- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of mianserin hydrochloride
Symptoms of depressive illness especially if sedation required
It is often advantageous to maintain antidepressant treatment for several months after clinical improvement is seen. To ensure optimal antidepressant effect, dosage of mianserin should not be reduced.
For adults under 65
Initially 30 to 40 mg daily, in divided doses or as a single dose at bedtime. This dose can be gradually increased as necessary. The usual daily dosage is within the range 30 to 90 mg. The manufacturer states that divided doses up to 200 mg are well tolerated.
For adults over 65
The use of mianserin is restricted to those who do not respond to other antidepressant drugs. Patients with narrow angle glaucoma or prostatic disorders should be monitored due to possible anticholinergic side effects. The manufacturer states that anticholinergic side effects are not anticipated with mianserin therapy.
The initial dose should not be more than 30 mg daily. Any further increases should be performed under close supervision.
A single night time dose should be preferable to the divided dose in older people. A lower than normal maintenance dose may be sufficient to produce a satisfactory clinical response.
Children under 18 years
Within 2 weeks of discontinuing MAOIs
Severe hepatic impairment
Precautions and Warnings
Patients over 65 years
Narrow angle glaucoma
Recent myocardial infarction
Patients at risk of suicide should be closely supervised
Advise patient drowsiness may affect ability to drive or operate machinery
Full blood count recommended every 4 weeks during first 3 months
Monitor for depressive disorders/suicidal ideation-consider discontinuation
Monitor for mental changes, suicidal depression and antisocial behaviour
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor patient initially- response may take 2 or more weeks
Advise patient to report any new or worsening depression/suicidal ideation
Advise patients/carers to seek medical advice if suicidal intent develops
Consider hyponatraemia in all patients with drowsiness/confusion/seizures
Patient should report worrying psychological changes esp. suicidal thoughts
Discontinue at first signs of jaundice
Discontinue if blood dyscrasia develops
Discontinue if convulsions occur
Discontinue if patient enters a manic phase
Advise patient concurrent alcohol will increase drowsiness
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
Mianserin is contraindicated during pregnancy.
Use of mianserin during pregnancy is contraindicated by the manufacturer.
At the time of writing, there is insufficient data available to assess the safety of mianserin in pregnant women.
Animal studies have not shown mianserin to be a hazard.
Mianserin is contraindicated during breastfeeding.
The manufacturer advises that breastfeeding should be discontinued if treatment with mianserin is considered essential.
A study on two breastfeeding women has found that mianserin can be excreted in breast milk (Schaefer 2015).
When drug treatment for depression is urgently needed, monotherapy with amitriptyline, clomipramine, nortriptyline, imipramine, desipramine or dosulepin is the treatment of choice during breastfeeding (Schaefer 2007).
Bone marrow depression
Liver function disturbances
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: November 2019
British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Summary of Product Characteristics: Mianserin tablets 10mg. Generics UK Ltd. Revised May 2017.
Summary of Product Characteristics: Mianserin tablets 30mg. Generics UK Ltd. Revised January 2014.
MHRA 4th February 2008
Last accessed: July 25, 2013
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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