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Mental health

Insomnia

Last revised in June 2026

Insomnia is difficulty in getting to sleep, difficulty staying asleep, early wakening, or non-restorative sleep

Insomnia: Summary

  • Insomnia is defined as a persistent difficulty with getting to sleep, maintaining sleep, or quality of sleep, which occurs despite adequate opportunity and circumstances for sleep, and results in impaired daytime functioning.
    • Daytime symptoms typically include fatigue, depressed mood, irritability, general malaise, and cognitive impairment.
    • Sleep disturbance in the absence of daytime impairment is not considered to be insomnia disorder.
  • There is no standard definition of what constitutes normal sleep — the amount of sleep needed to ensure good health varies from person to person and with ageing.
  • Insomnia is categorized according to duration:
    • Short-term insomnia lasts less than 3 months.
    • Chronic insomnia occurs at least several days per week and lasts for 3 months or longer.
  • Short-term insomnia is common and can occur in association with stressful events or changes in sleeping patterns such as illness, financial difficulties, the birth of a child, or environmental disturbance.
  • Chronic insomnia commonly co-exists with other psychiatric and medical conditions (for example anxiety, depression, COPD, cardiovascular disease, neurological conditions, malignancy, diabetes mellitus, musculoskeletal conditions, and chronic pain) with bidirectional or interactive effects. 
    • Maladaptive behaviours and cognition are thought to be involved in the development of chronic insomnia.
  • Other sleep disorders (such as obstructive sleep apnoea, restless legs syndrome, and parasomnias) should be considered in the assessment of a person with suspected insomnia as there are high rates of comorbidity.
  • Assessment involves a thorough history and evaluation, which includes identifying contributory factors and physical and mental health comorbid conditions.
    • A sleep diary kept for 1-2 weeks can be helpful in identifying sleeping patterns and lifestyle factors that may exacerbate or maintain insomnia. 
  • Good sleep hygiene should be considered in all people with insomnia, and information offered. This aims to make people more aware of behavioural, environmental, and temporal factors that may be detrimental or beneficial to sleep.
  • Hypnotic medication should be avoided if possible due to the potential for significant adverse effects.
    • Cognitive behavioural therapy for insomnia (CBTi) is recommended for the treatment of both short- and chronic insomnia in adults of all ages — unlike medication, benefits associated with CBTi persist after completion of treatment.
  • For short-term insomnia where daytime impairment is severe, causing significant distress, and:
    • Insomnia is likely to resolve soon (for example due to a short-term stressor), a short course (3-7 days) of a non-benzodiazepine hypnotic medication (z-drugs) may be considered. These should be avoided, if possible, in older people.
    • Insomnia is not likely to resolve soon, CBTi should be offered as the first-line treatment. Sleepio is a digitally delivered treatment, based on CBTi, recommended by NICE. Adjunctive treatment with a short-term hypnotic medication (a z-drug or prolonged released melatonin if over 55 years of age) may be appropriate.
  • For chronic insomnia:
    • CBTi should be offered as the first-line treatment in adults of any age. Sleepio can also be offered. 
    • Pharmacological therapy should be avoided in the long-term management of insomnia.
  • Referral to a sleep clinic or neurology may be required if another sleep disorder is suspected, there is doubt regarding the diagnosis, or chronic insomnia has not responded to management in primary care.

Have I got the right topic?

From age 18 years onwards.

This CKS topic covers the management of insomnia in adults in primary care.

This CKS topic does not cover the management of underlying causes of insomnia or the management of sleep-related breathing disorders (such as sleep apnoea), circadian rhythm disorders (such as advanced and delayed sleep phase disorders, shift work, and jet lag), or sleep-related movement disorders (such as restless legs syndrome and periodic limb movement disorder). This CKS topic does not cover sleep disorders in long-term care settings.

There are separate CKS topics on Benzodiazepine and z-drug withdrawal, Depression, Generalized anxiety disorder, Post-traumatic stress disorder, Obstructive sleep apnoea syndrome, Dementia, Attention deficit hyperactivity disorder, Autism in children, Autism in adults , Menopause, Tiredness/fatigue in adults , Tinnitus, Learning disabilities, Cerebral palsy, and Sleep disorders - shift work and jet lag.

The target audience for this CKS topic is healthcare professionals working within the NHS in the UK, and providing first contact or primary healthcare.

How up-to-date is this topic?

Changes

June 2026 — minor update. The following changes have been made: all usage of the term 'long-term insomnia' has been corrected to 'chronic insomnia'; wording has been changed to clarify the use of hypnotic drugs in the management of chronic insomnia; and reasoning as to why over-the-counter medication treatments for insomnia should not be recommended has been added to the relevant basis-for-recommendation sections.

Previous changes

October 2025 — minor update. Added information on dosing for Lunivia®in line with an update to the BNF. 

May 2025 — minor update. Added information about SNRIs causing insomnia and additional information regarding ADHD, autism spectrum disorder, menopausal symptoms and tinnitus when assessing a person with insomnia. Further links to other CKS topics also added. 

April 2025 — minor update. Update to the text on dosing for the elderly for Lunivia®.

March 2025 — minor update. Added information on dosing for Lunivia®. 

February 2025 — minor update. Added information on the availability of a new drug option for the treatment of insomnia, Lunivia®. 

June 2024 — minor update. Further clarification on wording regarding the use of Sleepio as recommended by NICE. 

April 2024 — reviewed.  A literature search was conducted in February - March 2024 to identify evidence-based guidelines, UK policy, systematic reviews, and key randomized controlled trials published since the last revision of the topic. Recommendations from the National Institute for Health and Care Excellence (NICE) on the use of Sleepio and daridorexant in the management of insomnia have been incorporated into the topic, along with links for NHS users of Sleepio. Minor changes to the structure of the topic have been made. 

February 2024 — minor update. Added prescribing information for daridorexant in line with the NICE technology appraisal Daridorexant for treating long-term insomnia.

January 2024 — minor update. A recommendation to consider offering daridorexant for people with chronic insomnia has been added in line with the NICE technology appraisal Daridorexant for treating long-term insomnia.

May 2022 — minor update. Removed reference to NICE key therapeutic topic as this has been withdrawn. Removed related adverse effects and updated these in line with the manufacturer's summary of product characteristics. 

February 2022 — minor update. Link to Mental Health Foundation has been updated.

March 2021 — minor update. Information on the risks associated with melatonin has been clarified to align with the updated NICE Key therapeutic topic on Insomnia.

January 2020 — reviewed. A literature search was conducted in January 2020 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of this topic.

April 2015 — minor update. Update to the text to reflect a new law on drugs and impaired driving Department for Transport, 2014.

November 2014 — minor update. Update to the text to reflect recent MHRA advice regarding zolpidem and next day drowsiness, which may affect driving ability MHRA, 2014.

