Nitrazepam

Registered South African indications:

• Insomnia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to benzodiazepines (rare cases report rash, angioedema, and hypertension in susceptible individuals)
• Myasthenia gravis
• Severe respiratory insufficiency or respiratory depression
• Sleep apnoea syndrome
• Severe hepatic insufficiency
• Phobic or obsessional states; chronic psychosis
• Pregnancy
• Lactation
• Use in children

Cautions

• Renal impairment
• Mild to moderate hepatic impairment
• Elderly
• Chronic pulmonary insufficiency
• Monotherapy for depression or anxiety with depression 
• Primary treatment for psychotic illness 
• Loss or bereavement
• History of alcoholism or drug abuse
• Personality disorders
• Prolonged use
• High doses
• Abrupt withdrawal
• Hypoalbuminaemia
• Epilepsy
• May impair ability to drive and operate machinery 

Forms avail. in SA and covered in this monograph: tab

Relief of insomnia

• Oral (tab): 5mg, dly at night; Uptitrate to 10mg, dly if necessary; Max treatment duration: 4 weeks including tapering off period

Only indicated when insomnia is severe, disabling, or causing extreme stress

Not established for use in children (see Contraindications)

Pregnancy

• Contraindicated

Breastfeeding

• Contraindicated

Renal Impairment

• Caution; dose adjustment recommended

Hepatic Impairment

• Mild to moderate: Caution; dose adjustment recommended
• Severe: Contraindicated
  Contraindicated in severe hepatic insufficiency

Elderly

• Caution; dose adjustment recommended

Central Nervous System Disorders

• Confusion
• Sleeping disorders
• Insomnia
• Libido fluctuations
• Dependence and abuse of benzodiazepines
• Amnesia
• Depression
• Withdrawal
• Dizziness
• Sedation
• Unsteadiness
• Ataxia
• Drowsiness
• Numbed emotions
• Reduced alertness
• Fatigue
• Disturbance in attention
• Tremor
• Dystonia
• Headache
• Dysarthria

Cardiovascular Disorders

• Hypotension

Respiratory Disorders

• Respiratory depression

Gastrointestinal Disorders

• Nausea
• Gastrointestinal upsets

Hepatobiliary Disorders

• Jaundice

Genitourinary Disorders

• Urinary retention

Musculoskeletal Disorders

• Muscle cramps
• Muscular weakness

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Pruritus
• Dermatitis
• Erythema multiforme
• Stevens-Johnson syndrome

Immune, Blood and Lymphatic System Disorders

• Blood dyscrasias
• Hypersensitivity reactions

Sensory Disorders

• Visual disturbances
• Diplopia 
• Vertigo

• Alcohol
• Antipsychotics
• Tranquillisers
• Hypnotics
• Analgesics
• Anxiolytics
• Sedatives
• Antidepressants
• Narcotic analgesics
• Antiepileptics
• Anaesthetics
• Sedative antihistamines
• Lofexidine
• Nabilone
• Dopaminergics
• Caffeine
• Theophylline
• Cimetidine
• Oestrogen-containing contraceptives
• Disulfiram
• Rifampicin
• Isoniazid
• Ritonavir
• Antihypertensives
• Baclofen
• Tizanidine
• Probenecid
• Antivirals

• Mental status
• Cardiovascular examination 
• Respiratory examination 

Nitrazepam acts on gamma aminobutyric acid (GABA)-associated benzodiazepine receptors in the brain, resulting in increased binding of GABA to GABA-A receptors. This enhances the inhibitory effects of GABA on the brain, including sleepiness, muscular relaxation, and control of anxiety and seizures.

Tablet 5mg

• Arem (Pharmacare)