Temazepam
Generic name
Temazepam
Brand name
ATC Code
N05CD07
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No pharmacokinetic studies have been carried out in children
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| Short-term treatment of sleep disorders |
|---|
|
Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Paradoxical reactions can occur in children in particular, with acute agitation, confusion and changes in the mental condition. The following side effects can also occur: sleepiness during the day, drowsiness, fatigue, reduced reaction and concentration capacity, ataxia, respiratory depression, physical and psychological dependency.
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in children
Severe respiratory insufficiency, sleep apnoea syndrome
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Summary:
reduces the reaction and concentration capabilities. If there are negative behavioural changes, the treatment should be discontinued. It leads to physical and psychological dependency. Be aware of the possibility of withdrawal and rebound effects too. Temazepam must not be used for longer than 4 weeks.
Using it can result in reduced capacity to react and concentrate. This can hinder numerous day-to-day activities.
Reactions such as restlessness, agitation, irritation, aggression, hallucinations, mania, nightmares, psychoses, inappropriate behaviour and other negative behavioural changes are known to occur when benzodiazepines are used. If this is the case, the treatment should be discontinued. These reactions occur in children in particular.
Using benzodiazepines and benzodiazepine-like compounds can lead to physical and psychological dependency developing. The risk of dependency is greater at high doses and in longer-term treatment. Once physical dependency has arisen, abrupt discontinuation of the treatment causes withdrawal symptoms such as (inter alia) restlessness, sleeplessness, convulsions and delirium.
The symptoms that led to the treatment with benzodiazepines (or benzodiazepine-like compounds) can return more severely after the treatment is ended. This can cause other symptoms such as mood changes, anxiety and restlessness. Because the risk of withdrawal and rebound symptoms is greater on abrupt discontinuation of the treatment, it is recommended that the dose should be cut back gradually.
The duration of the treatment must be kept as short as possible and must not exceed 4 weeks (including the period for cutting back the treatment). This period must not be extended without reassessing the patient’s condition.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
HYPNOTICS AND SEDATIVES
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| Barbiturates, plain | ||
|---|---|---|
| N05CA01 | ||
| Aldehydes and derivatives | ||
|---|---|---|
| N05CC01 | ||
| Benzodiazepine derivatives | ||
|---|---|---|
| N05CD08 | ||
| N05CD02 | ||
| Other hypnotics and sedatives | ||
|---|---|---|
| N05CM18 | ||
| N05CM21 | ||
| Melatonin receptor agonists | ||
|---|---|---|
| N05CH01 | ||
References
- Ketelaars, K, Anxiolytica/hypnotica, Landelijk Kenniscentrum Kind-enJeugdpsychiatrie, 2009, http://www.kenniscentrum-kjp.nl/index.php?id=581
- Rademaker C.M.A. et al, Geneesmiddelen formularium voor Kinderen, 2007
Changes
Therapeutic Drug Monitoring
Overdose