March 2014 — reviewed. Literature searches were conducted in January 2014 to identify evidence-based guidelines, UK policy, systematic reviews, and key RCTs published since the last revision of this topic. No significant changes have been made to the recommendations in this topic. A prescribing information section has been added.

July 2013 — minor update. Links to the DVLA website have been updated.

February 2013 — minor update. The 2013 QIPP options for local implementation have been added to this topic.

October 2012 — minor update. The 2012 QIPP options for local implementation have been added to this topic.

June 2011 — minor update. The 2010/2011 QIPP options for local implementation have been added to this topic. 

November to December 2010 — minor update. Modified-release melatonin is now licensed for up to 26 weeks of treatment in elderly people with primary insomnia. Issued in February 2010.

April to July 2009 — converted from CKS guidance to CKS topic structure. The evidence-base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence. Modified-release melatonin is now licensed for the management of primary insomnia in older adults, the evidence for its efficacy has been reviewed in detail, and recommendations for its use have been added. Recommendations on the management of sleep disturbances associated with shift work and jet lag have been removed from this topic and have been included in a separate CKS topic on Sleep disorders - shift work and jet lag.

September 2008 — minor correction to the Changes section. 

January to March 2006 — reviewed. Validated in June 2006 and issued in July 2006.

November 2005 — minor technical update. 

July 2005 — minor correction to references. 

March 2003 — reviewed. Validated in June 2003 and issued in July 2003.

February 1999 — written, replacing CKS guidance on Sleep disturbances, Transient insomnia, and Persistent insomnia. Validated in April 1999 and issued in August 1999.

Update

New evidence

Evidence-based guidelines

No new evidence-based guidelines since 1 March 2024.

HTAs (Health Technology Assessments)

No new HTAs since 1 March 2024.

Economic appraisals

No new economic appraisals relevant to England since 1 March 2024.

Systematic reviews and meta-analyses

No new systematic reviews published since 1 March 2024.

Primary evidence

No new primary evidence which reaches the CKS threshold for inclusion published since 1 March 2024.

New policies

No new national policies or guidelines since 1 March 2024.

New safety alerts

No new safety alerts since 1 March 2024.

Changes in product availability

  • New product eszopiclone (Lunivia®) is an additonal treatment option for adults for the treatment of insomnia, usually for short-term duration. See more here.

Goals and outcome measures

Goals

To support primary healthcare professionals to:

  • Make a diagnosis of insomnia and rule out other sleeping disorders.
  • Identify and address any underlying causes of insomnia or associated comorbidities.
  • Address behavioural issues that might be causing or exacerbating insomnia.
  • Refer for cognitive behavioural treatment as appropriate.
  • Reduce the use of hypnotic drugs.

Outcome measures

No outcome measures were found during the review of this topic.

Audit criteria

No audit criteria were found during the review of this topic.

QOF indicators

No QOF indicators were found during the review of this topic.

QIPP - Options for local implementation

No QIPP indicators were found during the review of this topic.

NICE quality standards

No NICE quality standards were found during the review of this topic.

Background information

What is it?

  • Insomnia is defined as a persistent difficulty with getting to sleep, maintaining sleep, or quality of sleep, which occurs despite adequate opportunity and circumstances for sleep, and results in impaired daytime functioning.
    • Daytime symptoms typically include fatigue, depressed mood, irritability, general malaise, and cognitive impairment.
    • Sleep disturbance in the absence of daytime impairment is not considered to be insomnia disorder.
  • Short-term insomnia is characterized by symptoms occurring for less than 3 months duration (typically a few days or weeks).
  • Chronic insomnia is characterized by Insomnia symptoms occurring on at least 3 nights per week for 3 months or more.

[Riemann, 2023; WHO, 2024]

What is considered to be normal sleep?

  • Sleep is an important factor in many processes including neural development, learning, memory, regulation of emotion, and cardiovascular and metabolic functioning.
  • There is no standard definition of normal sleep — the amount of sleep needed to ensure good health varies from person to person and with age.
    • It is reasonable to assume individuals are getting the right amount of sleep if they wake feeling well-rested and able to perform well during the day. 
    • With ageing the number of awakenings increases and total sleep time decreases. This may be due to changes that occur as part of the ageing process, but may also be due to comorbidity and polypharmacy, or lifestyle changes.
  • A number of organizations, such as the American Thoracic Society, the National Sleep Foundation, the American Academy of Sleep Medicine, and the Sleep Research Society recommend that the optimal sleep duration in adults is 7–9 hours.
    • Persistent insufficient sleep (usually considered to be 6 hours or less per 24 hours) has been associated with adverse outcomes including obesity, type 2 diabetes, hypertension, cardiovascular disease, depression, and all-cause mortality.
    • Long sleep duration (more than 9–10 hours per 24 hours) may be normal but has also been associated with adverse outcomes. However, long sleep duration may be a marker of ill-health and physical inactivity rather than a cause of ill-health.
  • The normal time taken to fall asleep (sleep-onset latency) is usually considered to be less than 20 minutes. The average mean sleep latency has been measured to be 11.7 minutes.

 [Hirshkowitz, 2015; Mukherjee, 2015; Watson, 2015; Chaput, 2018; Iskander, 2023]

What are the causes of insomnia?

  • Short-term insomnia — transient insomnia is common and typically lasts a few days or weeks. It can occur in association with:
    • Stressful events such as bereavement, illness, changes in employment, exams, pending deadlines, or financial difficulties.
    • Changes in sleeping patterns due to the birth of a child or environmental disturbance such as excess noise or light, or extremes of temperature.
  • Chronic insomnia — factors involved in the maintenance of insomnia are not fully understood but are thought to include maladaptive behaviours and cognitive processes. The persistence of the initial stressor may also contribute.
    • Chronic insomnia commonly co-exists with other conditions including:
      • Mental health conditions such as anxiety, depression, ADHD,  autism spectrum disorder, and bipolar disorder.
      • Substance misuse such as alcohol and illicit drugs.
      • Other medical disorders such as COPD, cardiovascular disease, neurological conditions (such as stroke, Parkinson's disease, epilepsy, migraine, and traumatic brain injury), malignancy, diabetes mellitus, tinnitus, musculoskeletal conditions, and chronic pain.
      • Other sleep disorders, such as obstructive sleep apnoea syndrome and restless legs syndrome.
    • Bidirectional or interactive effects often exist between chronic insomnia and co-morbid conditions (for example anxiety, depression, and substance abuse).
    • Menopause and ageing also predispose to insomnia.

[AMA, 2015; Wilson, 2019; Dopheide, 2020; Riemann, 2023; Yamamoto, 2023]

How common is it?

