- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of doxepin.
Symptoms of depressive illness especially if sedation required
Optimum dosage depends on individual response and severity of condition.
Initial dosage should be 75mg daily. In more severely ill patients it may be necessary to administer a dose of up to 300mg daily in divided doses to obtain a response.
Dosage is usually within the range 25mg to 300mg daily. Doses up to 100mg may be given in once daily or in a divided schedule. If taken once per day, take at bedtime. If doses over 100mg are required they should be administered in three divided doses. Patients for whom insomnia is a troublesome symptom or if drowsiness is experienced as a side effect, dosage may be divided so that a higher proportion is administered in the evening.
It is often possible to reduce the dose for maintenance therapy once a satisfactory response has been obtained.
The optimal anti-depressant effect may not be evident for two to three weeks.
Any increase in dose should be conducted under close supervision. Half the standard maintenance dose may be sufficient to produce a satisfactory clinical response.
Children aged 12 to 18 years (unlicensed)
(See Dosage; Adult)
Children under 12 years
Within 2 weeks of discontinuing MAOIs
Long QT syndrome
Severe hepatic disorder
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Patients under 25 years
Benign prostatic hyperplasia
Cardiac conduction defects
Glucose-galactose malabsorption syndrome
History of mania
History of psychosis
History of torsade de pointes
Raised intra-ocular pressure
Recent myocardial infarction
Severe cardiac disorder
Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise patient drowsiness may affect ability to drive or operate machinery
Not all available products are licensed for all age groups
Reduce initial dose in the elderly
Some brands contain Sunset Yellow (E110) - can trigger allergic reactions
Some formulations contain amaranth (E123) - may cause allergic reactions
Some formulations contain lactose
Some formulations contain propylene glycol
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor serum electrolytes
Monitor the elderly for optimum dosing
Treatment of depression - monitor initially; may take 2-4 weeks to respond
Consider dose reduction or discontinuation if serotonin syndrome suspected
Do not withdraw this drug suddenly
Discontinue if patient enters a manic phase
Advise patient not to take St John's wort concurrently
Patient should avoid alcohol as effect may be potentiated
Advise patient/carers to report signs of suicide ideation or behaviour
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of self harm is highest shortly after presentation and the risk of suicide may increase again in the early stages of recovery. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm.
Patients with a history of suicide related events, those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, and young adults, are at a greater risk of suicidal thought or suicide attempt, and should receive careful monitoring during treatment.
Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal thoughts and behaviour, and to seek medical advice immediately if these symptoms present.
Pregnancy and Lactation
Use doxepin with caution in pregnancy.
The manufacturer advises caution if doxepin is used during pregnancy. Animal studies have shown no teratogenic effects. Doxepin is known to cross the placenta however human data is limited and as such, a potential risk cannot be ruled out.
Doxepin is contraindicated during breastfeeding.
Use of doxepin when breastfeeding is contraindicated by the manufacturer. Doxepin and it's active metabolite desmethyldoxepin are present in human breast milk at concentrations that could be as high as maternal levels (LactMed, 2022). Apnoea and drowsiness have been reported in nursing infants.
Aggravation of existing asthma
Blood sugar changes
Changes in libido
Inappropriate secretion of antidiuretic hormone
Increased risk of fractures
Prolongation of PR interval
Widened QRS complex
Withdrawal Symptoms and Signs
Withdrawal symptoms may occur within 5 days of treatment cessation. The risk of withdrawal symptoms is increased treatment is discontinued suddenly. When discontinuing doxepin, the dose should be reduced gradually over at least 4 weeks, or longer if withdrawal symptoms emerge (6 months in patients who have been on long-term maintenance treatment).
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last full review date: September 2022
Summary of Product Characteristics: Doxepin 10mg Capsules. Morningside Healthcare Ltd. Revised October 2021.
Summary of Product Characteristics: Doxepin 25mg Capsules. Dexcel Pharma Ltd. Revised March 2021.
Summary of Product Characteristics: Doxepin 50mg Capsules. Dexcel Pharma Ltd. Revised March 2021.
Summary of Product Characteristics: Doxepin 25mg Capsules. Marlborough Pharmaceuticals Ltd. Revised June 2021.
Summary of Product Characteristics: Doxepin 50mg Capsules. Marlborough Pharmaceuticals Ltd. Revised June 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 September 2022
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Doxepin. Last revised: 18 April 2022
Last accessed: 06 September 2022
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.