flurazepam monohydrochloride: clinical use

Prescribing considerations

• Confirm that insomnia meets the licensed severity threshold and investigate underlying causes.
• Assess medicines, alcohol or substance misuse history, respiratory status, hepatic and renal function, falls risk and psychiatric history.
• Discuss tolerance, dependence, addiction, rebound insomnia and withdrawal, with an agreed discontinuation strategy.
• Avoid using flurazepam alone for depression or anxiety associated with depression.
• Account for greater residual effects in older or debilitated patients.

Contraindications and cautions

• Hypersensitivity to flurazepam, another benzodiazepine or an excipient
• Myasthenia gravis
• Severe pulmonary insufficiency or respiratory depression
• Sleep apnoea syndrome
• Severe hepatic insufficiency
• Phobic or obsessional states, or chronic psychosis
• Spinal or cerebellar ataxia
• Use in children

Monitoring

• Clinical benefit and continuing need
• Daytime sedation, cognitive or psychomotor impairment and driving risk
• Falls, ataxia and muscle weakness
• Respiratory depression, particularly with opioids or other sedatives
• Tolerance, misuse, dependence, addiction and withdrawal symptoms
• Paradoxical reactions, worsening depression or suicidal thinking

Clinical pharmacology

Flurazepam positively modulates GABA-A receptor activity. It undergoes extensive first-pass metabolism to active metabolites; N1-desalkyl-flurazepam has a prolonged, highly variable elimination half-life that is further extended in older people and can lead to accumulation.

Formulation and product differences

• The selected product is an oral hard capsule that should be swallowed intact.
• It contains lactose and is unsuitable for people with specified rare hereditary disorders of galactose or glucose-galactose handling.
• The selected capsule has a black cap and opaque grey body and contains iron oxide and titanium dioxide colouring agents.

Capsule

Route: Oral

Strengths: 15 mg, 30 mg