  • Estimates of the prevalence of insomnia vary widely from 5–50% depending on the definition used:
  • Prevalence of insomnia is 1.5–2 times higher in females than males [AMA, 2015; Matheson, 2017; Wilson, 2019]. Insomnia is reported in more than 25% of women during perimenopause [Baker, 2018; Yamamoto, 2023].
  • Insomnia can occur at any age, but increases with age and is most common in older adults, in whom it is more likely to be long-term [AMA, 2015; BMJ Best Practice, 2023].
  • Prevalence of insomnia is higher in people with comorbid conditions such as chronic obstructive pulmonary disease, heart failure, chronic pain, and mental health conditions (depression, anxiety, substance abuse, and post-traumatic stress disorder) [AMA, 2015].
    • Around half of all people with diagnosed insomnia have a comorbid psychiatric disorder [Wilson, 2019]. 
    • Up to 70% of those with major depressive disorder have insomnia, and there is at least twice the risk of developing depression and anxiety in those with pre-existing insomnia [Wilson, 2019].
  • There is high comorbidity with other sleep disorders, such as obstructive sleep apnoea (OSA), restless legs syndrome (RLS), and periodic limb movement disorder (PLMD) [Riemann, 2023].

What is the prognosis?

  • Short-term insomnia
    • Acute insomnia is very common and typically lasts a few days or weeks, resolving once the triggering factor is removed [BMJ Best Practice, 2023].
    • About one in five cases of short-term insomnia go on to become chronic [Dopheide, 2020].
  • Chronic insomnia
    • Chronic insomnia may persist for months or years [BMJ Best Practice, 2023].
    • A longitudinal study in a UK population (n=870 with insomnia) found that 69% of people reporting insomnia at baseline had insomnia at 12-month follow-up — persistence of insomnia was significantly associated with older age [Morphy, 2007]. 
    • A Canadian population-based longitudinal study (n=388 with insomnia) found that 74% of people had insomnia persisting for at least 1 year and 46% had insomnia persisting for 3 years — persistence of insomnia was more likely in those with severe symptoms at baseline, in women, and in older adults [Morin, 2009].
    • There is significant evidence of cognitive behavioural therapy for insomnia (CBTi) leading to improvement in insomnia symptoms, whether digitally or in person, and also evidence that this improvement (unlike pharmacological treatment) is sustained over time [Davidson, 2019; NICE, 2022; Riemann, 2023]. Evidence comparing digital vs face-to-face delivery is limited, but the availability of evidence-backed digital CBTi programmes such as Sleepio improves access to treatment.

What are the complications?

Insomnia is associated with:

  • Cognitive difficulties such as impaired memory, attention, and concentration.
  • Decreased quality of life and function including:
    • Impaired work performance and increased work absenteeism.
    • Increased risk of motor vehicle accidents and accidents in the workplace.
    • Increased risk of falls in older people.
  • Psychiatric complications including anxiety, depression, and substance misuse.
    • There is evidence that a history of persistent insomnia at least doubles the risk of developing depression, as well as being a significant predictor for onset of anxiety, alcohol abuse, and psychosis. 
    • Insomnia has been found to be associated with a higher risk for suicidal behaviour.
  • Medical complications.
    • Studies have shown associations between persistent insomnia and increased risk of obesity, hypertension, cardiovascular disease, and type 2 diabetes, in particular with objectively measured short sleep duration (less than 6 hours per 24 hour period).
  • A possible increase in all-cause mortality — findings from studies vary.

 [Baglioni, 2011; Mukherjee, 2015; Chaput, 2018; Ge, 2019; Hertenstein, 2019; Wilson, 2019; Yamamoto, 2023]

Diagnosis of insomnia

How do I diagnose insomnia?

  • Diagnose insomnia if (despite adequate time and opportunity to sleep) the person has persisting difficulty in getting to sleep, difficulty maintaining sleep, or non-restorative sleep that results in impaired daytime functioning or wellbeing.
    • Daytime symptoms may include fatigue, depressed mood or irritability, malaise, and cognitive impairment.
    • Sleep difficulties without daytime impairment do not meet the diagnostic criteria for insomnia.
  • Short-term insomnia can be diagnosed if symptoms have been present for less than 3 months.
  • Chronic insomnia can be diagnosed if symptoms occur on at least 3 nights per week for 3 months or more.

Basis for recommendation

This information is based largely on diagnostic criteria within the International Classification of Diseases 11th revision (ICD-11) from the World Health Organization [WHO, 2024], and also on recommendations in the European insomnia guideline: An update on the diagnosis and treatment of insomnia 2023 [Riemann, 2023].  

How should I assess a person with suspected insomnia?

Take a history and ask about:

  • Symptoms such as difficulty in getting to sleep, difficulty maintaining sleep, early waking, non-restorative sleep, and daytime impairment.
  • Duration and frequency of symptoms.
  • Impact of insomnia on quality of life, ability to drive, employment, relationships, and mood.
  • Sleep schedule including bedtimes, time taken to get to sleep, awakenings, and rise time.
  • Sleep environment.
  • Possible triggers such as stress, shift work, and jet lag.
  • Behaviours during sleep such as snoring, witnessed apnoea, restless legs, or sleepwalking, which may indicate an alternative cause. 
  • Past and current medical history including:
    • Previous sleep problems and treatment.
    • Comorbidities such as chronic pain, medical disorders (such as chronic obstructive pulmonary disease, heart failure, diabetes mellitus, neurological conditions, tinnitus, menopausal symptoms, or gastro-oesophageal reflux disease) and mental health conditions (such as anxiety, ADHD, PTSD, autism spectrum disorder, or depression).
  • Prescribed medication.
    • Consider as a cause or contributory factor.
    • Many medications include insomnia as a side effect (for example corticosteroids, selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and beta-blockers).
  • Substance use including caffeine, alcohol, nicotine, and illicit drugs.
    • Alcohol use may be a contributory cause, and may also be used as a maladaptive self-medication strategy, exacerbating the problem.

Carry out an examination where appropriate:

  • Screen for depression and anxiety using validated questionnaires such as the PHQ-9 and GAD-7. See the CKS topics Depression and Generalized anxiety disorder for more information.
  • Depending on the specific clinical situation, physical examination may help identify comorbid conditions.

Consider the need for investigations:

  • A sleep diary can help assess sleep difficulties and daytime impairment over time; it should be kept for 2 weeks and record:
    • The time of going to bed and getting up.
    • The time taken to get to sleep and the number and duration of episodes of waking through the night.
    • Episodes of daytime tiredness and naps.
    • Times of meals, alcohol consumption, caffeine consumption, and significant events during the day, such as exercise or stress.
    • Rating of sleep quality (ask the person to rate the quality of their sleep each night, from 1 to 5, where 1 is very poor and 5 is very good).
  • An example of a 2-week sleep diary is available from the American Academy of Sleep Medicine, or a more detailed example is available from the Sleep Foundation.
  • Consider the use of a recognised tool to grade severity as a baseline, for example:
    • The Insomnia Severity Index, which scores severity between 0 and 28.
      • 8 - 10 suggests subclinical insomnia, 15 - 21 suggests moderate insomnia, and 22 - 28 severe insomnia.
      • A change of 8.4 or more is indicative of moderate improvement when using to evaluate efficacy of treatment.
    • The Sleep Condition Indicator.
  • Depending on the clinical situation, other investigations may be appropriate for example where a comorbid condition (such as hyperthyroidism, respiratory or cardiovascular disease) or another sleep disorder is suspected.

