Temazepam

Registered South African indications:

• Insomnia
• Premedication 

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Idiosyncrasy to benzodiazepine derivatives
• Insomnia due to depression

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Prolonged use
• Abrupt withdrawal 
• High doses 
• History of alcoholism or drug abuse
• Organic cerebral changes
• Arteriosclerosis
• Cardiorespiratory insufficiency
• Primary treatment of psychotic illness
• Bereavement 
• Personality disorders
• Galactose intolerance
• Lapp lactase deficiency
• Glucose-galactose malabsorption
• May affect ability to drive and operate machinery 
• Concomitant use of opioids

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

Insomnia - severe, disabling

• Oral (cap): 10-30mg, 30min before retiring; Max treatment duration: 4 weeks

Patients should ensure that they will be able to have an uninterrupted sleep of 7-8hrs

Premedication 
- Minor surgical and investigative procedures when hospital admission is not essential

• Oral (cap): 20-40mg, 30-60min prior to procedure 

Not established for use in children below 18 years

Pregnancy

• Caution
• Safety in pregnancy has not been established

Breastfeeding 

• Caution
• It is not known whether temazepam is excreted in human milk. Caution should be exercised when temazepam is given to a nursing woman since there is evidence that benzodiazepines are excreted in human breast milk

Renal Impairment 

• Caution
  The usual precautions for treating patients with impaired renal function should be observed

Hepatic Impairment

• Caution
  The usual precautions for treating patients with impaired hepatic function should be observed

Elderly

• Caution; dose adjustment recommended  

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warning

Porphyria Information

• Not porphyrinogenic (NP) 

Central Nervous System Disorders

• Drowsiness
• Restlessness
• Agitation
• Irritability
• Aggressiveness
• Delusion
• Rage
• Hallucinations
• Inappropriate behaviour
• Numbed emotions
• Reduced alertness
• Confusion
• Fatigue
• Headache
• Dizziness
• Muscle weakness
• Ataxia
• Slurred speech
• Restless sleep
• Nightmares
• Dysarthria
• Tremor
• Changes in libido
• Anterograde amnesia 
• Depression 
• Psychiatric reactions
• Paradoxical reactions
• Dependance 
• Withdrawal syndrome 
• Seizures 

Cardiovascular Disorders

• Hypotension 

Respiratory Disorders

• Respiratory depression

Gastrointestinal Disorders

• Dry mouth 
• Hypersalivation 

Hepatobiliary Disorders

• Jaundice 

Genitourinary Disorders

• Incontinence
• Urinary retention

Skin and Subcutaneous Tissue Disorders

• Rash

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Blood dyscrasias

Sensory Disorders

• Visual disturbances
• Diplopia 

• Central nervous system depressants
• Antihypertensives
• Antivirals
• Clozapine
• Disulfiram
• Dopaminergics
• Muscle relaxants
• CYP450 inhibitors 
• Antiepileptic drugs

• Respiratory examination
• Cardiovascular examination

Temazepam binds to stereospecific benzodiazepine receptors on the postsynaptic gamma aminobutyric acid (GABA) neuron at several sites within the central nervous system, including the limbic system and reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results from increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization and stabilization.

Capsule 10mg

• Normison (Pharmacare) originator

Capsule 20mg

• Normison (Pharmacare) originator