IPN 2023 March

Management of Sleep Disorders: The Role played by Community Pharmacists in Advising, Managing, and offering OTC Treatment advice to those suffering from sleep disorders

60 Second Summary

Sleep plays a vital role in the maintenance of optimal physical and mental health. Unfortunately, sleep disorders are highly prevalent and approximately 10% of the adult population suffers from insomnia. Several chronic physical and mental health conditions are linked to sleep deprivation and sleep disruption. Sleeping less compared to your individual sleep need results in sleep deprivation and if the continuity of sleep is disturbed, it results in poor sleep quality and both sleep deprivation and disruption has daytime consequences. There are multiple factors that can cause sleep disruption and presence of sleep disorders is one of them.

The International classification of sleep disorders – 3rd edition (ICSD – 3) details different categories of sleep disorders and their diagnostic criteria. The most common sleep disorders are insomnia and sleep breathing disorders followed by sleep related movement disorders.

Cognitive behavioural therapy for insomnia (CBT-I) is a validated non-medication method to treat insomnia and is the first line treatment for chronic insomnia.

Pharmacological treatment should be considered if CBT-I is unsuccessful or not available or as an adjunct to CBT-I.

Pharmacists have an important role in the management of acute insomnia to prevent the progression to chronic insomnia by assessing, providing the sleep hygiene education, and managing the short-term sleep difficulties using over the counter sleep aids as deemed appropriate. Pharmacists can also aid by evaluating the symptoms and by advising on the referral pathway to each individual patient.

AUTHOR: Motty Varghese RPSGT, Sleep Physiologist

Motty completed his BSc in (Allied Health Sciences) with specialisation in Respiratory physiology in 2000. He registered with the Board of Polysomnography Technologists in the United States in 2008 after acquiring his international RPSGT certification. Motty attended training programmes in CBT-I in Circadian and neuroscience institute in the University of Oxford and completed a mini-fellowship in Behavioural Sleep Medicine from Perelman School of Medicine at the University of Pennsylvania. He worked as a Senior Respiratory and Sleep Physiologist at St. James’s Hospital from 2003 to 2018.

Motty currently manages the Sleep Therapy Clinic, a Behavioural Sleep Medicine clinic where he offers non-medication treatment for insomnia and circadian rhythm disorders, and sleep diagnostic services. Motty is a member of the Irish Sleep Society and the European Sleep Research Society.

1. REFLECT - Before reading this module, consider the following: Will this clinical area be relevant to my practice?

2. IDENTIFY - If the answer is no, I may still be interested in the area but the article may not contribute towards my continuing professional development (CPD). If the answer is yes, I should identify any knowledge gaps in the clinical area.

3. PLAN - If I have identified a

knowledge gap - will this article satisfy those needs - or will more reading be required?

4. EVALUATE - Did this article meet my learning needs - and how has my practise changed as a result? Have I identified further learning needs?

5. WHAT NEXT - At this time you may like to record your learning for future use or assessment. Follow the

4 previous steps, log and record your findings.

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Sleep plays a vital role in the maintenance of optimal physical and mental health. While sleep is a state elicited by the brain, its benefits reach far beyond brain health and even play a role in the maintenance of cellular homeostasis. Although the functions of sleep are still not fully understood, several studies have identified the restorative role sleep plays in learning, memory formation, mood regulation, brain health in general, peripheral body functions, immunity, cardiovascular and metabolic functions. The effect of sleep on maintaining alertness and keeping humans safe while performing safetycritical tasks (driving, working at heights, industries) is unequivocal.

