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NITRAZEPAM is a brand name for Nitrazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults: Short term treatment of insomnia only when it is severe, disabling, or subjecting the individual to extreme distress. An underlying cause for insomnia should be sought before deciding on the use of benzodiazepines for symptomatic relief. Children: Not recommended.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Treatment should be given for the shortest possible duration.
Adults:
The dosage may vary according to the patient's response and the severity of the insomnia. The recommended dose is 5 mg before retiring. This, however, may be increased to 10 mg. The lowest dose which can control symptoms should be used.
It should not be continued beyond 4 weeks. Long term chronic use is not recommended. Treatment should always be tapered off gradually. Patients who have taken benzodiazepines for a long time may require a longer period during which the doses are reduced.
Elderly:
Half the normal adult dose may be sufficient for a therapeutic response in the elderly. (See Warnings and Adverse Effects).
Children:
Not recommended Route of Administration: Oral
Not for use in phobic or obsessional states because there is inadequate evidence of efficacy and safety. Should not be used alone to treat depression or anxiety associated with depression. (Suicide may be precipitated in such patients).
Not to be used for treatment of chronic psychosis. Amnesia may occur. In cases of loss or bereavement psychological adjustment may be inhibited by benzodiazepines. Not to be used for the treatment of chronic psychosis. Disinhibiting effects may be manifested in various ways.
Suicide may be precipitated in patients who are depressed and aggressive behaviour toward self and others may be precipitated. Extreme caution should therefore be used in prescribing benzodiazepines in patients with personality disorders.
4 Special warnings and precautions). Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.
These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.
Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. Withdrawal from benzodiazepines may be associated with physiological and psychological symptoms of withdrawal including depression.
Chronic pulmonary insufficiency. In chronic renal or hepatic disease. In labour. High single doses or repeated low doses have been reported to produce hypotonia, poor suckling and hypothermia in the neonate and irregularities in the foetal heart.
The use of benzodiazepines may lead to development of physical and psychological dependency upon these agents. The risk of dependence is greater the higher the dose and the longer the duration of treatment and in patients with a history of alcoholism or drug abuse.
In such cases, benzodiazepines should be used with extreme caution, the patient should be regularly monitored, routine repeat prescriptions avoided and treatment should be withdrawn gradually. Drug dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on- line, and past and present medical and psychiatric conditions.
• Known sensitivity to benzodiazepines. • Acute pulmonary insufficiency. • Respiratory depression. • Chronic psychosis. • Phobic or obsessional states. • Myasthenia gravis. • Sleep apnoea syndrome. • Severe hepatic insufficiency. • Acute porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nitrazepam in United Kingdom.
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Withdrawal symptoms occur with benzodiazepines following normal therapeutic doses for short periods of time. Dose-related adverse effects which occur commonly with nitrazepam and which may persist into the following day, even after a single dose include sedation, drowsiness, unsteadiness, and ataxia (especially in the elderly).
The elderly are particularly sensitive to the effects of centrally-depressant drugs and experience confusion, especially if organic brain changes are present. Less commonly, headache, vertigo, hypotension, gastro-intestinal disturbances, skin rashes, changes in libido and urinary retention have been reported.
Isolated cases of blood dyscrasias and jaundice have been reported. Abnormal psychological reactions have been reported and are more likely to occur in children and the elderly. Rare behavioural effects include excitement, confusion, paradoxical aggressive outbursts and unmasking of depression with suicidal tendencies.
If these occur, nitrazepam should be discontinued. Nitrazepam should not be used alone to treat depression or anxiety associated with depression, since suicide may be precipitated in such patients. Benzodiazepines may induce antegrade amnesia which occurs most often several hours after ingesting the drug.
Amnesic effects may be associated with inappropriate behaviour. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with Nitrazepam should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
Drug withdrawal syndrome Prior to starting treatment with Nitrazepam, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome. A withdrawal strategy for ending treatment with Nitrazepam should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.
Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.
If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
Depression, nervousness, irritability, rebound insomnia, sweating, panic attacks, dysphoria and diarrhoea have been reported after abrupt withdrawal of treatment even in patients who received normal therapeutic doses for a short time.
In rare cases withdrawal following excessive doses may produce convulsions, confusional states and psychotic disorders. Extreme caution should be used in prescribing benzodiazepines to patients with personality disorders. Benzodiazepines may inhibit psychological adjustment in cases of loss or bereavement.
Duration of treatment should be as short as possible. It should not exceed four weeks including the tapering off process. Treatment should not extend beyond four weeks without re-evaluation of the situation.