Adults: Chloral hydrate oral solution is indicated for the short-term treatment (maximum 2 weeks) of severe insomnia that significantly interferes with normal daily activities, especially when other therapies (both behavioral and pharmacological) have been ineffective. It should be used as an adjunct to non-pharmacological measures.

Children and adolescents aged 2 years and above: Chloral hydrate oral solution is indicated for short-term treatment (maximum 2 weeks) of severe insomnia in children and adolescents, particularly those with suspected or confirmed neurodevelopmental disorders, when insomnia disrupts normal daily functioning and other treatments have failed. It should be used alongside behavioral therapy and sleep hygiene practices. Routine use in this group is not generally recommended and, if used, must be under specialist medical supervision.

Chloral hydrate has long been used as a sedative and hypnotic agent in both human and veterinary medicine. Its pharmacological activity is mainly due to its active metabolite, trichloroethanol. The drug produces central nervous system depression through multiple mechanisms, including enhancement of GABAA receptor activity, inhibition of excitatory neurotransmission mediated by N-methyl-D-aspartate (NMDA), and modulation of 5-hydroxytryptamine (serotonin) receptor pathways affecting vagal nerve activity.

The treatment should be as short as possible and should not exceed the maximum treatment period of 2 weeks. Repeat courses of chloral hydrate are not recommended and can only be administered following medical specialist re-assessment since the risk of abuse and dependence increases with the duration of treatment. Following prolonged treatment with chloral hydrate the dose should be slowly tapered before discontinuation. The use of Chloral Hydrate Oral Solution in children and adolescents is not generally recommended and if used should be under the supervision of a medical specialist. Chloral Hydrate 143 mg/5 ml Oral Solution should be administered as a single daily dose, between 15 to 30 minutes before bedtime with water or milk.

• Adults: The usual dose is 430–860 mg (15–30 ml of the 143 mg/5 ml strength). Higher doses should not exceed a maximum of 2 g chloral hydrate (70 ml of the 143 mg/5ml strength) per dose.
• Elderly: Dosage as for adults, except for the frail elderly or those with hepatic impairment where a reduction in dose may be appropriate (see section 4.4).
• Children 12 years and over: The usual dose is 430–860 mg (15–30 ml of the 143 mg/5 ml strength). Higher doses should not exceed a maximum of 2 g chloral hydrate (70 ml of the 143 mg/5 ml strength) per dose.
• Children (between 2 and 11 years): 30–50 mg/kg (1–1.75 ml/kg of the 143 mg/5 ml strength) of bodyweight. The dose should not exceed 1 g chloral hydrate (35 ml of the 143 mg/5 ml strength) per dose.
• Children under 2 years: Chloral hydrate should not be used because the safety and efficacy of chloral hydrate in children aged under 2 years has not been established.

• Hypersensitivity to chloral hydrate or any of its components
• Patients with severe hepatic impairment
• Patients with severe renal impairment
• Patients with severe cardiac disease
• Patients with active gastritis, esophagitis, gastric or duodenal ulcers, or gastrointestinal perforation
• Patients prone to acute attacks of porphyria

Pregnancy: Limited data are available regarding the safety of chloral hydrate in human pregnancy. It is known to cross the placenta at term; however, use in a small number of pregnancies has not shown a clear increase in congenital abnormalities. Some evidence suggests that prolonged use in neonates may increase the risk of hyperbilirubinemia.

Breast Feeding: Small amounts of chloral hydrate are excreted into breast milk. Although infants may experience mild sedation, the levels detected in milk are generally much lower than therapeutic plasma concentrations and are unlikely to cause significant adverse effects.

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration. Tolerance, dependence, withdrawal symptoms, and misuse have been reported with chloral hydrate. Abrupt discontinuation should be avoided in patients on prolonged therapy, as it may lead to withdrawal symptoms such as delirium and hallucinations. Gradual tapering is recommended. Patients with a history of alcohol or substance abuse may have an increased risk of misuse and should be carefully assessed and monitored during treatment.

Gastrointestinal disorders: Use with caution in patients with a history of gastritis, esophagitis, or gastric/duodenal ulceration. It is contraindicated in active gastrointestinal conditions such as gastritis, esophagitis, ulcers, or perforation.

Hepatic and renal impairment: Use cautiously in mild to moderate hepatic or renal impairment; contraindicated in severe cases.

Elderly patients: Older individuals are more susceptible to adverse effects such as ataxia and confusion, which may increase the risk of falls and injury. Use the lowest effective dose in frail elderly patients.

QT prolongation: Use cautiously in patients with electrolyte imbalance (e.g., low potassium), bradycardia, congenital long QT syndrome, or other cardiac disorders.

Pediatric population: Due to immature hepatic metabolism in neonates and children under 2 years, there is a risk of prolonged half-life and increased adverse effects.

Hepatic impairment: Contraindicated in severe hepatic impairment. Dose adjustment may be required in mild to moderate impairment as the drug is extensively metabolized in the liver.

Renal impairment: Contraindicated in renal failure or severe renal impairment. Dose adjustment may be necessary in mild to moderate impairment.

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