Trazodone oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of trazodone hydrochloride.
Drugs List
Therapeutic Indications
Uses
Anxiety state
Depressive illness
Depressive illness with anxiety
Dosage
Manufacturer advises that trazodone therapy is continued for several months after remission, cessation should be gradual.
Adults
Depression and depression accompanied by anxiety.
Initial dose of 150mg daily in a single dose before retiring or as divided doses after food.
Increasing to 300mg daily in single or divided doses. The dose will be increased every 3 to 4 days by 50mg a day until an optimal therapeutic effect is achieved. If taken as divided doses, the largest dose should be administered on retiring. In hospitalised patients the dose may be further increased to 600mg daily in divided doses.
Once the effective dose is achieved, clinical response is usually evident within two or four weeks. The dosage may be increased to the maximum recommended in the case of non-responders. If, following this, there is no response after two to four weeks, therapy should be discontinued.
Patients should be maintained on the lowest effective dose and be periodically reassessed to determine the continued need for maintenance treatment. In general, it is preferable to continue therapy with an antidepressant until the patient has been symptomless for four to six months.
Anxiety
75mg daily increased to up to 300mg daily as necessary.
Elderly
Depression and depression accompanied by anxiety
The initial dose in very elderly or frail patients is reduced to 100mg daily as a single dose on retiring or in divided doses.
This may be increased, under supervision, according to efficacy and tolerability. The maximum daily dose should be 300mg. Single doses above 100mg should be avoided in these patients.
Patients with Renal Impairment
The Renal Drug Handbook suggests that patients with a glomerular filtration rate less than 20ml/minute should be started with small doses and increased gradually.
Contraindications
Acute alcohol intoxication
Children under 18 years
Drug intoxication
Within 2 weeks of discontinuing MAOIs
Long QT syndrome
Myocardial infarction
Torsade de pointes
Precautions and Warnings
Elderly
Family history of long QT syndrome
Suicidal ideation
Acute narrow angle glaucoma
Benign prostatic hyperplasia
Bipolar disorder
Breastfeeding
Cardiac arrhythmias
Cardiovascular disorder
Chronic constipation
Diabetes mellitus
Electrolyte imbalance
Epileptic disorder
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of torsade de pointes
Hyperthyroidism
Lactose intolerance
Phaeochromocytoma
Pregnancy
Psychosis
Raised intra-ocular pressure
Severe renal impairment
Urinary incontinence
Urinary retention
Correct electrolyte disorders before treatment
Patients at risk of suicide should be closely supervised
Psychotic disorders: may exacerbate psychotic symptoms including paranoia
Advise ability to drive/operate machinery may be affected by side effects
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Advise patient to take with or after food
Consider monitoring ECG in patients at risk of QT prolongation
If hepatic impairment symptoms occur monitor LFT & consider discontinuation
Monitor hepatic function frequently in patients with hepatic impairment
Monitor patients for signs and symptoms of Neuroleptic Malignant Syndrome
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor patients with a history of depression and/or suicide attempts
Monitor patients with cardiovascular disease
Monitor renal function in patients with renal impairment
Monitor serum electrolytes
Perform blood counts if unexplained infection or fever develops
Advise patient to seek medical advice if influenza-like symptoms develop
Advise patient/carer to contact GP immediately if signs of liver disorder
Advise patients/carers to seek medical advice if suicidal intent develops
Discontinue if jaundice or other clinical symptoms of hepatic injury
Elderly: may be more susceptible to antimuscarinic side effects
May cause postural hypotension especially in elderly
Do not withdraw this drug suddenly
Discontinue if patient enters a manic phase
Discontinue immediately if priapism occurs
Adjust dose gradually in epilepsy
Limit prescribing quantity due to suicide risk
Not licensed for all indications in all age groups
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)
Suicide related events
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, adolescents and young adults (under 25 years), antidepressants may increase the risk of suicidal thoughts and self harm.
Psychiatric conditions for which trazodone is prescribed can be associated with an increased risk of suicide related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
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
Pregnancy
Use trazodone with caution during pregnancy.
The manufacturer recommends that is preferable to avoid the use of trazodone as a precautionary measure.
The manufacturer indicates no adverse effects of trazodone on pregnancy or on the health of the foetus have been reported but as data is limited the safety is unknown. Animal studies do not indicate direct or indirect harmful effects on pregnancy or foetal development. Based on this some manufacturers advise avoiding trazodone during the 1st trimester.
Newborns should be monitored for the occurrence of withdrawal symptoms when trazodone is used until delivery.
The decision to continue medication should also consider maternal mental health. An untreated psychiatric illness can have a significant impact on maternal and foetus health. In some cases the risk of relapse if treatment is discontinued or changed may outweigh the potential risk of exposure to the foetus.
