Podcast - Insomnia Management According to NICE: Sleep Like a Pro

This episode makes reference to guidelines produced by the "National Institute for Health and Care Excellence" in the UK, also referred to as "NICE". Please note that the content on this channel reflects my professional interpretation/summary of the guidance and that I am in no way affiliated with, employed by or funded/sponsored by NICE.

My name is Fernando Florido and I am a General Practitioner in the United Kingdom. In this episode I will go through a number of NICE products on insomnia, including guidance on the medical technology sleepio, and the prescribing of z-drugs, daridodexant and melatonin.

I will summarise the guidance from a Primary Care perspective only.

I am not giving medical advice; this video is intended for health care professionals; it is only my interpretation of the guidelines and you must use your clinical judgement.  

There is a podcast version of this and other videos that you can access here:

Primary Care guidelines podcast:  

·      Redcircle: https://redcircle.com/shows/primary-care-guidelines

·      Spotify: https://open.spotify.com/show/5BmqS0Ol16oQ7Kr1WYzupK

·      Apple podcasts: https://podcasts.apple.com/gb/podcast/primary-care-guidelines/id1608821148

There is a YouTube version of this and other videos that you can access here:  

The Practical GP YouTube Channel: 

https://youtube.com/@practicalgp?si=ecJGF5QCuMLQ6hrk

The Medical technologies guidance [MTG70] on “Sleepio to treat insomnia and insomnia symptoms” can be found here:

·      https://www.nice.org.uk/guidance/mtg70

The Technology appraisal guidance [TA77] “Guidance on the use of zaleplon, zolpidem and zopiclone for the short-term management of insomnia” can be found here:

·      https://www.nice.org.uk/guidance/ta77

The Technology appraisal guidance [TA922] “Daridorexant for treating long-term insomnia” can be found here:

·      https://www.nice.org.uk/guidance/ta922

The Evidence summary [ES38] “Melatonin for treating sleep disorders in adults who are blind” can be found here:

·      https://www.nice.org.uk/advice/es38/chapter/Product-overview

Thumbnail photo: from Freepik: https://www.freepik.com/

·      Image by Freepik

·      Image by a href="https://www.freepik.com/free-photo/flat-lay-woman-laying-bed_28694061.htm#query=insomnia&position=21&from_view=search&track=sph&uuid=65539da6-4c29-453b-9d22-c39df5176601"Freepik/a

Intro / outro music: Track: Halfway Through — Broke In Summer [Audio Library Release]   

Music provided by Audio Library Plus   

Watch: https://youtu.be/aBGk6aJM3IU  

Free Download / Stream: https://alplus.io/halfway-through  

Transcript

Hello and welcome, I am Fernando, a GP in the UK. Today, we will go through a number of NICE publications on insomnia, including guidance on digital cognitive behavioural therapy for insomnia (CBT-I), and the prescribing of hypnotics, daridodexant and melatonin, all of them from a Primary Care perspective.

By the way, make sure that you stay for the entire episode because, at the end, I will go through some audit ideas backed by NICE which you could use as a Quality Improvement Project in your practice.

So, let’s jump into it.

Let’s talk a little about the condition first.

Insomnia is a disturbance of sleep characterised by difficulty in initiating and/or maintaining sleep. However, insomnia is highly subjective and although most healthy adults typically sleep between 7 and 9 hours per night, patterns vary between people, and in any given person there are also variations from night to night.

Estimates of the prevalence of insomnia vary and while up to 48% of people have reported sleeping issues, only 6% met the criteria for a diagnosis of insomnia. So, in general practice, differentiating between simple sleeping problems and significant insomnia is important before considering treatment.

The prevalence of insomnia is higher in women and increases with age and, although the majority do not seek medical advice, the treatment depends on the duration and nature of the symptoms. Appropriate management of co-morbidities may help and sleep hygiene advice is fundamental, for example, avoiding stimulants and maintaining regular sleeping hours with a suitable environment for sleep. Other non-pharmacological interventions, for example, cognitive behavioural therapies, are also effective.

Insomnia can have a number of different causes: primary insomnia can be differentiated from insomnia associated with factors such as personal circumstances, physical or psychiatric co-morbidities, concomitant drug treatments or substance abuse. Epidemiology surveys have shown that over half of people with sleep problems have either a mental or a physical health disorder.

