4.1.1 Hypnotics

Drugs used for insomnia not listed below:

Patient information leaflet - NEW Devon CCG Good Sleep Guide

Hypnotics should not be used regularly and are only licensed and recommended for short-term use (2-4 weeks). Z–hypnotics should not exceed four weeks use.

The intermediate-acting barbiturates have a place only in the treatment of severe intractable insomnia in patients already taking barbiturates; they should be avoided in the elderly.

The long-acting barbiturate phenobarbital is still sometimes of value in epilepsy but its use as a sedative is unjustified.

Benzodiazepines

Nitrazepam has not been included as it is not recommended due to its prolonged action which can lead to hangover effects.

Lormetazepam should not be prescribed because of its high acquisition cost.

Temazepam
  • Tablets 10mg, 20mg

CNS Depressants

Zopiclone
  • Tablets 3.75mg, 7.5mg (£1.11 = 7.5mg)

Indications

  • Insomnia (short-term use, up to 4 weeks)

Dose

  • Adult over 18 years, 7.5mg at bedtime; elderly initially 3.75mg at bedtime increased if necessary

Notes

  1. Zopiclone is included as first choice because it has the lowest acquisition cost. Zopiclone is not a controlled drug and is therefore not subject to safe custody and requisition requirements.
  2. Although zopiclone is not a benzodiazepine it acts on the same receptors as benzodiazepine. It is not licensed for long-term use (maximum 4 weeks) and there is evidence of dependence in a small number of patients. It is claimed to not affect sleep architecture.
  3. NICE TA77: Zaleplon, zolpidem and zopiclone for the short-term management of insomnia (April 2004)
Zolpidem
  • Tablets 5mg, 10mg (£1.11 = 10mg)

Indications

  • Insomnia (short-term use, up to 4 weeks)

Dose

  • Adult over 18 years, 10mg at bedtime; elderly or debilitated 5mg at bedtime

Notes

  1. Contraindicated in obstructive sleep apnoea
  2. See NICE TA77 - Zaleplon, zolpidem and zopiclone for the management of insomnia (April 2004)
Melatonin
  • Circadin® tablets m/r 2mg (£15.39 = 30 tablets)

Indications

  • Melatonin is only approved in the formulary for use in children only to aid sleep cycle synchronisation in children with sensory impairment, autistic spectrum disorder, in other neurodisability / neuropsychiatric / neurodevelopmental disorders including ADHD when behavioural measures have been insufficient and also to induce sleep in children undergoing sleep EEG.

Dose

  • Child 3–18 years initially 2mg daily 30-60 minutes before bedtime increased if necessary in steps to 4–6mg daily before bedtime; maximum 10mg daily

Notes

  1. Melatonin should only be used in conjunction with good, normal sleep hygiene. Children should be encouraged to adopt a regular, relaxing bedtime routine avoiding stimulating TV programmes and computer games
  2. Melatonin M/R 2mg tablets are licensed for use in adults over 55, use in children is an 'off label' use. The MHRA state that, where available a licensed preparation should be used where possible in preference to an unlicensed product.
  3. Where a patient cannot swallow Circadin® tablets they may be crushed, which then gives an immediate release product which may be beneficial in some patients. The use of Circadin® in this way will be outside of the product license however this is preferable to using an unlicensed product.
  4. Therapy should be reviewed at least every 6 months (BNF). Periodic review by the specialist paediatrician is recommended at appropriate intervals
  5. Other melatonin products are available and in use often for historical reasons. It is considered appropriate for GPs to initiate discussions with patients and carers about changing to the Circadin® formulation. The discussion should include a consideration about the practicalities of taking/administering the dose. There is no need to refer to a paediatrician simply to ask for a review of formulation but support is available if required.
  6. Due to licensing and cost of the unlicensed liquid it is recommended that melatonin m/r 2mg tablets are used where possible. However there are circumstances where other formulations are required, these would be unlicensed preparations. The cost of these unlicensed preparations can be found in the Drug Tariff, melatonin 5mg/5ml solution is currently £89.90 for 200ml and is the less costly option.
Chloral hydrate
  • Liquid 500mg in 5ml (unlicensed preparation)

Notes

  1. Chloral hydrate liquid 500mg in 5ml is included for specialist use in paediatrics only.

Narcolepsy

Drugs used for narcolepsy not listed below:

Sodium oxybate
  • Oral solution 500mg in 1ml

Indications

  • Narcolepsy with cataplexy

Notes

  1. The routine commissioning of sodium oxybate has been accepted in Devon for the management of narcolepsy with cataplexy in adults aged 19 years and older only in line with specific criteria (see Commissioning Policy for more details).

 

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