Lactation
Use trazodone with caution during breastfeeding.
There is limited data on the use of trazodone in breastfeeding. The manufacturer indicates there is a low excretion into human breast milk, but the levels of metabolites are not known. LactMed (2018) states that the excreted levels would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months or when doses of 100mg or less are used at bedtime for sleep.
The choice to discontinue breastfeeding or therapy should take into account benefit of breastfeeding to the infant and the benefit of therapy to the mother. An untreated psychiatric illness may disrupt the early mother-baby relationship.
Side Effects
Aggressive reaction
Agitation
Agranulocytosis
Allergic reaction
Anaemia
Anorexia
Anxiety
Aphasia
Arrhythmias
Arthralgia
Asthenia
Back pain
Blood dyscrasias
Blurred vision
Bowel perforation
Bradycardia
Cardiac arrhythmias
Changes in hepatic function
Chest pain
Confusion
Constipation
Convulsions
Delirium
Delusions
Diarrhoea
Disorientation
Dizziness
Drowsiness
Dry mouth
Dyspepsia
Dyspnoea
Dystonia
ECG changes
Elevation of liver enzymes
Eosinophilia
Fatigue
Fever
Flatulence
Gastro-enteritis
Gastrointestinal spasm
Hallucinations
Headache
Hepatocellular damage
Hot flushes
Hyperhidrosis
Hypersalivation
Hypertension
Hyponatraemia
Inappropriate secretion of antidiuretic hormone
Increased appetite
Influenza-like symptoms
Insomnia
Intrahepatic cholestasis
Jaundice
Leucopenia
Limb pain
Mania
Memory disturbances
Micturition disorders
Myalgia
Myoclonus
Nasal congestion
Nausea
Nervousness
Neuroleptic malignant syndrome
Nightmares
Ocular pruritus
Oedema
Palpitations
Paraesthesia
Paralytic ileus
Perspiration
Postural hypotension
Premature ventricular contractions
Priapism
Prolongation of QT interval
Pruritus
Rash
Reduced alertness
Reduced libido
Restlessness
Serotonin syndrome
Stomach pain
Suicidal tendencies
Syncope
Tachycardia
Taste disturbances
Thrombocytopenia
Tinnitus
Torsades de pointes
Tremor
Urinary hesitancy
Ventricular couplets
Ventricular tachycardia
Vertigo
Vomiting
Weakness
Weight loss
Overdosage
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 ).
Further Information
Last Full Review Date: May 2020.
Reference Sources
Summary of Product Characteristics: Molipaxin 50mg capsules. Zentiva. Revised April 2015.
Summary of Product Characteristics: Molipaxin 100mg capsules. Zentiva. Revised April 2015.
Summary of Product Characteristics: Molipaxin 150mg tablets. Zentiva. Revised April 2015.
Summary of Product Characteristics: Trazodone hydrochloride 100mg/5ml Oral solution. Creo Pharma Ltd. Revised December 2017.
Summary of Product Characteristics: Trazodone 50mg/5ml oral solution. Concordia international (formerly Focus Pharmaceuticals UK Ltd. Revised August 2017.
Summary of Product Characteristics: Trazodone 100mg capsules. Concordia international (formerly Focus Pharmaceuticals UK Ltd. Revised May 2017.
Summary of Product Characteristics: Trazodone 50mg capsules. Concordia international (formerly Focus Pharmaceuticals UK Ltd. Revised May 2017.
Summary of Product Characteristics: Trazodone 150mg capsules. Concordia international (formerly Focus Pharmaceuticals UK Ltd. Revised May 2017.
Summary of Product Characteristics: Trazodone hydrochloride 50mg/5ml oral solution. Zentiva. Revised April 2018.
Summary of Product Characteristics: Trazodone hydrochloride 50mg capsules. Zentiva. Revised April 2018.
Summary of Product Characteristics: Trazodone hydrochloride 100mg capsules. Zentiva. Revised April 2018.
Summary of Product Characteristics: Trazodone hydrochloride 150mg tablets. Zentiva. Revised April 2018.
Summary of Product Characteristics: Trazodone hydrochloride 50mg tablets. Accord Healthcare Limited. Revised May 2018.
Summary of Product Characteristics: Trazodone hydrochloride 100mg tablets. Accord Healthcare Limited. Revised May 2018.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
MHRA Drug Safety Update April 2008
Available at: https://www.mhra.gov.uk
Last accessed: 16 April 2018
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/?report=classic
Trazodone Last revised: 31st October 2018
Last accessed: 29th April 2020.
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.