Drugs List

Therapeutic Indications

Uses

Severe insomnia (short-term treatment)

Short-term treatment of severe insomnia in adults in which normal daily life is interrupted and other therapies have failed. Treatment should be as an adjunct to non-pharmacological therapies.

Short-term treatment of severe insomnia in children and adolescents aged 2 years and above with a neurodevelopmental disorder, and in which normal daily life is interrupted and other therapies have failed. Treatment should be as an adjunct to sleep hygiene management and behavioural therapy. Use in children and adolescents is not generally recommended and if used should be under the supervision of a medical specialist.

Unlicensed Uses

Sedation for painless procedures - children

Contraindications

Acute porphyria
Breastfeeding
Duodenal ulcer
Gastric ulcer
Gastritis
Gastrointestinal perforation
Long QT syndrome
Oesophagitis
Pregnancy
Severe cardiac disorder
Severe hepatic impairment
Severe renal impairment
Torsade de pointes

Precautions and Warnings

Children under 18 years
Debilitation
Elderly
Family history of long QT syndrome
Cardiac disorder
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of alcohol abuse
History of drug misuse
History of gastritis
History of gastrointestinal perforation
History of gastrointestinal ulceration
History of oesophagitis
History of torsade de pointes
Mild hepatic impairment
Mild renal impairment

Correct electrolyte disorders before treatment
Advise patient drowsiness may affect ability to drive or operate machinery
Children under 18: Treatment to be initiated/supervised by a specialist
Contains sodium benzoate: may increase risk of jaundice in neonates
Contains glucose
Oral solution contains glycerol
Some formulations contain propylene glycol
Some formulations contain sunset yellow (E110); may cause allergic reaction
Avoid contact with skin and mucous membranes
Repeated use is not recommended
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients with a history of alcoholism and drug abuse
Monitor serum electrolytes
Potential for drug abuse
May cause dependence
May interfere with thyroid function tests
Avoid abrupt withdrawal
Consider dose reduction in hepatic impairment
Consider dose reduction in renal impairment
Maintain treatment at the lowest effective dose
Reduce dose in debilitated patients
Reduce dose in elderly
Maintain treatment for the shortest possible duration
Maximum duration of treatment is 2 weeks
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient possible drowsiness next morning

Pregnancy and Lactation

Pregnancy

Chloral hydrate is contraindicated in pregnancy.

Use of chloral hydrate during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of chloral hydrate during pregnancy. Potential risks are unknown, however chloral hydrate is known to cross the human placenta at term. Some data suggests that prolonged administration of sedative doses to neonates increases the risk of hyperbilirubinaemia.

Lactation

Chloral hydrate is contraindicated during breastfeeding.

Use of chloral hydrate when breastfeeding is contraindicated by the manufacturer. Chloral hydrate is present in human breast milk at low levels. However, sedation has been reported in breastfeeding infants. LactMed (2018) suggests other sedative-hypnotics are preferred during breastfeeding due to the long-half of the active metabolite of chloral hydrate.

Side Effects

Abdominal distension
Accidental injury
Allergic skin reactions
Anxiety
Arrhythmias
Ataxia
Bowel necrosis
Bowel perforation
Confusion
Delirium
Dependence
Dyspnoea
Excitement
Falls
Flatulence
Gastric irritation
Gastritis
Headache
Hyperactivity
Hypersensitivity reactions
Ketonuria
Nausea
Prolongation of QT interval
Rash
Renal injury
Respiratory depression
Tolerance
Vomiting
Withdrawal symptoms

Presentation

Oral formulations of chloral hydrate.

Drugs List

Therapeutic Indications

Uses

Severe insomnia (short-term treatment)

Short-term treatment of severe insomnia in adults in which normal daily life is interrupted and other therapies have failed. Treatment should be as an adjunct to non-pharmacological therapies.

Short-term treatment of severe insomnia in children and adolescents aged 2 years and above with a neurodevelopmental disorder, and in which normal daily life is interrupted and other therapies have failed. Treatment should be as an adjunct to sleep hygiene management and behavioural therapy. Use in children and adolescents is not generally recommended and if used should be under the supervision of a medical specialist.

