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Nitrazepam information from DrugsUpdate  

See Available Brands of Nitrazepam in India

P - Caution when used during pregnancy
L - Caution when used during lactation
FI - Food *
LI - Lab *

Nitrazepam is a type of benzodiazepine drug and is marketed in English-speaking countries under the following brand names: Alodorm, Arem, Insoma, Mogadon, Nitrados, Nitrazadon, Ormodon, Paxadorm, Remnos and Somnite. It is a hypnotic drug with sedative and motor impairing properties, anxiolytic, amnestic, anticonvulsant and skeletal muscle relaxant properties. Nitrazepam is available in 5mg and 10mg tablets. In the Netherlands, Australia, Israel and the United Kingdom it is only available in 5mg tablets.

Pharmacodynamics

Pharmacokinetics

Nitrazepam is a benzodiazepine with a pronounced sleep-inducing activity. It depresses the reticular-activating system in the brainstem by enhancing the inhibitory effect of GABA on brain cells, thus preventing excessive brain activity.

Onset
30-60 minutes.

Duration

6-8 hours.

Absorption

Fairly absorbed from the GI tract (oral). Peak plasma levels in 2-3 hours.

Distribution
Crosses the blood-brain barrier and placenta; enters breast milk (trace amounts). Protein-binding: 87%.

Metabolism

Hepatic by nitroreduction followed by acetylation.

Excretion

Urine (as free or conjugated metabolites); 24-30 hours (elimination half-life).

Nitrazepam Indications / Nitrazepam Uses

Information Not Available

Nitrazepam Adverse Reactions / Nitrazepam Side Effects

Hypotension, palpitation; agitation, aggressiveness, amnesia, ataxia, confusion, delusions, disorientation, dizziness, fatigue, hallucination, hangover, headache, irritability, nightmares, psychoses, rage, restlessness, sedation; rash; changes in libido; constipation, diarrhoea, excessive salivation, heartburn, nausea, vomiting; granulocytopenia, leukopenia; falling, muscle weakness; blurred or double vision; tinnitus (associated with withdrawal); aspiration, increased bronchial secretion, dyspnoea.

Precautions

Information Not Available

Special Precautions

May induce anterograde amnesia; caution patients to have uninterrupted sleep of 7-8 hours after ingestion of dose. May impair ability to drive or operate machinery. Depression, especially if suicidal risk may be present. History of drug abuse or acute alcoholism. Hepatic and renal impairment. Respiratory disease. Debilitated patients. Patients who are at risk of falls. Children, elderly. Pregnancy and lactation.

Other Drug Interactions

CNS depressant effect increased with alcohol, barbiturates, TCAs, phenothiazines, morphine derivatives. Effects may be antagonised by theophylline. Increased levels/effects with probenecid. Reduced levels/effects with rifampicin. May reduce effects of levodopa.

Other Interactions

Food Interaction
Increased CNS depression may occur with valerian, kava kava, St John's wort, gotu kola.

Dosage

Oral
Short-term management of insomnia
Adult: 5 mg at night; increase to 10 mg if necessary.
Elderly: and debilitated patients: ≤normal adult dose.

Oral

Infantile spasms
Child: Infants: 125 mcg/kg bid; gradually increase to 250-500 mcg/kg bid.

Food(before/after)

May be taken with or without food.

List of Contraindications

Nitrazepam and Pregnancy

Caution when used during pregnancy

Nitrazepam and Lactation

Caution when used during lactation

Nitrazepam and Children

Nitrazepam is not recommended for use in those under 18. Use in very young children may be especially dangerous. Children treated with nitrazepam for epilepsies may develop tolerance within months of continued use, with dose escalation often occurring with prolonged use. Sleepiness, deterioration in motor skills and ataxia were common side effects in children with tuberous sclerosis treated with nitrazepam. The side effects of nitrazepam may impair the development of motor and cognitive skills in children treated with nitrazepam. Withdrawal of nitrazepam only occasionally resulted in a return of seizures and some children withdrawn from nitrazepam appeared to improve. Development, e.g. able to walk at 5 years was impaired in many children taking nitrazepam but was not impaired with several other non benzodiazepine antiepileptic agents. It has been recommended that children being treated with nitrazepam should be reviewed and have their nitrazepam gradually discontinued whenever appropriate.

Nitrazepam and Geriatic

Nitrazepam has been found to be dangerous in elderly patients due to a significant increased risk of falls. This increased risk is probably due to the persisting drug effects of nitrazepam well into the next day. Nitrazepam is a particularly unsuitable hypnotic for the elderly as it induces a disability characterised by general mental deterioration, inability to walk, incontinence, dysarthric, confusion, prone to stumbling, falls and disoriention which can occur from doses as low as 5 mg. The nitrazepam induced symptomatology can lead to a misdiagnosis of brain disease in the elderly e.g. dementia and can also lead to the symptoms of postural hypotension which may also get misdiagnosed. It was reported that a geriatric unit was seeing as many as 7 patients a month with nitrazepam induced disabilities and health problems. It was recommended that nitrazepam should join the barbiturates in not being prescribed to the elderly. Only nitrazepam and lorazepam were found to increase the risk of falls and fractures in the elderly. CNS depression occurs much more frequently in the elderly and is especially common in doses above 5 mg of nitrazepam. Both young and old patients report sleeping better after 3 nights use of nitrazepam however they also report feeling less awake and are slower on psychomotor testing up to 36 hours after intake of nitrazepam. The elderly showed cognitive deficits, making significantly more mistakes in psychomotor testing than younger patients despite similar plasma levels of the drug, suggesting that the elderly are more sensitive to nitrazepam due to increased sensitivity of the aging brain to nitrazepam. Confusion and disorientation can result from chronic nitrazepam administration to elderly subjects. Also the effects of a single dose of nitrazepam may last up to 60 hours after administration.

Nitrazepam and Other Contraindications

Myasthenia gravis, narrow-angle glaucoma, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic impairment, porphyria.

Storage

Oral
Store at room temperature. Protect from light and moisture.

Lab interference

Oral
Store at room temperature. Protect from light and moisture.

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