MTW NHS Trust West Kent CCG

Drug Status Key

  • Preferred
  • Second Line
  • Third Line
  • Specialist Initiation
  • Hospital Only
  • Not Approved for Formulary

Drug Safety Update

 Drugs and driving: blood concentration limits to be set for certain controlled drugs in a new legal offence, July 2014. See also the drugs and driving: the law government webpage for more details

October 2021: Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication

NICE Guidance (see also drug-specific links below)

 TA77 Guidance on the use of zaleplon, zolpidem and zopiclone for the short-term management of insomnia, April 2004

NPPG Position Statement

  December 2021: Off label use of Chloral Hydrate in the Management of Intrusive Movement and Motor Disorders in Children and Young People

Local Guidance

Please see here for local guidance on melatonin

Melatonin MR tablets are included in the formulary for "off label" use in the treatment of sleep disorders in children with conditions such as visual impairment, cerebal palsy, ADHD and learning difficulties. These tablets may be crushed and mixed with water, milk, yoghurt or fruit juice for administration; this gives an immediate release profile.

For the purposes of single dose prescriptions of melatonin for sleep EEG in children at MTW, melatonin tablets (Adaflex) may be dispensed.

For daridorexant - see under drug below for prescribing guidance

Pack Price
28 tablet £1.32
Pack Price
28 tablet £1.47
30 tablet
Pack Price
28 tablet £23.71
500 tablet
7 tablet
Pack Price
250 tablet
28 tablet (2 x 14 tablets) £33.38

Prior to initiation of daridorexant patients should be screened for the following:

  • Depression
  • Generalised anxiety disorder
  • Panic disorder
  • Obsessive compulsive disorder
  • Post traumatic stress disorder
  • Social anxiety disorder
  • Chronic Fatigue Syndrome
  • Chronic Pain
  • Irritable bowel syndrome

If any of the above are suspected the patient should be referred to Talking Therapies (for access to CBT) in the first instance.

Daridorexant is recommended for treating insomnia in adults with symptoms lasting for 3 nights or more per week for at least 3 months, and whose daytime functioning is considerably affected, only if:

  • cognitive behavioural therapy for insomnia (CBTi) has been tried but not worked, or
  • CBTi is not available or is unsuitable.

The length of treatment should be as short as possible. Treatment with daridorexant should be assessed within 3 months of starting and should be stopped in people whose long-term insomnia has not responded adequately. If treatment is continued, assess whether it is still working at regular intervals.

The initiating clinician is responsible for the 3 month assessment of efficacy.

Contraindications:

  • Hypersensitivity to any of the ingredients or excipients.
  • Narcolepsy
  • Concomitant use of CYP 3A4 inhibitors

Precautions include:

  • Elderly- use with caution. Limited data is available in those >75 years and no data >85 years.
  • Severe obstructive sleep apnoea (OSA) and severe COPD (FEV1 < 40% of predicted)- a lack of data in this patient population.
  • Pregnancy/ lactation- lack of data, seek specialist advice.
  • Patients with psychiatric co-morbidities
    • In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions have been reported. As with other hypnotics, daridorexant should be administered with caution in patients exhibiting symptoms of depression. There is limited data in patients with psychiatric co-morbidities.

Therefore, for patients under Kent and Medway partnership trust (KMPT) initiation should be within the KMPT Service. KMPT will have the responsibility to review at 3 months and 12 months. Ongoing prescribing in primary care can continue following initiation by a KMPT clinician.

Pack Price
30 tablet (3 x 10 tablets) £42.00
Pack Price
30 tablet (3 x 10 tablets) £42.00
Pack Price
30 tablet £3.96
Pack Price
30 tablet £10.89
Pack Price
30 tablet £10.89
Pack Price
30 tablet £10.89
Pack Price
30 tablet £10.89
Pack Price
30 tablet £10.89
Pack Price
30 tablet £10.99
Pack Price
100 ml £17.10
150 ml £25.65
Pack Price
60 tablet (2 x 30 tablets) £41.20
Pack Price
30 tablet £103.00

Used in paediatrics. The suppositories are only given when the oral route cannot be used

Pack Price
1 suppository
12 suppository