Basis for recommendation

These recommendations are based on the European insomnia guideline: An update on the diagnosis and treatment of insomnia 2023 [Riemann, 2023], the British Association for Psychopharmacology 2019 consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: An update [Wilson, 2019], and the 2015 Alberta clinical practice guideline, Assessment to management of adult insomnia [AMA, 2015].

What else might it be?

Consider other sleep disorders such as:

  • Obstructive sleep apnoea — for more information see the CKS topic on Obstructive sleep apnoea syndrome. 
  • Circadian rhythm disorders — for more information see the CKS topic on Sleep disorders - shift work and jet lag. 
  • Restless legs syndrome — for more information see the CKS topic on Restless legs syndrome. 
  • Periodic limb movement disorder (PLMD) — rhythmic movements of the limbs during sleep which may disturb sleep.
  • Narcolepsy — may present with falling asleep in the daytime without warning and collapse or muscle weakness triggered by emotion.
  • Parasomnias — may present with unusual or unpleasant experiences or behaviours associated with sleep that are troublesome or dangerous.

Basis for recommendation

This information is based on the European insomnia guideline: An update on the diagnosis and treatment of insomnia 2023 [Riemann, 2023], the British Association for Psychopharmacology Consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update [Wilson, 2019], and the BMJ Best Practice guide, Insomnia [BMJ Best Practice, 2023].

Management

Scenario: Managing insomnia

From age 18 years onwards.

How should I manage a person with short-term insomnia (less than 3 months duration)?

  • Consider the need for referral to a sleep clinic or neurology if symptoms of another sleep disorder are present.
  • Address any circumstances/stressors associated with onset of insomnia.
    • Ensure comorbidities (for example, anxiety or depression) are optimally managed.
  • Offer advice on sleep hygiene. 
  • Advise the person not to drive if they feel sleepy.
    • The Driver and Vehicle Licensing Agency (DVLA) must be informed if excessive sleepiness is having, or is likely to have, an adverse effect on driving such as:
      • Obstructive sleep apnoea syndrome (any severity).
      • Primary/central hypersomnias (such as narcolepsy).
      • Any other conditions or medication that may cause excessive sleepiness.
    • For more detailed guidance, see the DVLA guide, Assessing fitness to drive: a guide for medical professionals, and direct the person to the DVLA guide Tiredness can kill .
  • If sleep hygiene measures fail, daytime impairment is severe causing significant distress, and insomnia is likely to resolve soon (for example due to a short-term stressor):
    • Consider a short course (3-7 days) of a non-benzodiazepine hypnotic medication (z-drug).
      • Do not prescribe hypnotics routinely — use only for short courses if acutely distressed.
      • Do not prescribe hypnotics to older people or women who are pregnant or breastfeeding.
      • For more information, see the section on Prescribing. 
  • If sleep hygiene measures fail, daytime impairment is severe (for example, it is affecting alertness or work/social functioning) causing significant distress, and insomnia is not likely to resolve soon:
    • Offer cognitive behavioural therapy for insomnia (CBTi).
      • CBTi typically includes behavioural interventions (such as stimulus control and sleep restriction). Cognitive therapy and relaxation training can be provided face-to-face or digitally.
      • Sleepio is a digital CBTi-based treatment recommended by the National Institute for Health and Care Excellence (NICE). See the NICE publication, Sleepio to treat insomnia and insomnia symptoms for more information.
    • Consider the need for adjunctive treatment with a short-term hypnotic medication (a z-drug or prolonged released melatonin if over 55 years of age).
      • Do not prescribe hypnotics routinely — use only for short courses if acutely distressed.
      • Do not prescribe hypnotics to older people or women who are pregnant or breastfeeding.
      • For more information, see the section on Prescribing. 
  • If a hypnotic is prescribed:
    • Consider the duration of action (short-acting is usually most appropriate), adverse effects, interactions, and potential for dependency and abuse.
    • Use the lowest effective dose for the shortest period possible — do not continue treatment for longer than 2 weeks (preferably less than 1 week).
    • Inform the person that further prescriptions for hypnotics will not usually be given, ensure that the reasons for this are understood, and document this in the person's notes.
    • Do not issue further prescriptions without seeing the person again.
    • If there has been no response to the first hypnotic, do not prescribe another.
  • Signpost to sources of information on insomnia such as:
  • Arrange follow up for review (for example 2–4 weeks, dependant on the clinical situation).
  • Do not recommend over-the-counter treatments for insomnia.

Basis for recommendation

These recommendations are based on the British Association for Psychopharmacology consensus statement Evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update [Wilson, 2019], clinical guidance Assessment to management of adult insomnia [AMA, 2015], the European insomnia guideline: an update on the diagnosis and treatment of insomnia 2023 [Riemann, 2023], the BMJ Best Practice guide Insomnia [BMJ Best Practice, 2023], the National Institute for Health and Care Excellence (NICE) medical technologies guidance Sleepio to treat insomnia and insomnia symptoms [NICE, 2022], the British National Formulary [BNF, 2024], and expert opinion in review articles, Management of insomnia in primary care [Ng, 2021], and Insomnia in primary care: considerations for screening, assessment and management [Yamamoto, 2023]. The recommendations on driving are based on the Driver and Vehicle Licensing Agency (DVLA) guidance Assessing fitness to drive: a guide for medical professionals [DVLA, 2024].

Over-the-counter treatments for insomnia

The recommendation not to recommend over-the-counter treatments for insomnia is due to the lack of evidence concerning the effectiveness of these medications, such as antihistaminics, in the treatment of insomnia. In addition, these medications increase possible risks due to their adverse effects, for example, an increased risk of dangerous confusion and falls in older people with the use of sedating antihistamines [Riemann, 2023].

How should I manage someone with chronic insomnia (more than 3 months duration)?