And in this video, we will not be talking about specific issues caused by physical conditions such as sleep apnoea or narcolepsy or sleep disturbances associated to severe mental illness.

For the management, it is crucial to differentiate between short-term insomnia and long-term insomnia.

For short-term insomnia, sleep hygiene advice is offered. After this, medicines such as zopiclone, zolpidem and melatonin can be used for a short time, that is, less than 4 weeks or less than 13 weeks for melatonin. In addition, up to 40% of people with insomnia self-medicate with over-the-counter drugs, for example, sedative antihistamines.

However, long-term insomnia, also known as chronic insomnia, is different and it’s defined as dissatisfaction with quantity or quality of sleep for 3 nights or more per week for at least 3 months with an effect on daytime functioning. Therefore, long-term insomnia has both night-time and daytime symptoms. Furthermore, once insomnia has lasted for more than 6 months, it may last for years and be difficult to resolve.

For long term insomnia, sleep hygiene advice is given first and then, CBT-I is the recommended first-line treatment. But there are access difficulties to CBT-I across the country and in many areas access is poor. And this is a real pity because CBT-I has a 70% to 80% response rate and roughly 50% experience long-term remission.

NICE has published 17 products on insomnia but the majority are for sleep apnoea and narcolepsy. Only 4 would be relevant for this video and these are:

·      The Medical Technology Sleepio

·      Advice on hypnotics like benzodiazepines and Z-drugs such as zolpidem and zopiclone

·      Recommendations on Daridorexant

·      And finally, we will also briefly touch on melatonin

Sleepio is a digital self-help programme that includes CBT‑I and that reduces symptoms compared with sleep hygiene and sleeping tablets. The gold standard treatment for insomnia is face-to-face CBT-I, but its availability is very limited and therefore Sleepio is recommended as an alternative to sleeping tablets. Unfortunately, Sleepio is not available on the NHS in all regions of the UK either.

Let’s have a look at the recommendations on hypnotics like benzodiazepines and Z-drugs such as zolpidem and zopiclone. They can be considered after sleep hygiene but for a short time only and bearing in mind that they do not treat any underlying cause.

A number of hypnotic agents are licensed for the treatment of insomnia, including benzodiazepines and Z-drugs.

Benzodiazepines enhance the effects of GABA, which is the major inhibitory neurotransmitter in the central nervous system. Examples licensed for insomnia are, amongst others, nitrazepam, temazepam and lorazepam.

The effects of benzodiazepines are dependent upon the dose administered and the pharmacokinetic profile. The BNF refers to temazepam and lorazepam, as having a shorter duration of action. Benzodiazepines with a longer half-life like diazepam and nitrazepam tend to have prolonged effects the next day.

The main concern with benzodiazepines is that many people develop tolerance to their effects, gain little benefit from chronic use, become both physically and psychologically dependent on them, and suffer withdrawal symptoms when stopping them. 'Rebound insomnia' also occurs and is characterised by worsening insomnia symptoms.

The use of benzodiazepines for the treatment of insomnia should be restricted to severe insomnia and treatment should not be continued beyond 4 weeks.

Zolpidem and zopiclone (the Z-drugs) are non-benzodiazepine hypnotics. Although the Z-drugs differ structurally from the benzodiazepines, they are also agonists of the GABA receptor complex and therefore enhance GABA-mediated neuronal inhibition.

Zolpidem has a half-life of 2.5 hours and Zopiclone of between 3.5 and 6.5 hours. They are licensed for "the short-term treatment of insomnia in situations where the insomnia is debilitating or is causing severe distress for the patient". The duration of treatment is a maximum of 4 weeks, including tapering off where appropriate.

Although the Z-drugs were developed to overcome the disadvantages of benzodiazepines, the sedative effects of the Z-drugs may also persist into the next day and they can cause tolerance, dependence and withdrawal symptoms.

It may be worth mentioning that, a review of the trial evidence comparing the Z-drugs with benzodiazepines licensed for insomnia showed, in summary, that there were no clinically useful differences between the drugs.

Because of the lack of evidence to distinguish between zolpidem and zopiclone, the drug with the lowest purchase cost should be prescribed and switching from one to another should only occur if a patient experiences adverse effects considered to be directly related to a specific agent.

