chloral hydrate: clinical use

Prescribing considerations

• Reserve licensed use for severe insomnia affecting daily life after behavioural and pharmacological approaches have failed, alongside non-pharmacological measures.
• Paediatric licensed use is restricted to patients aged 2 years or over with suspected or confirmed neurodevelopmental disorder and requires medical-specialist supervision.
• Assess misuse, dependence and withdrawal risks, particularly with a history of alcohol or substance dependence.
• Avoid abrupt discontinuation after prolonged exposure because delirium and hallucinations may occur.
• Use caution with gastrointestinal disease, mild-to-moderate hepatic or renal impairment, frailty, electrolyte disturbance, bradyarrhythmia and long-QT risk.

Contraindications and cautions

• Hypersensitivity to chloral hydrate or an excipient
• Severe hepatic impairment
• Renal failure or severe renal impairment
• Severe cardiac disease
• Active gastritis, oesophagitis, gastric or duodenal ulceration or perforation
• Susceptibility to acute porphyria attacks

Monitoring

• Sedation, respiratory depression, confusion, coordination and falls risk
• Tolerance, dependence, misuse or withdrawal
• Cardiac rhythm and relevant electrolytes when QT-risk factors or interacting medicines are present
• Hepatic and renal status where impairment is suspected
• Prothrombin time or INR when treatment changes in a patient taking an anticoagulant
• Interpret thyroid-function tests cautiously because chloral hydrate may interfere with results

Clinical pharmacology

Chloral hydrate is absorbed from the gastrointestinal tract and rapidly reduced to active trichloroethanol. Inactive metabolites are eliminated mainly in urine. Trichloroethanol clearance is substantially slower in neonates and children under 2 years.

Formulation and product differences

• Selected licensed oral solutions contain either 143.3 mg/5 ml or 500 mg/5 ml; verify the concentration to prevent measurement errors.
• Neither selected solution requires dilution.
• The 500 mg/5 ml pack includes a graduated oral syringe and bottle adaptor.
• Both selected products have an in-use shelf life of 28 days and should be stored below 25°C, upright and protected from light.

Oral solution

Route: Oral

Strengths: 143 mg/5 mL, 500 mg/5 mL