- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Paediatrics and neonatology and Psychiatry
These medicines are not first-line options for insomnia.
Article date: June 2009
Chloral hydrate is an older drug which retains some limited clinical usage. The licensed products in the UK are Welldorm elixir (containing chloral hydrate) and Welldorm tablets (containing a precursor, chloral betaine). Triclofos is a closely related drug, which is metabolised in the liver to the same active metabolite as that formed from chloral. All 3 products have been licensed for many years for short-term treatment of insomnia.
Product information for these medicines has recently been changed to reflect current clinical practice where they are not first-line options for insomnia. The licensed indications have been amended to the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed, as an adjunct to non-pharmacological therapies.
The use of hypnotics in children and adolescents is not generally recommended, and if used should be under the supervision of a specialist. Welldorm tablets and Triclofos are not licensed for use in children. Welldorm elixir is licensed for use in adults and in children age 2 years or older. Treatment in children should be as an adjunct to behavioural therapy and sleep-hygiene management, and should not usually exceed 2 weeks.
The summaries of product characteristics and patient leaflets should be consulted for details of correct dose and other safety information.
See the summary of product characteristics for Triclofos and Welldorm on the electronic Medicines Compendium (eMC) website.
We are aware that chloral hydrate is being used for sedation in children, for example in intensive care units and before diagnostic procedures, whether as off-label use of licensed products or unlicensed medicines. General guidance on prescribers’ responsibilities when using a medicine off-label or using an unlicensed medicine has been published in the April 2009 edition of Drug Safety Update.
Advice for healthcare professionals:
- Welldorm and Triclofos are indicated only for the short-term treatment of severe insomnia which is interfering with normal daily life and where other therapies have failed, as an adjunct to non-pharmacological therapies
- the use of hypnotics in children and adolescents is not generally recommended, and if used should be under the supervision of a specialist. Welldorm elixir can be used in children aged 2 years or older as an adjunct to behavioural therapy and sleep-hygiene management, usually for less than 2 weeks
Article citation: Drug Safety Update June 2009, vol 2 issue 11: 3.