  • Consider the need for referral to a sleep clinic or neurology if symptoms of another sleep disorder are present.
  • Address any triggers or factors associated with the maintenance of insomnia (for example, illness or other stressors).
    • Ensure comorbidities (such as anxiety and depression) are optimally managed.
  • Offer advice on sleep hygiene. 
  • Advise the person not to drive if they feel sleepy.
    • The DVLA must be informed if excessive sleepiness is having, or is likely to have, an adverse effect on driving, including:
      • Obstructive sleep apnoea syndrome (any severity).
      • Primary/central hypersomnias (such as narcolepsy).
      • Any other conditions or medication that may cause excessive sleepiness.
    • For more detailed guidance, see the DVLA guide, Assessing fitness to drive: a guide for medical professionals, and direct the person to the DVLA guide Tiredness can kill.
  • Offer cognitive behavioural therapy for insomnia (CBTi) as the first-line treatment for chronic insomnia in adults of any age.
    • CBTi typically includes behavioural interventions (such as stimulus control and sleep restriction), cognitive therapy, and relaxation training. It can be provided face-to-face or digitally.
    • Sleepio is a digital CBTi-based treatment recommended by the National Institute for Health and Care Excellence (NICE). 
  • Use of benzodiazepines and z-drugs should be avoided in the long-term management of insomnia; however:
    • For some people with severe symptoms or an acute exacerbation, a short course of a benzodiazepine or a z-drug (preferably less than 1 week) may be considered as a temporary adjunct to behavioural and cognitive treatment.
  • For adults with chronic insomnia whose daytime functioning is considerably affected, consider offering daridorexant, if CBTi has been tried but not worked, or is unavailable or unsuitable. 
    • The length of treatment should be as short as possible. 
    • Treatment 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.
  • For people over 55 years of age with persistent insomnia, treatment with a prolonged-release melatonin may be considered.
    • The recommended duration of treatment is a maximum of 13 weeks.
  • Signpost to sources of information on insomnia such as:
  • Arrange follow up for review (2–4 weeks, dependant on the clinical situation).
  • Do not recommend over-the-counter treatments for insomnia.

Basis for recommendation

These recommendations are based on the European insomnia guideline: an update on the diagnosis and treatment of insomnia 2023 [Riemann, 2023], the British Association for Psychopharmacology consensus statement Evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update [Wilson, 2019], clinical guidance Assessment to management of adult insomnia [AMA, 2015], the BMJ Best Practice guide Insomnia [BMJ Best Practice, 2023], the National Institute for Health and Care Excellence (NICE) medical technologies guidance Sleepio to treat insomnia and insomnia symptoms [NICE, 2022], the NICE technology appraisal guidance Daridorexant for treating long-term insomnia [NICE, 2023a], the NICE guidance Suspected neurological conditions: recognition and referral [NICE, 2023b], the British National Formulary [BNF, 2024], and expert opinion in review articles, Management of insomnia in primary care [Ng, 2021], and Insomnia in primary care: considerations for screening, assessment and management [Yamamoto, 2023]. The recommendations on driving are based on the Driver and Vehicle Licensing Agency (DVLA) guidance Assessing fitness to drive: a guide for medical professionals [DVLA, 2024].

What advice should I give regarding good sleep hygiene?

Sleep hygiene aims to increase awareness of behavioural, environmental, and temporal factors that may be detrimental or beneficial to sleep. In chronic insomnia, psychoeducation including sleep hygiene is not recommended as a standalone management as it is more effective when delivered in the broader context of cognitive behavioural therapy for insomnia (CBTi). However, information about the principles of sleep hygiene may be useful in acute insomnia, to help prevent the development of maladaptive coping strategies, and may be helpful in those who cannot access, or do not want, CBTi.

  • Advise the person on:
    • Normal sleep and changes in sleep patterns with age.
    • Sleep environment.
      • A comfortable sleeping environment should be maintained: not too hot, cold, noisy, or bright.
      • The bedroom should only be used for sleep and intimacy.
      • Checking or watching the clock throughout the night should be avoided.
      • Bright light (including all technology) should be minimized. ‘Blue light’ displays on electronic devices and televisions suppress melatonin production — avoid using devices for at least an hour before bed.
    • Regular sleep schedules including:
      • Going to bed when sleepy — avoid going to bed too early.
      • Waking up and getting out of bed at the same time every morning including weekends and after a poor night's sleep — increase exposure to bright light in the morning.
      • Avoiding napping during the day.
      • Relaxation before going to bed (for example reading a book, having a bath, or listening to music ).
    • Limiting/avoidance of caffeine, nicotine, and alcohol.
      • Caffeine should be avoided after midday and nicotine, alcohol, and large meals within 2 hours of bedtime.
      • Alcohol intake is a common maladaptive self-treatment strategy for insomnia, which can contribute to poor sleep-maintenance.
    • Exercise.
      • Vigorous exercise should be avoided within an hour of bedtime, but is beneficial earlier in the day.
    • Sources of information about good sleep habits, such as:

Basis for recommendation

These recommendations are based on the British Association for Psychopharmacology consensus statement Evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update [Wilson, 2019], clinical guidance Assessment to management of adult insomnia [AMA, 2015], the European insomnia guideline: an update on the diagnosis and treatment of insomnia 2023 [Riemann, 2023], the BMJ Best Practice guide Insomnia [BMJ Best Practice, 2023],  a systematic review and meta-analysis Effects of evening exercise on sleep in healthy participants [Stutz, 2019], and expert opinion in review articles, Management of insomnia in primary care [Ng, 2021], The '5 principles' of good sleep health [Espie, 2022], Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy [Dopheide, 2020], and A review of the current state of research on artificial blue light safety as it applies to digital devices [Wong, 2022].

When should I refer to secondary care?

  • Refer the person to a sleep clinic, or specialist with expertise in sleep medicine or neurology, if:
  • Seek specialist advice/consider referral to secondary care if:
    • Treatment in primary care has failed.
    • Insomnia occurs in a person from an occupational at-risk group, for example, professional drivers.
  • Do not routinely refer adults with insomnia, jerks on falling asleep, or isolated brief episodes of sleep paralysis.
  • Seek specialist advice (from a psychiatrist with expertise in prescribing during pregnancy or an obstetrician) if considering pharmacological treatment for insomnia in pregnancy.

Basis for recommendation

The recommendations on when to refer a person with insomnia to secondary care are based on the clinical guidelines Assessment to management of adult insomnia [AMA, 2015], the National Institute for Health and Care Excellence (NICE) guidelines Suspected neurological conditions: recognition and referral [NICE, 2023b] and Obstructive sleep apnoea/hypopnoea syndrome and obesity hypoventilation syndrome in over 16s [NICE, 2021], the BMJ Best Practice guide Insomnia [BMJ Best Practice, 2023], and expert opinion in review articles Management of insomnia in primary care [Ng, 2021], and Insomnia in primary care: considerations for screening assessment, and management [Yamamoto, 2023]. 

Prescribing information

Important aspects of prescribing information relevant to primary healthcare are covered in this section specifically for the drugs recommended in this CKS topic. For further information on contraindications, cautions, drug interactions, and adverse effects, see the electronic Medicines Compendium (eMC), or the British National Formulary (BNF) .

