Nitrazepam is used to treat short-term sleeping problems (insomnia), such as difficulty falling asleep, frequent awakenings during the night, and early-morning awakening.
Nitrazepam is a hypnotic drug of the benzodiazepine class used for short-term relief from severe, disabling anxiety and insomnia. It also has sedative (calming) properties, as well as amnestic (inducing forgetfulness), anticonvulsant, and skeletal muscle relaxant effects. It was patented in 1961 and came into medical use in 1965.
Nitrazepam is used to treat short-term sleeping problems (insomnia), namely difficulty falling asleep, frequent awakening, early awakening, or a combination of each. Nitrazepam is sometimes tried to treat epilepsy when other medications fail. It has been found to be more effective than clonazepam in the treatment of West syndrome, which is an age-dependent epilepsy, affecting the very young.
In uncontrolled studies, nitrazepam has shown effectiveness in infantile spasms and is sometimes considered when other anti-seizure drugs have failed.However, drowsiness, hypotonia, and most significantly tolerance to anti-seizure effects typically develop with long-term treatment, generally limiting Nitrazepam to acute seizure management.
Treatment should be as short as possible and should be started with the lowest effective dose. The maximum dose should not be exceeded. Generally the duration of treatment varies from a few days to two weeks, with a maximum of four weeks; including the tapering off process. Dosage should be adjusted on an individual basis. If possible, the treatment should be on an intermittent basis. Long-term chronic use is not recommended. The recommended adult dose of nitrazepam when taken for insomnia is 5 mg to 10 mg taken at bedtime.
Adults: 5 mg before retiring. This dose may be increased, if necessary, to 10 mg.
Children below the age of 12 years: Do not use.
Elderly and debilitated patients: 2.5 – 5 mg before retiring, doses should not exceed half those normally recommended for adults.
In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, dosage may need to be reduced.
Nitrazepam belongs to a group of medicines called benzodiazepines. This drug affects central benzodiazepine receptors, which are associated with inhibitory GABA (gamma amino butyric acid)receptors, leading to enhanced GABA binding activity. GABA is a major neurotransmitter in the brain, which causes somnolence, relaxation of muscles, a decrease in anxiety and general central nervous system depression. Nitrazepam has anticonvulsant properties that may be attributed to its ability to bind to voltage-dependent sodium channels. Sustained repetitive firing seems to be limited by benzodiazepines effect of slowing recovery of sodium channels from inactivation.
More common side effects may include: Central nervous system depression, including somnolence, dizziness, depressed mood, fatigue, ataxia, headache, vertigo, impairment of memory, impairment of motor functions, hangover feeling in the morning, slurred speech, decreased physical performance, numbed emotions, reduced alertness, muscle weakness, double vision, and inattention have been reported. Unpleasant dreams and rebound insomnia have also been reported. Nitrazepam is a long-acting benzodiazepine with an elimination half-life of 15–38 hours (mean elimination half-life 26 hours).
Less common side effects may include: Hypotension, faintness, palpitation, rash or pruritus, gastrointestinal disturbances, and changes in libido are less common. Very infrequently, paradoxical reactions may occur, for example, excitement, stimulation, hallucinations, hyperactivity, and insomnia. Also, depressed or increased dreaming, disorientation, severe sedation, retrograde amnesia, headache, hypothermia, and delirium tremens are reported.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health.
Alcohol and other medications that cause drowsiness: People taking this medication should not combine it with alcohol and avoid combining it with other medications, such as narcotic pain relievers, or other sedatives that cause drowsiness. Doing so can cause additional drowsiness and reduced breathing as well as other side effects, which can be dangerous.
Asthma and other respiratory conditions: Nitrazepam may cause increased breathing difficulty for people having an acute asthma attack, or those with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) or other conditions that affect breathing. If you have asthma or any other breathing disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Behavioural and mood changes: This medication may cause mood and psychiatric changes, including aggressiveness, confusion, anxiety, restlessness, and memory lapses. Tell your doctor as soon as possible if you notice any unusual changes in your behaviour.
Complex sleep-related behaviours: There have been reports of complex sleep-related behaviours that have occurred while using nitrazepam and other similar medications to treat difficulty sleeping. People taking nitrazepam have been reported to talk, walk, cook, eat, and drive while they were not fully awake, and did not remember doing these things afterwards. If you experience similar events, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.
Dependence and withdrawal: Physical dependence (a need to take regular doses to prevent physical symptoms) has been associated with benzodiazepines such as nitrazepam. Severe withdrawal symptoms may be experienced if the dose is significantly reduced or suddenly discontinued. These symptoms include seizures, irritability, nervousness, sleep problems, agitation, tremors, diarrhea, abdominal cramps, vomiting, memory impairment, headache, muscle pain, extreme anxiety, tension, restlessness, and confusion. Reducing the dose gradually under medical supervision can help prevent or decrease these withdrawal symptoms.
A temporary condition called rebound insomnia, where the symptoms that led to treatment with nitrazepam come back worse than before, may occur on withdrawal of the medication. It may be accompanied by other reactions including mood changes or anxiety.
Depression: This medication can make some symptoms of depression worse. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, contact your doctor as soon as possible. If you experience feelings of wanting to harm yourself, or notice this in a family member who is taking this medication, seek medical help immediately.
Drowsiness/reduced alertness: Nitrazepam causes drowsiness and sedation. Avoid activities requiring mental alertness, judgment, and physical coordination such as driving or operating machinery until you have determined how this medication affects you. Drinking alcohol can increase the drowsiness effects and should be avoided.
Kidney function: If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: People with reduced liver function or liver disease may experience a stronger effect from the medication than would normally occur. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: Nitrazepam, like other benzodiazepines, can cause harm to an unborn baby if the mother takes it while pregnant. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking nitrazepam, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of nitrazepam for sleep difficulties have not been established for children and adolescents less than 18 years of age.
Nitrazepam tablets should not be used alone to treat depression or anxiety with depression, since suicide may be precipitated in such patients.
In patients with chronic pulmonary insufficiency, and in patients with chronic renal or hepatic disease, dosage may need to be reduced. Benzodiazepines are contraindicated in patients with severe hepatic insufficiency.
Benzodiazepines are not recommended for the primary treatment of psychotic illness. If the patient is awoken during the period of maximum drug activity, recall may be impaired.
In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.
Store Nitrazepam at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store the drugs in the bathroom. Keep all drugs away from reach of children and pets.
