Flurazepam

Registered South African indications:

• Insomnia

Contraindications 

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other benzodiazepines
• Severe hepatic impairment
• Children
• Myasthenia gravis
• Severe pulmonary insufficiency
• Respiratory depression 
• Phobic or obsessional states
• Chronic psychosis
• Sleep apnoea syndrome
• Spinal and cerebellar ataxia

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Mild to moderate hepatic impairment  
• Elderly
• Children and adolescents
• Chronic respiratory insufficiency
• Monotherapy for depression or anxiety associated with depression
• History of alcoholism or drug abuse
• Personality disorders
• Primary treatment of psychotic illness
• Cases of loss or bereavement
• Spinal or cerebellar ataxia
• Acute intoxication with alcohol, sedative agents, hypnotic agents, analgesics or psychotropic agents (neuroleptic agents, antidepressants, lithium)
• High doses and/or prolonged use
• Repeated use for a few weeks
• Abrupt withdrawal
• May impair ability to drive and operate machinery

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

Insomnia - severe

• Oral (cap): 15-30mg, dly, before bed; Max duration: 4 weeks; Max: 60mg/24hrs

Dosage should be determined on an individual basis taking into account the severity of the insomnia and the patient's response to treatment

15mg is optimal for most patients and this ensures a full night's sleep with minimal residual effects on wakening. Patients with severe insomnia may require 30 mg (but no more than 60 mg), but residual effects on awakening, associated with an anxiolytic effect, are more frequent at this dose

Long-term chronic use is not recommended. Treatment should, if possible, be on an intermittent basis

In patients with chronic pulmonary insufficiency,  the dosage may need to be reduced

Tablets should be swallowed whole, without chewing

See additional prescribing points

Not established for use in children

Pregnancy

• Caution
• There is no evidence as to medicine safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. Do not use during pregnancy, especially during the first and last trimesters, unless there are compelling reasons
• If the product is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant
• Administration of benzodiazepines in the last trimester of pregnancy or during labour has been reported to produce irregularities in the foetal heart rate, and hypotonia, poor sucking and hypothermia and moderate respiratory depression in the neonate
• Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period  

Breastfeeding

• Caution; not recommended
• There is insufficient information on the excretion of flurazepam and/or metabolites into human milk. However, in common with other benzodiazepines, its passage into breast milk might be expected. Thus, the use of flurazepam in mothers who are breastfeeding is not recommended

Renal Impairment  

• Caution; dose adjustment recommended
  Oral (cap): Initial: 15mg, dly; In general, should not be exceeded

Hepatic Impairment 

• Mild to moderate: Caution; dose adjustment recommended 
  Oral (cap): Initial: 15mg, dly; In general, should not be exceeded
• Severe: Contraindicated

Elderly

• Caution; dose adjustment recommended
  Oral (cap): Initial: 15mg, dly; Should not be exceeded
  If organic brain changes are present, the dosage should not exceed 15 mg

Porphyria Information

• Not classified (NC)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders 

• Emotional poverty
• Confusional state
• Hallucinations
• Dependence
• Withdrawal syndrome
• Rebound effect
• Depression
• Paradoxical drug reactions
  - Anxiety
  - Sleep disorders
  - Insomnia
  - Nightmares
  - Restlessness
  - Agitation
  - Irritability
  - Aggression
  - Delusion
  - Psychotic disorder
  - Abnormal behaviour
  - Emotional disturbances
  - Suicide attempt
  - Suicidal ideation
• Somnolence
• Decreased alertness
• Ataxia
• Dizziness
• Headache
• Extrapyramidal disorder
• Anterograde amnesia
• Mood changes
• Fatigue

Cardiovascular Disorders 

• Hypotension

Respiratory Disorders  

• Respiratory depression

Gastrointestinal Disorders 

• Abdominal discomfort
• Nausea

Hepatobiliary Disorders

• Jaundice
• Increased hepatic enzymes

Genitourinary Disorders  

• Urinary retention
• Libido disorder

Musculoskeletal Disorders  

• Muscle weakness
• Increased risk of falls and fractures in the elderly

Skin and Subcutaneous Tissue Disorders  

• Skin reactions
• Rash

Immune, Blood and Lymphatic System Disorders  

• Hypersensitivity
  - Angioedema
• Thrombocytopenia
• Leukopenia
• Agranulocytosis
• Pancytopenia 

Sensory Disorders 

• Visual impairment
• Diplopia
• Dysgeusia
• Vertigo

• Central nervous system depressants
• Barbiturates
• Antipsychotics
• Sedative/hypnotic agents
• Anxiolytics
• Antidepressants
• Narcotic analgesics
• Opioids
• Alcohol
• Sedative antihistamines
• Anticonvulsants
• Anaesthetics
• Antihypertensives  
• Beta blockers
• Theophylline
• Aminophylline
• Antiepileptics
• Hydantoins
• Muscle relaxants
• CYP450 inhibitors
• Cimetidine
• Omeprazole
• Disulfiram
• CYP450 inducers
• Rifampicin
• Lithium
• Psychotropic agents
• Neuroleptic agents

None routine. Specific cases may require

• Mental health status (including dependency)
• Respiratory function

Precautions for flurazepam dosing

• Treatment should be as short as possible and should be started with the lowest recommended 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
• In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status. Long-term chronic use is not recommended
• Flurazepam is a long-acting benzodiazepine so the patient must be regularly checked to reduce the dosage or frequency of administration if necessary to prevent overdose due to accumulation
• Flurazepam should not be used alone to treat depression or anxiety associated with depression, since suicide may be precipitated in such patients

General precautions for benzodiazepine use

• Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. Specialist help may be appropriate. Little is known regarding the efficacy or safety of benzodiazepines in long-term use
• When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop
• Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse
• Benzodiazepines are not recommended for the primary treatment of psychotic illness
• In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines
• If a decision is made to prescribe flurazepam concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible. The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients or their caregivers to be aware of these symptoms
• Some loss of efficacy (tolerance) to the hypnotic effects of short-acting benzodiazepines may develop after repeated use for a few week
• Use of benzodiazepines may lead to the development of physical and psychological dependence. The dependence potential of the benzodiazepines is low, particularly when limited to short-term use, but this increases when high doses are used, especially when given over long periods. This is particularly so in patients with a history of alcoholism or drug abuse or in patients with marked personality disorders. Regular monitoring in such patients is essential, routine repeat prescriptions should be avoided and treatment should be withdrawn gradually
• Rebound insomnia and anxiety may occur upon withdrawal of treatment as a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur
• Benzodiazepines may induce anterograde amnesia. The condition usually occurs 1-2 hours after ingesting the product and may last up to several hours. Therefore, to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7 to 8 hours. If the patient is awoken during the period of maximum drug activity, recall may be impaired

Flurazepam is a psychotropic substance from the class of 1,4-benzodiazepines. Flurazepam binds to specific benzodiazepine receptors located on GABA-ergic neurones and potentiates the inhibitory actions of GABA-ergic neurones in the nervous system.

Capsule 15mg

• Dalmadorm (Meda) originator

Capsule 30mg

• Dalmadorm (Meda) originator