Z-drugs

Dose

Z-drugs licensed for the short-term management of insomnia include:

  • Zopiclone
    • In adults — 7.5 mg once daily at bedtime.
    • In the elderly (avoid if possible due to increased risk of adverse effects) — if essential, use a lower dose; initially 3.75 mg once daily at bedtime. 
    • DO NOT re-administer during the same night.
  • Zolpidem
    • In adults — 10 mg once daily at bedtime; for debilitated patients, use elderly dose.
    • In the elderly (avoid if possible due to increased risk of adverse effects) — if essential, use a lower dose; 5 mg maximum once daily at bedtime.
    • DO NOT re-administer during the same night.
  • Eszopiclone
    • In adults — starting dose is 1mg once daily at bedtime. This can be increased to 2mg or (a maximum dose) of 3mg, if clinically indicated. 
    • In the elderly (avoid if possible due to increased risk of adverse effects) — the recommended dose for elderly patients is 1mg immediately before bedtime. The dose may be increased to 2mg if clinically indicated. 
    • DO NOT re-administer during the same night.
    • The usual maximum total treatment duration is 4 weeks. 

[Riemann, 2023; BNF, 2024; EMC, 2021; EMC, 2024a; EMC, 2025]

Contraindications and cautions

  • Do not prescribe z-drugs to people with:
    • Marked neuromuscular respiratory weakness.
    • Respiratory failure.
    • Myasthenia gravis.
    • Severe obstructive sleep apnoea.
    • Severe hepatic impairment.
    • Patients who have previously experienced complex sleep behaviours after taking zopiclone.
  • Prescribe z-drugs with caution to:
    • People with chronic pulmonary insufficiency — increased risk of respiratory depression.
    • The elderly — avoid if possible due to increased risk of adverse effects including falls and fractures.
    • People with a history of drug or alcohol abuse — manufacturer recommends extreme caution.
    • People with muscle weakness.
    • People with psychiatric illness including depression — possible increased risk of suicidal ideation or attempts.
    • People with hepatic and renal impairment — reduce dose, avoid if severe.
    • People who drive, work at heights or operate machinery, as drowsiness may persist the next day — advise patients to leave at least 8 hours between taking zolpidem and performing skilled tasks.
  • Advise that effects of alcohol may be enhanced when taken with z-drugs.
  • Z-drugs should be prescribed for short periods of time only, as the risk of dependence increases with dose and duration of treatment. Treatment should be as short as possible and should not exceed 4 weeks, including any period of tapering off. Withdrawal effects are unlikely when the duration of treatment is limited to 4 weeks.

[MHRA, 2014; Riemann, 2023; BNF, 2024; EMC, 2021; EMC, 2024a] 

Adverse effects

The adverse effects of Z-drugs include:

  • Gastrointestinal effects such as a bitter taste, dry mouth, abdominal pain, nausea, vomiting, and diarrhoea.
  • Psychiatric effects such as nightmares, agitation, hallucination, impaired cognition and concentration, depression, suicidal ideation and attempt, anxiety, psychosis and behavioural abnormalities, restlessness, irritability, aggression, delusions, anger, and inappropriate behaviour.
  • Neurological effects such as confusion, residual drowsiness, dizziness, hallucination, headache, speech disorder, ataxia, anterograde amnesia, muscle weakness, and decreased level of consciousness.
  • Respiratory depression (very rare).
  • Diplopia.
  • Gait disturbance and falls (particularly in the elderly).
  • Drowsiness may persist the following day and affect the performance of skilled tasks such as driving.
    • The Medicines and Healthcare Products Regulatory Agency (MHRA) advises that people who take zolpidem should:
      • Only take 10 mg of zolpidem at bedtime and not take it again the same night (people with liver impairment and the elderly should take no more than 5 mg of zolpidem a night).
      • Not drive, operate machinery, or work at heights until at least 8 hours after taking zolpidem.
      • Not take zolpidem with alcohol, illicit drugs, or other central nervous system suppressants.
    • The manufacturer advises that the risk of psychomotor impairment (including impaired driving ability) is increased if:
      • Zopiclone is taken within 12 hours of performing activities requiring mental alertness.
      • A dose higher than the recommended dose is taken.
      • Zopiclone is co-administered with alcohol, other CNS depressants or drugs that increase the blood levels of zopiclone.
    • It is an offence to drive while unfit due to illegal or prescribed drugs. Whilst z-drugs are not specifically listed by the law or the Driver and Vehicle Licensing Agency (DVLA), advice should be given to patients prescribed any drug which may cause drowsiness that they should not drive if they have excessive sleepiness/drowsiness. 
  • Tolerance, dependence and withdrawal syndrome may develop.
  • For more information see the CKS topic on Benzodiazepine and z-drug withdrawal. 

[MHRA, 2014; BNF, 2024; DVLA, 2024; EMC, 2021; EMC, 2024a]

Drug interactions

  • Drug interactions of Z-drugs include:
    • Alcohol and opioids — avoid concomitant use as this can:
      • Induce sedation, respiratory depression, coma, and death by potentiating effects of hypnotics.
      • Affect ability to perform skilled tasks, such as driving or operating machinery.
    • Centrally acting drugs — possible enhanced central depressive effect if co-administered with centrally acting drugs such as neuroleptics, antipsychotics, antidepressants, anaesthetics and sedative antihistamines.
    • Drugs that inhibit cytochrome P450 enzyme (for example ciprofloxacin, azole antifungals, and oestrogens).
      • Avoid concomitant use — can result in increased serum levels of Z-drugs leading to increased effect.
    • Drugs that induce cytochrome P450 enzyme (for example St John's Wort and rifampicin).
      • Cytochrome P450 inducers can accelerate hepatic elimination of Z-drugs and decrease their action.
    • Phenytoin — concomitant use may enhance sedative effect, and decrease serum concentrations of zopiclone; dose adjustments and monitoring may be required.

[BNF, 2024; EMC, 2021; EMC, 2024a]

Pregnancy and breastfeeding

Pregnancy

  • Z-drugs are not recommended in pregnancy (risk of neonatal withdrawal syndrome).
  • Use in late pregnancy or during labour may cause neonatal respiratory depression, hypothermia and hypotonia.
  • Seek specialist advice (from a psychiatrist with expertise in prescribing during pregnancy, or an obstetrician) if considering pharmacological treatment for insomnia during pregnancy.

Breastfeeding

  • Z-drugs are not recommended in breastfeeding mothers as they are excreted in small amounts in breast milk.
  • Seek specialist advice if considering prescribing z-drugs to breastfeeding mothers, as the manufacturers advise avoiding this, and because the infant will need monitoring.

 [EMC, 2021; UKTIS, 2022; BMJ Best Practice, 2023; BNF, 2024; EMC, 2024a; SPS, 2024]

Prolonged-release melatonin

Dose

The recommended oral dose of prolonged-release melatonin for insomnia for an adult aged 55 years and over is 2 mg once daily (1–2 hours before bedtime and after food) for up to 13 weeks.

[EMC, 2022; BNF, 2024]

Contraindications and cautions

  • Do not prescribe prolonged-release melatonin to people with:
    • Autoimmune disease — no clinical data available.
    • Hepatic impairment.
  • Prescribe prolonged-release melatonin with caution to people with:
    • Renal impairment — no data available.
    • Susceptibility to seizures — risk of increased seizure frequency.
    • Hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption — products contain lactose.

