4.1.1 Hypnotics

Drugs used for insomnia not listed below:

Patient information leaflet - NHS 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.

CNS depressants

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

Indications

  • Insomnia including nocturnal and early awakening (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. NICE TA77: Zaleplon, zolpidem and zopiclone for the short-term management of insomnia (April 2004). The recommendations originally included zaleplon, but this drug no longer has a marketing authorisation in the UK.
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. NICE TA77: Zaleplon, zolpidem and zopiclone for the short-term management of insomnia (April 2004). The recommendations originally included zaleplon, but this drug no longer has a marketing authorisation in the UK.
Melatonin
  • Circadin® tablets m/r 2mg (£15.39 = 30 tablets)

Indications and dose

  • Child 1 month–18 years: initially 2mg daily before bedtime increased if necessary after 1–2 weeks to 4–6mg daily before bedtime; maximum 10mg daily (unlicensed in this age group)

Notes

  1. Melatonin tablets may be prescribed in primary care on the advice of a specialist for use 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.
  2. 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.
  3. Therapy should be reviewed at least every 6 months (BNF). Periodic review by the specialist paediatrician is recommended at appropriate intervals
  4. 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.

Narcolepsy

Drugs used for narcolepsy not listed below:

Pitolisant
  • Tablets 4.5mg, 18mg (£310.00 = 30 tablets)

Indications

  • Narcolepsy with cataplexy in adults aged 19 years and older

Dose

  • Initially 9 mg once daily for 1 week, then increased if necessary to 18 mg once daily for 1 week, then increased if necessary to 36 mg once daily, dose to be taken in the morning with breakfast, dose can be decreased (down to 4.5 mg per day) or increased (up to 36 mg per day) according to response and tolerance.
  • Refer to SPC for information regarding use in hepatic or renal impairment

Notes

  1. Narcolepsy should be diagnosed and treatment initiated by a specialist physician (this includes dose titration and stabilisation)
  2. Manufacturer recommends effective contraception throughout treatment and for 21 days after stopping in women of childbearing potential. Pitolisant/metabolites may reduce the effectiveness of hormonal contraceptives; therefore, an alternative method of effective contraception should be used
  3. The routine commissioning of pitolisant hydrochloride is accepted in Devon only for the treatment of narcolepsy with cataplexy in adults aged 19 years and over who would otherwise be eligible for treatment with sodium oxybate (see Commissioning Policy for more details)
  4. Pitolisant is not routinely commissioned for the treatment of patients with narcolepsy without cataplexy
Sodium oxybate
  • Oral solution 500mg in 1ml (£360.00 = 180ml)

Indications

  • Narcolepsy with cataplexy in adults (aged 19 years and older)
  • Narcolepsy with cataplexy in children (aged under 19 years) (hospital only)

Notes

  1. For adults (aged over 19 years and older), refer to individual shared care guidelines
  2. To avoid unnecessary out of pocket expenses, practices or pharmacies should order Xyrem® direct from Alloga UK via allogauk.orders@alloga.co.uk or 01773 441702 (please state which wholesaler you wish to be invoiced through)
  3. The routine commissioning of sodium oxybate is 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).
  4. Refer to NHS England clinical commissioning policy for use in children (hospital only)
Last updated: 13-08-2020

 

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