Chloral Hydrate

Chloral hydrate has been used for many years as a sedative/hypnotic drug. The metabolite (trichloroethanol) is responsible for the pharmacological effect. The proposed mechanisms for CNS depression include potentiating GABAA receptor function, inhibition of excitatory amino acid-activated currents mediated by NMDA, and allosteric modulation of 5-HT3 receptor-mediated depolarization of the vagus nerve.

• Severe insomnia in adults (maximum 2 weeks)
• Severe insomnia in children and adolescents aged 2 years and above with neurodevelopmental disorders

Chloral hydrate has been used for many years as a sedative/hypnotic drug. The metabolite (trichloroethanol) is responsible for the pharmacological effect. Mechanisms for CNS depression include potentiating GABAA receptor function, inhibition of NMDA-mediated excitatory amino acid currents, and allosteric modulation of 5-HT3 receptor-mediated depolarization.

Chloral hydrate potentiates GABAA receptor function and inhibits NMDA receptor-mediated excitatory currents, leading to CNS depression and sleep induction.

Adults: 430-860 mg (15-30 ml) once daily, 15-30 minutes before bedtime. Maximum 2 g/dose.
Elderly: Same as adults (reduce dose in frail elderly or hepatic impairment).
Children (12-18 years): 430-860 mg (15-30 ml) once daily; maximum 2 g/dose.
Children (2-11 years): 30-50 mg/kg (1-1.75 ml/kg); maximum 1 g/dose.
Children under 2 years: Do not use.

Administer as a single daily dose 15-30 minutes before bedtime with water or milk.

If you miss a dose of Chloral Hydrate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.

Common: Ataxia, confusion (especially in elderly), GI irritation.
Serious: Tolerance, dependence, withdrawal symptoms (delirium, hallucinations), QT prolongation.

Use the lowest effective dose for the shortest duration. Do not stop abruptly after prolonged use (taper slowly). Caution in patients with history of alcohol/drug abuse, gastritis, peptic ulcer, liver/kidney disease, QT prolongation risk.

Hypersensitivity; severe hepatic impairment; severe renal impairment; severe cardiac disease; active gastritis, oesophagitis, gastric/duodenal ulcers or perforation; susceptibility to acute porphyria attacks.

No adequate information on drug interactions is available.

Individuals with history of alcohol or drug abuse may be at greater risk for abuse of chloral hydrate.

Little information is available on adverse effects on human pregnancy. Crosses the placenta. Prolonged use may increase risk of hyperbilirubinemia in neonates.

Low levels found in breast milk. Breastfeeding infants may be sedated, but milk concentrations are considerably lower than clinically active doses.

Safety and efficacy in children under 2 years have not been established; do not use.

Elderly patients are more likely to experience ataxia and confusion; use the lowest effective dose in frail elderly.

Hepatic impairment: Mild-moderate: caution; severe: contraindicated.
Renal impairment: Mild-moderate: caution; severe: contraindicated.

Overdose may cause severe CNS depression, respiratory depression, hypotension, arrhythmia. Seek medical attention.

Store below 25°C. Keep the bottle upright in outer carton to protect from light.

Chloral Hydrate