- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Tablets containing 5mg nitrazepam
Oral suspension containing nitrazepam 2.5mg per 5ml
Short term treatment for insomnia where daytime sedation is acceptable. Only for use when insomnia is severe or disabling, or subjecting the individual to extreme distress.
The lowest dose which can control the symptoms should be used, as nitrazepam is a long acting benzodiazepine. If possible, treatment should be intermittent. The maximum dose should not be exceeded.
5mg before retiring to bed. May be increased to 10mg if necessary.
2.5mg before retiring to bed. May be increased to 5mg if necessary.
Patients with Renal Impairment
Use with caution and reduce dose
2.5mg before retiring to bed. May be increased to 5mg if necessary.
Start with small doses in patients with glomerular filtration rate <10ml/min.
Patients with Hepatic Impairment
Avoid in severe hepatic impairment.
Mild to moderate impairment: 2.5mg before retiring to bed. May be increased to 5mg if necessary.
May precipitate coma.
Additional Dosage Information
Dosage should not exceed 5mg in patients with organic brain changes.
Dosage may need to be reduced in patients with chronic pulmonary insufficiency.
Duration of treatment varies from a few days to two weeks, with a maximum of four weeks, including the tapering off process.
Patients who have taken benzodiazepines chronically may require a longer tapering off period. Extension beyond the maximum treatment period may be necessary but should not take place without re-evaluation of the patient's status.
The patient should be checked regularly at the start of treatment in order to decrease the dose or frequency of administration if necessary, in order to prevent overdose due to accumulation.
For oral administration
Children under 1 month
Acute pulmonary insufficiency
Phobic or obsessional states
Severe hepatic impairment
Marked neuromuscular weakness
Lactation (see Lactation )
Not for use to treat depression, anxiety associated with depression or chronic psychoses with benzodiazepine alone, due to precipitated risk of suicide.
Precautions and Warnings
Hepatic impairment (see Dosage - Hepatic Impairment )
Renal impairment (see Dosage - Renal Impairment )
Psychological or personality disorders
Pregnancy (see Pregnancy )
Elderly and debilitated patients are particularly susceptible to adverse effects.
Undesirable effects such as drowsiness may persist into the next day due to nitrazepam's long half life.
Sedation, amnesia, impaired concentration and impaired muscle function may occur, modifying patients' performance at skilled tasks. If affected, patients should not drive or operate machinery.
Duration of treatment should be as short as possible, depending on the indication, but should not exceed 4 weeks including any dose-tapering period for insomnia. Extension beyond this maximum time period should not take place without re-evaluation of the patient's status.
Alcohol may intensify impaired alertness, and should therefore be avoided during treatment.
Tolerance to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
The risk of development of physical and psychic dependence on benzodiazepines increases with dose and duration of treatment. The lowest possible dose necessary to control symptoms should therefore be used for the shortest period of time, ideally intermittently.
Patients with a history of alcohol or drug abuse are also at greater risk of dependence.
Dosage should be decreased gradually to avoid withdrawal symptoms. These are more likely if physical dependence has developed during usage.
Rebound insomnia and anxiety (a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form) may occur on withdrawal of treatment. The risk of this is greater after abrupt discontinuation; therefore gradual withdrawal is recommended.
Patients should be informed upon commencing treatment that it will be of limited duration, and that the dosage will be decreased progressively. Patients should also be warned of the risk of withdrawal symptoms if a change to a short-acting benzodiazepine is made.
Benzodiazepines may induce anterograde amnesia, occurring most often several hours after ingesting the product. Patients should therefore ensure they are able to devote 7-8 hours to sleep before taking nitrazepam.
Discontinue nitrazepam if psychiatric and paradoxical reactions occur. These may be severe and are more likely in children and elderly.
Psychological adjustment may be inhibited by benzodiazepines in cases of loss or bereavement.
Risk of falls and consequently hip fractures, particularly for elderly patients when they get up at night, due to myorelaxant effect.
Patients with chronic kidney disease (CKD) of stage 5 status will be more susceptible to adverse side effects.
Some formulations contain lactose and should be used with caution in patients with galactosaemia, glucose and galactose malabsorption syndrome and lactose intolerance.
Some formulations contain sucrose and should be used with caution in patients with hereditary fructose intolerance and glucose and galactose malabsorption syndrome.
Benzodiazepines are indicated for the short-term relief (two to four weeks only) of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness.
The use of benzodiazepines to treat short-term 'mild' anxiety is inappropriate and unsuitable.
Benzodiazepines should be used to treat insomnia only when it is severe, disabling, or subjecting the individual to extreme distress.
Use in Porphyria
Nitrazepam has been associated with acute attacks of porphyria and is considered unsafe in porphyric patients.
Pregnancy and Lactation
Nitrazepam is not recommended during pregnancy.
