, and hypotonia in breastfed infants exposed to drugs.
There is no data on the effects of drugs on milk production; because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during therapy.
Infants exposed to drugs through breast milk should be monitored for excess sedation, respiratory depression, and hypotonia.
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