Generic
Nitrazepam
4 brands available in the market
At a glance
Nitrazepam is a benzodiazepine used for insomnia. It enhances the inhibitory effect of GABA to suppress abnormal and excessive activity of nerve cells in the brain, inducing sleep.
Description
Nitrazepam is a benzodiazepine derivative related to diazepam. Unlike barbiturate derivatives, nitrazepam gives way to physiologic sleep by increasing the stimulus threshold of hippocampus and does not inhibit cortical function. After sleep with nitrazepam, patients awaken thoroughly relaxed.
Indications
- Disturbances of sleep of various etiology
- Insomnia of neurotics
- Involutional restlessness
- Sleep disturbances in cerebrosclerotic patients
- Myoclonic seizures
Therapeutic class
Benzodiazepine Hypnotics
Pharmacological class
Benzodiazepine
Pharmacology
Nitrazepam enhances the inhibitory effect of GABA to prevent excessive brain cell activity, depressing the reticular-activating system in the brainstem to induce sleep.
Mechanism of action
Induces sleep by suppressing excessive nerve cell activity in the brain.
Dosage
Adult Dose (Oral):
- 5 mg at night; increase to 10 mg if necessary
Elderly and Debilitated: Half of normal adult dose
Pediatric Dose (Myoclonic seizures):
- 0.3-1.0 mg/kg/day in 3 divided doses
Administration
- Take 30-45 minutes before bedtime
- Take only when you have time to sleep for at least 7 hours
- Swallow tablet whole; do not chew, crush or break
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Common Side Effects:
- Dizziness
- Sedation
- Drowsiness
- Unsteadiness
- Impaired coordination
Precautions & warnings
- Should not be used for more than 4 weeks
- High addiction/habit-forming potential
- Do not stop suddenly (withdrawal symptoms may occur)
- Caution while driving
- Avoid alcohol
- Elderly patients may have reduced muscle tone and increased risk of falls
Contraindications
- Myasthenia gravis
- Narrow-angle glaucoma
- Severe respiratory insufficiency
- Sleep apnoea syndrome
- Severe hepatic impairment
- Porphyria
Drug interactions
- Increased CNS depression with alcohol, barbiturates, TCAs, phenothiazines, morphine derivatives
- Effects may be antagonized by theophylline
- Increased levels/effects with probenecid
- Reduced levels/effects with rifampicin
- May reduce effects of levodopa
Food interactions
Alcohol may cause excessive drowsiness; avoid.
Use in pregnancy
Use in Pregnancy: Nitrazepam is highly unsafe during pregnancy; definite evidence of fetal harm. Not recommended in first 3 months.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Nitrazepam is probably unsafe during breastfeeding; may pass into breast milk and harm the baby.
Pediatric use
Dose established for children (myoclonic seizures).
Geriatric use
Elderly and debilitated patients should receive half dose.
Renal / hepatic impairment
Renal Impairment: Caution in kidney disease; dose adjustment may be needed.
Hepatic Impairment: Not recommended in severe liver disease; caution.
Overdose effects
Overdose: Somnolence, confusion, ataxia, coma, dyspnoea, hypotension, respiratory and cardiovascular depression; gastric lavage, flumazenil treatment.
Storage conditions
Store at room temperature; protect from light and moisture; keep out of reach of children.
Chemical structure
Nitrazepam