[EMC, 2022; BNF, 2024]

Adverse effects

  • Adverse effects of prolonged-release melatonin include:
    • Musculoskeletal disorders: Arthralgia and back pain (common).
    • Nervous system disorders: headache (common), dizziness, lethargy (uncommon), syncope, memory disturbance, restless legs syndrome, and poor quality sleep (rare).  In addition, drowsiness or sleepiness may occur (uncommon) — moderate influence on the ability to drive and use machines, use with caution if drowsiness could be associated with a risk to safety, such as when driving or using machinery. 
    • Psychiatric disorders: irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety (uncommon), aggression, agitation, disorientation, and changes to mood and libido (rare).
    • Gastrointestinal disorders: abdominal pain, dyspepsia, dry mouth, mouth ulceration, nausea (uncommon), vomiting, reflux, tongue ulceration or mucosal blistering, flatulence, halitosis (rare).
    • Other adverse effects: increased risk of infection (common), hypertension, chest pain, weight gain, night sweats, rash, pruritis, dry skin, proteinuria, glycosuria (uncommon), malaise, thirst, polyuria, haematuria, and nocturia (rare).

[EMC, 2022; BNF, 2024]

Drug interactions

  • Drug interactions for prolonged-release melatonin include:
    • Alcohol, opioids, and other drugs with CNS depressant effects —can affect ability to perform skilled tasks.
    • Fluvoxamine — fluvoxamine markedly increases melatonin levels by inhibiting its metabolism by hepatic cytochrome P450; avoid concomitant use.
    • Quinolones — quinolones are thought to increase melatonin levels; the manufacturer advises caution.
    • Oestrogens (combined hormonal contraceptives or hormonal replacement therapy) are thought to increase exposure to melatonin; the manufacturer advises caution.
    • Carbamazepine and rifampicin — may reduce melatonin levels.
    • Benzodiazepines and z-drugs (zopiclone, zolpidem) — may enhance sedation and side effects.

[EMC, 2022; BNF, 2024]

Pregnancy and breastfeeding

Pregnancy

  • Do not prescribe prolonged-release melatonin in pregnancy or to women intending to become pregnant — no clinical data available.

Breastfeeding

  • Do not prescribe prolonged-release melatonin to breastfeeding women — present in breast milk.
  • If considering prescribing medication for insomnia to breastfeeding women, seek specialist advice as products are not recommended by the manufacturers, and infants may require monitoring.

[EMC, 2022; BNF, 2024; SPS, 2024]

Daridorexant

Dose

  • Daridorexant is indicated for short-term treatment of chronic insomnia (when symptoms have been present for at least 3 months) where there is considerable impact on daytime functioning.
  • The recommended oral dose of daridorexant is 50 mg once daily, to be taken within 30 minutes before bedtime.
  • Alternatively, 25 mg once daily, to be taken within 30 minutes before bedtime. This lower dose may be more appropriate for some patients, such as those with moderate hepatic impairment.
  • The National Institute for Health and Care Excellence (NICE) technology appraisal guidance advises that:
    • 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.

[NICE, 2023a; BNF, 2024; EMC, 2024b]

Contraindications and cautions

Do not prescribe daridorexant to people with:

  • Narcolepsy.
  • Severe hepatic impairment. 

Prescribe daridorexant with caution to people:

  • With a history of depression and pre-existing psychiatric disorders (it can cause a worsening of symptoms including suicidal ideation).
  • With severe obstructive sleep apnoea (OSA) or severe chronic obstructive pulmonary disease (COPD). 
  • Over the age of 75 — limited efficacy and safety data available.
  • With a history of abuse or addiction — theoretical risk of abuse or dependence.
  • Who will be driving or operating heavy machinery or doing similarly potentially hazardous activities. Advise people not to engage in such activities unless they feel fully alert, particularly in the first few days of treatment. 

Advise people that there may be additive effects on psychomotor performance when alcohol is taken with daridorexant.

[BNF, 2024; EMC, 2024b]

Adverse effects

The adverse effects of daridorexant include:

  • Dizziness.
  • Fatigue.
  • Headache.
  • Nausea.
  • Somnolence.
  • Hallucinations.
  • Sleep paralysis.

[BNF, 2024; EMC, 2024b]

Drug interactions

Drug interactions for daridorexant include:

    • Moderate CYP3A4 inhibitors (such as diltiazem, erythromycin, ciprofloxacin, and ciclosporin) increase daridorexant bioavailability. When both drugs are required, a reduced dose of 25mg of daridorexant should be prescribed. 
    • Strong inhibitors of CYP3A4 (such as itraconazole, clarithromycin, and ritonavir) should not be prescribed concomitantly with daridorexant. 
    • CYP3A4 inducers (such as efavirenz) may reduce the efficacy of daridorexant. 
    • Central nervous system (CNS)-depressant or sedative medications — may have a potentially additive effect, and the ability to perform skilled tasks may be affected.  The manufacturer recommends caution.
    • Digoxin — daridorexant is predicted to increase exposure to digoxin when used concomitantly. The manufacturer advises caution and monitoring.

[BNF, 2024; EMC, 2024b]

Pregnancy and breastfeeding

Pregnancy

  • Avoid the use of daridorexant in pregnant women unless essential — no data available. Seek specialist advice where prescribing for insomnia in pregnancy is considered.

Breastfeeding

  • Avoid the use of daridorexant in breastfeeding women if possible, and if considering, seek specialist advice as the infant should be monitored for sedation.

[BMJ Best Practice, 2023; BNF, 2024; EMC, 2024b]

Supporting evidence

This CKS topic is largely based on the European insomnia guideline: an update on the diagnosis and treatment of insomnia 2023 [Riemann, 2023], the British Association for Psychopharmacology consensus statement Evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: an update [Wilson, 2019], clinical guidance Assessment to management of adult insomnia [AMA, 2015], the National Institute for Health and Care Excellence (NICE) medical technologies guidance Sleepio to treat insomnia and insomnia symptoms [NICE, 2022], and technology appraisal guidance Daridorexant for treating long-term insomnia [NICE, 2023a]. The rationale for individual recommendations is outlined in the relevant basis for recommendation sections of the topic.

How this topic was developed

This section briefly describes the processes used in developing and updating this topic. Further details on the full process can be found in the About Us section and on the Clarity Informatics website.

Search strategy

A literature search was conducted for guidelines and systematic reviews on primary care management of insomnia.

Search dates

January 2020 - March 2024

Key search terms

The terms listed below are the core search terms that were used for EBSCOhost MEDLINE (searched 6th January 2020). These were combined with filters to identify guidelines, systematic reviews and primary care relevant literature in EBSCOhost MEDLINE. The strategy was adapted for The Cochrane Library databases. 