Benzodiazepines cross the placenta, and accumulation may occur in the neonate due to a low rate of metabolism. Some studies suggest a risk of malformations after exposure to benzodiazepines in the first trimester, such as cardiac malformations, facial clefts, intestinal atresia, and microcephaly. Administration during the late phase of pregnancy, or during labour at high doses, may cause 'floppy infant syndrome' (hypothermia, hypotonia, sedation, sucking problems, apnoea and cyanosis). Neonatal dependence and withdrawal symptoms which may include hypertonia, hyperreflexia, restlessness, sleeping disorders and tremors, may also occur in infants of mothers who took benzodiazepines chronically during the latter stages of pregnancy.
Data on the long-term effects of foetal exposure to benzodiazepines are scarce.
However, benzodiazepines are among the drugs of first choice for the treatment of anxiety and sleeping disorders during pregnancy (Schaefer et al, 2007). They should be given at the lowest possible dose for the shortest time, and long-acting benzodiazepines should be avoided. Observe the neonate for respiratory depression, withdrawal symptoms or adaption problems, particularly when benzodiazepines have been used up to delivery.
If prescribed to a woman of child bearing potential, she should be warned to contact her doctor if she becomes, or intends to become pregnant.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Licensed in pregnancy? - No
Recommended for use in pregnancy? - No
Crosses placenta? - Yes
Effects on foetus - Possibility of malformations, 'floppy infant syndrome', neonatal withdrawal and dependence.
Other information - Benzodiazepines are drugs of choice for anxiety and sleeping disorders, but should be used at the lowest possible dose for the shortest duration. Long acting benzodiazepines should be avoided.
Nitrazepam is not recommended during breast feeding.
Benzodiazepines are excreted in breast milk, and may result in lethargy and poor feeding. The elimination capacity for newborns develops within the first few weeks of life. The UK Drugs in Lactation Advisory Service advises that low doses (equivalent to <10mg diazepam/day) may be administered to nursing mothers, but high doses (equivalent to >10mg diazepam/day) should only be administered when the mother and infant can be monitored, as minor adverse effects have been described.
Diphenhydramine is the drug of choice for sleep disturbances during lactation, and short-acting benzodiazepines are preferred if their use is unavoidable. Single doses of benzodiazepines do not require any limitation of breastfeeding (Schaefer et al 2007). There is insufficient experience on the long-term effects on breastfed children as a result of ongoing therapy in their mothers. Long term use of benzodiazepines in nursing mothers could conceivably alter CNS function in the infant and should therefore be avoided, and the CSM has recommended that they should not be given to breastfeeding mothers.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Drug excreted in breast milk? - Yes
Considered suitable or recommended by manufacturer? - No, contraindicated.
UK Drugs in Lactation Advisory Service Classification - High doses equivalent to > 10 mg diazepam daily carry a minor level of risk of side effects. Low doses (equiv. < 10mg diazepam daily) give very low levels in infants and are considered safe. (5 mg of Nitrazepam is equiv. to 5 mg of Diazepam for example.)
Drug substance licensed in infants? - No
Effects on Ability to Drive and Operate Machinery
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.
Advise patients not to drive or operate machinery if affected by sedation, amnesia, impaired concentration or impaired muscle function.
Advise patients that impairment may be intensified by alcohol.
Advise patients of childbearing potential to contact their doctor if they intend to become or suspect they are pregnant.
Drowsiness and light-headedness (next day)
Increased hostility and aggression (paradoxical)
Changes in libido
Pre-existing depression may be unmasked
Disturbances in attention
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 ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Shelf Life and Storage
Do not store above 25C. Protect from light. Do not freeze.
Last Full Review Date: September 2012
Summary of Product Characteristics: Mogadon 5mg tablets. Meda Pharmaceuticals. Revised June 2009.
Summary of Product Characteristics: Somnite suspension. Norgine Ltd. Revised July 2010.
Summary of Product Characteristics: Nitrazepam. Actavis UK Ltd. Revised November 2012.
The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Clinical Knowledge Summaries: 'Benzodiazepine and z-drug withdrawal - Management'
Available at: https://www.cks.nhs.uk/benzodiazepine_and_z_drug_withdrawal/management/quick_answers/scenario_benzodiazepine_and_z_drug_withdrawal/switching_to_diazepam/additional_information#368592004 Last accessed: <...December 17, 2009...>
UK MiCentral: Drugs in breast milk - Quick reference guide.
Available at: https://www.ukmicentral.nhs.uk/drugpreg/qrg_p1.asp
Last accessed: <...December 17, 2009...>
Committee on Safety of Medicines/Medicines Control Agency. Current problems in Pharmacovigilance (1997); 23: 10
Available at: https://www.mhra.gov.uk/Publications/CON007479
Reminder: avoid benzodiazepines in pregnancy and lactation .
Last accessed: 10/11/08
Gov.uk. Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: https://www.gov.uk Last accessed: 6 January 2015 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: https://www.mhra.gov.uk Last accessed: 6 January 2015
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 September 2017
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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.