Unlicensed Uses

Sedation for painless procedures - children

Dosage

Each dose should be taken as a single dose once a day, with water or milk, 15 to 30 minutes before bedtime.

Adults

Children

Contraindications

Acute porphyria
Breastfeeding
Duodenal ulcer
Gastric ulcer
Gastritis
Gastrointestinal perforation
Long QT syndrome
Oesophagitis
Pregnancy
Severe cardiac disorder
Severe hepatic impairment
Severe renal impairment
Torsade de pointes

Precautions and Warnings

Children under 18 years
Debilitation
Elderly
Family history of long QT syndrome
Cardiac disorder
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
History of alcohol abuse
History of drug misuse
History of gastritis
History of gastrointestinal perforation
History of gastrointestinal ulceration
History of oesophagitis
History of torsade de pointes
Mild hepatic impairment
Mild renal impairment

Correct electrolyte disorders before treatment
Advise patient drowsiness may affect ability to drive or operate machinery
Children under 18: Treatment to be initiated/supervised by a specialist
Contains sodium benzoate: may increase risk of jaundice in neonates
Contains glucose
Oral solution contains glycerol
Some formulations contain propylene glycol
Some formulations contain sunset yellow (E110); may cause allergic reaction
Avoid contact with skin and mucous membranes
Repeated use is not recommended
Consider monitoring ECG in patients at risk of QT prolongation
Monitor patients with a history of alcoholism and drug abuse
Monitor serum electrolytes
Potential for drug abuse
May cause dependence
May interfere with thyroid function tests
Avoid abrupt withdrawal
Consider dose reduction in hepatic impairment
Consider dose reduction in renal impairment
Maintain treatment at the lowest effective dose
Reduce dose in debilitated patients
Reduce dose in elderly
Maintain treatment for the shortest possible duration
Maximum duration of treatment is 2 weeks
Advise that effects are potentiated by CNS depressants (including alcohol)
Advise patient possible drowsiness next morning

Pregnancy and Lactation

Pregnancy

Chloral hydrate is contraindicated in pregnancy.

Use of chloral hydrate during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of chloral hydrate during pregnancy. Potential risks are unknown, however chloral hydrate is known to cross the human placenta at term. Some data suggests that prolonged administration of sedative doses to neonates increases the risk of hyperbilirubinaemia.

Lactation

Chloral hydrate is contraindicated during breastfeeding.

Use of chloral hydrate when breastfeeding is contraindicated by the manufacturer. Chloral hydrate is present in human breast milk at low levels. However, sedation has been reported in breastfeeding infants. LactMed (2018) suggests other sedative-hypnotics are preferred during breastfeeding due to the long-half of the active metabolite of chloral hydrate.

Side Effects

Abdominal distension
Accidental injury
Allergic skin reactions
Anxiety
Arrhythmias
Ataxia
Bowel necrosis
Bowel perforation
Confusion
Delirium
Dependence
Dyspnoea
Excitement
Falls
Flatulence
Gastric irritation
Gastritis
Headache
Hyperactivity
Hypersensitivity reactions
Ketonuria
Nausea
Prolongation of QT interval
Rash
Renal injury
Respiratory depression
Tolerance
Vomiting
Withdrawal symptoms

Withdrawal Symptoms and Signs

Abrupt discontinuation should not be undertaken in patients receiving prolonged treatment with chloral hydrate. Sudden withdrawal of the drug may cause delirium and hallucinations. Slowly withdraw chloral hydrate.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: August 2014

Reference Sources

Summary of Product Characteristics: Chloral Hydrate 500mg/5ml Oral Solution. Marlborough Pharmaceuticals Ltd. Revised August 2021.

Summary of Product Characteristics: Welldorm Elixir/Chloral Hydrate 143mg/5ml Oral Solution. Marlborough pharmaceuticals Ltd. Revised April 2022.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Chloral Hydrate. Last revised: 31 October 2018
Last accessed: 08 April 2022

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 September 2022