Patients who have not responded to one of these hypnotic drugs should not be prescribed any of the others.

So, we have now seen that short term insomnia can be treated with sleep hygiene and short-term use of hypnotics and long-term insomnia with sleep hygiene and either face to face CBT-I or digital CBT-I like Sleepio.

But what does NICE recommend for long term insomnia if CBT-I or Sleepio have not worked or are not available?

And here is where we find the latest NICE guidance on this issue, published in October 2023. It refers to a new type of drug, Daridorexant.

And NICE says that Daridorexant is both clinically and cost effective and it is recommended for insomnia lasting for 3 nights or more per week for at least 3 months, with affected daytime functioning but only if:

·      cognitive behavioural therapy for insomnia (CBT-I) is ineffective or

·      it is not available or is unsuitable.

What is daridorexant? Well, Daridorexant is now available on the BNF and unlike benzodiazepines and Z-drugs, which work by increasing sedation, daridorexant is a new type of drug, an orexin antagonist, which works in a different way. It inhibits arousal mechanisms. To understand this, we need to know that orexins are neuropeptides produced by the hypothalamus which promote a state of wakefulness. Therefore, daridorexant, by blocking the orexin receptors, reduces wakefulness and helps sleep.

Because of the different mechanism of action, if necessary, daridorexant could be used at the same time as other medicines or non-medicine treatments available for insomnia.

And the good news is that, in clinical studies, there has been no evidence of abuse or withdrawal symptoms indicative of physical dependence.

NICE recommends that the length of treatment should be as short as possible and the treatment should be reviewed within 3 months of starting and at regular intervals thereafter. But it can be used as maintenance treatment for managing longer-term symptoms if necessary.

Now let’s touch on the prescribing of Melatonin for insomnia.

Melatonin is a hormone that occurs naturally in the body. It is involved in regulating sleep and circadian rhythms and it can be given as an oral medication to treat sleeping problems.

There is little NICE guidance on the use of melatonin. There is only an evidence summary on the use of melatonin for treating sleep disorders in adults who are blind, and, because of insufficient evidence, NICE was unable to determine its clinical effectiveness and safety.

The BNF states that melatonin is indicated as:

·      Short-term treatment for Insomnia in adults over 55 for up to 13 weeks

·      Short-term treatment for Jet lag in adults for up to 5 days, and

·      Treatment for Insomnia in patients with learning disabilities and challenging behaviour, although this use is unlicensed and it needs to be initiated under specialist supervision

Cautions for melatonin include autoimmune disease, as exacerbations have been reported occasionally, and susceptibility to seizures, as there is a risk of increased seizure frequency

Reported side effects are, amongst others, arthralgia, increased risk of infection, drowsiness, headaches, and pain

Now, as promised let’s have a look at audit ideas on the use of hypnotics (including Z-drugs) suggested by NICE and that you could use for a Quality Improvement Project in your Practice.

The objectives for the audit would be to assess the appropriateness of use of zolpidem and zopiclone.

The patients to be included in the audit could be, for example, all those for whom zolpidem and zopiclone are prescribed for a suitable period of time, for example, 3–6 months.

Possible audit criteria could be the following four:

Criterion 1- Non-pharmacological measures are considered before prescribing:

·      The standard would be 100% of all patients without exception

Criterion 2- When prescribed, hypnotic drug therapy is prescribed for a short period of time only, in strict accordance with the licensed indications:

·      The standard would also be 100% of all patients without exception

Criterion 3- When prescribed, the hypnotic drug with the lowest cost is chosen:

·      The standard would be 100% of all patients with the exception of those who have developed side effects with a cheaper first line agent

Criterion 4- A patient is switched from one hypnotic drug to another:

·     As switching is not recommended, the standard would be 0% of all patients with the exception of those who have developed adverse effects considered to be directly related to a specific agent

Once compliance has been calculated, the Practice can identify whether clinical management can be improved, agree on a plan and repeat the measurement after a period of time to close the audit cycle and to confirm that the desired improvement has been achieved.

And there you have it, a simple project to fulfil your QIP requirements for appraisal.

We have come to the end of this episode. Remember that this is not medical advice and it is only my summary and my interpretation of the guideline. You must always use your clinical judgement.

Thank you for listening and goodbye.