S4    S1 OR S2 OR S3 
S3    AB sleep N1 problem* OR TI sleep N1 problem* 
S2    AB insomnia* OR TI insomnia* 
S1    (MH "Sleep Initiation and Maintenance Disorders+") 

Sources of guidelines

Sources of systematic reviews and meta-analyses

  • The Cochrane Library:
    • Systematic reviews
    • Protocols
    • Database of Abstracts of Reviews of Effects
  • Medline (with systematic review filter)
  • EMBASE (with systematic review filter)

Sources of health technology assessments and economic appraisals

Sources of randomized controlled trials

  • The Cochrane Library:
    • Central Register of Controlled Trials
  • Medline (with randomized controlled trial filter)
  • EMBASE (with randomized controlled trial filter)

Sources of evidence based reviews and evidence summaries

Sources of national policy

Patient experiences

Sources of medicines information

The following sources are used by CKS pharmacists and are not necessarily searched by CKS information specialists for all topics. Some of these resources are not freely available and require subscriptions to access content.

Stakeholder engagement

Our policy

The external review process is an essential part of CKS topic development. Consultation with a wide range of stakeholders provides quality assurance of the topic in terms of:

  • Clinical accuracy.
  • Consistency with other providers of clinical knowledge for primary care.
  • Accuracy of implementation of national guidance (in particular NICE guidelines).
  • Usability.

Principles of the consultation process

  • The process is inclusive and any individual may participate.
  • To participate, an individual must declare whether they have any competing interests or not. If they do not declare whether or not they have competing interests, their comments will not be considered.
  • Comments received after the deadline will be considered, but they may not be acted upon before the clinical topic is issued onto the website.
  • Comments are accepted in any format that is convenient to the reviewer, although an electronic format is encouraged.
  • External reviewers are not paid for commenting on the draft topics.
  • Discussion with an individual or an organization about the CKS response to their comments is only undertaken in exceptional circumstances (at the discretion of the Clinical Editor or Editorial Steering Group).
  • All reviewers are thanked and offered a letter acknowledging their contribution for the purposes of appraisal/revalidation.
  • All reviewers are invited to be acknowledged on the website. All reviewers are given the opportunity to feedback about the external review process, enabling improvements to be made where appropriate.

Stakeholders

  • Key stakeholders identified by the CKS team are invited to comment on draft CKS topics. Individuals and organizations can also register an interest to feedback on a specific topic, or topics in a particular clinical area, through the Getting involved section of the Clarity Informatics website.
  • Stakeholders identified from the following groups are invited to review draft topics:
    • Experts in the topic area.
    • Professional organizations and societies (for example, Royal Colleges).
    • Patient organizations, Clarity has established close links with groups such as Age UK and the Alzheimer’s Society specifically for their input into new topic development, review of current topic content and advice on relevant areas of expert knowledge.
    • Guideline development groups where the topic is an implementation of a guideline.
    • The British National Formulary team.
    • The editorial team that develop MeReC Publications.
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Patient engagement

Clarity Informatics has enlisted the support and involvement of patients and lay persons at all stages in the process of creating the content which include:

  • Topic selection
  • Scoping of topic
  • Selection of clinical scenarios
  • First draft internal review
  • Second draft internal review
  • External review
  • Final draft and pre-publication

Our lay and patient involvement includes membership on the editorial steering group, contacting expert patient groups, organizations and individuals.

Evidence exclusion criteria

Our policy

Scoping a literature search, and reviewing the evidence for CKS is a methodical and systematic process that is carried out by the lead clinical author for each topic. Relevant evidence is gathered in order that the clinical author can make fully informed decisions and recommendations. It is important to note that some evidence may be excluded for a variety of reasons. These reasons may be applied across all CKS topics or may be specific to a given topic.

Studies identified during literature searches are reviewed to identify the most appropriate information to author a CKS topic, ensuring any recommendations are based on the best evidence. We use the principles of the GRADE and PICOT approaches to assess the quality of published research. We use the principles of AGREE II to assess the quality of published guidelines.

Standard exclusions for scoping literature:

  • Animal studies
  • Original research is not written in English

Possible exclusions for reviewed literature:

  • Sample size too small or study underpowered
  • Bias evident or promotional literature
  • Population not relevant
  • Intervention/treatment not relevant
  • Outcomes not relevant
  • Outcomes have no clear evidence of clinical effectiveness
  • Setting not relevant
  • Not relevant to UK
  • Incorrect study type
  • Review article
  • Duplicate reference

Organizational, behavioural and financial barriers

Our policy

The CKS literature searches take into consideration the following concepts, which are discussed at the initial scoping of the topic.

  • Feasibility
    • Studies are selected depending on whether the intervention under investigation is available in the NHS and can be practically and safely undertaken in primary care.
  • Organizational and Financial Impact Analysis
  • Studies are selected and evaluated on whether the intervention under investigations may have an impact on local clinical service provision or national impact on cost for the NHS. The principles of clinical budget impact analysis are adhered to, evaluated and recorded by the author. The following factors are considered when making this assessment and analysis.
    • Eligible population
    • Current interventions
    • Likely uptake of new intervention or recommendation
    • Cost of the current or new intervention mix
    • Impact on other costs
    • Condition-related costs
    • In-direct costs and service impacts
    • Time dependencies
  • Cost-effectiveness or cost-benefit analysis studies are identified where available. 

We also evaluate and include evidence from NICE accredited sources which provide economic evaluations of recommendations, such as NICE guidelines. When a recommended action may not be possible because of resource constraints, this is explicitly indicated to healthcare professionals by the wording of the CKS recommendation.

Declarations of interest

Our policy

Clarity Informatics requests that all those involved in the writing and reviewing of topics, and those involved in the external review process to declare any competing interests. Signed copies are securely held by Clarity Informatics and are available on request with the permission of the individual. A copy of the declaration of interest form which participants are asked to complete annually is also available on request. A brief outline of the declarations of interest policy is described here and full details of the policy is available on the Clarity Informatics website. Declarations of interests of the authors are not routinely published, however competing interests of all those involved in the topic update or development are listed below. Competing interests include:

  • Personal financial interests
  • Personal family interest
  • Personal non-financial interest
  • Non-personal financial gain or benefit

Although particular attention is given to interests that could result in financial gains or losses for the individual, competing interests may also arise from academic competition or for political, personal, religious, and reputational reasons. An individual is not obliged to seek out knowledge of work done for, or on behalf of, the healthcare industry within the departments for which they are responsible if they would not normally expect to be informed.

Who should declare competing interests?

Any individual (or organization) involved in developing, reviewing, or commenting on clinical content, particularly the recommendations should declare competing interests. This includes the authoring team members, expert advisers, external reviewers of draft topics, individuals providing feedback on published topics, and Editorial Steering Group members. Declarations of interest are completed annually for authoring team and editorial steering group members, and are completed at the start of the topic update and development process for external stakeholders.

Competing interests declared for this topic:

None.

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