It is a widely accepted fact that sleep deprivation/sleep disruption is very common with numerous physical and mental health related consequences of short and longterm nature. Sleep deprivation is when a person doesn’t get enough sleep compromising the total sleep quantity compared to his individually unique sleep need. The American Academy of Sleep Medicine recommends a sleep duration of over 7 hours. While sleep deprivation affects the quantity of sleep, sleep disruption affects the continuity of sleep, and thereby affecting the quality

of sleep. Sleep disruption can be caused by numerous factors including lifestyle, environmental factors, the presence of sleep disorders, and other medical conditions. In sleep deprivation and sleep disruption, sleep architecture is affected and will have daytime consequences. In a recent survey carried out among pharmacists in Ireland, it was reported one in four individuals approaching the pharmacist/pharmacy users had difficulty falling asleep, 20% reported multiple awakenings at night and 18% reported difficulty returning to sleep.

Pharmacists also reported the main issue which causes individuals to have sleep issues is stress and anxiety, followed by anxiety about sleep and environmental factors.

Figure 1: Factors that cause sleep disruption

Sleep architecture

Sleep is broadly divided into two stages – non-rapid eye movement sleep (NREM sleep) and rapid eye movement sleep (REM sleep). NREM sleep is further divided into stages 1, 2 and 3 (previously stages 1, 2, 3, and 4) sleep. Stage 3 sleep is also called slow-wave sleep or delta sleep. Each stage of sleep has its own different functions. Stage 3 sleep is the most restorative type of sleep allowing for bodily tissue repair and growth and typically occurs in the first half of the night. Slow-wave sleep also plays a significant role in the formation of declarative memory by processing and consolidating newly acquired information. REM sleep occurs mostly in the second half of the night and helps you process emotional memories, which can reduce the intensity of emotions and in the formation of procedural memory, helping you to learn and remember the various steps involved in performing a particular task. While the above mentioned are some of the functions of sleep, they are not limited to that.

Prevalence of sleep difficulties

A Centre for Disease Control and Prevention (CDC) survey in 2014 reported that only 65% of adults reported a healthy duration of sleep, and an estimated 83.6 million adults in the United States were reportedly sleeping <7 h in 24 h.

A recent study of the prevalence of sleep disorders investigated over 20,000 patients in the Netherlands who were aged 12 years old or older found an alarming prevalence

rate of 27.3%, with 21.2% of the males and 33.2% of the females reporting that they had some type of sleep disorder.

Figure 2: Hypnogram depicting the sleep architecture in a normal sleeper

Insomnia is the most reported sleep disorder. The prevalence of insomnia is approximately 10% in the adult population and another 20% experiences occasional insomnia symptoms as per the research done by Prof. Charles Morin who is a professor of Psychology and eminent sleep researcher.

In a systematic review aimed at determining the prevalence of obstructive sleep apnea in adults in the general population, the prevalence ranged from 9% to 38% and was higher in men.

A survey was carried out among pharmacists in Ireland in January 2023 to understand how pharmacists experience and manage their customers’ sleep issues. More than 50% of the 240 pharmacists surveyed reported approximately 11% or more of pharmacy users consult pharmacists about sleep and 11% or more purchase sleep aids in a week, which is a clear indicator of the increased prevalence of sleep problems in this country.

Sleep and mental health

Traditionally, sleep problems have been viewed as a consequence of mental health problems. Evidence also suggests that problems sleeping can contribute to the formation of new mental health problems and to the maintenance of existing ones. In other words, sleep has a bidirectional relationship with mental health, with problems sleeping likely to influence both the onset and trajectory of a variety of mental health difficulties.

Figure 3: Classification of sleep disorders based on ICSD-3

A persistent state of anxiety, lasting for at least 6 months, is characterised as Generalised anxiety disorder. Generalised anxiety disorders are the most prevalent mental disorder among subjects complaining of insomnia. Approximately, 60% to 70% of patients with GAD also complain of insomnia.

Sleep onset and sleep maintenance insomnia is reported widely among patients who suffer from depression. In a UK population sample, 83% of depressed patients had at least one insomnia symptom, compared with 36% who did not have depression. The association between sleep breathing disorders and depression is also well established.

In the Pharmacist Sleep Survey of 2023 (Ireland), 47% of pharmacists identify customers who may have sleep issues when they report a history of anxiety/depression.

Sleep disorders

The international classification of sleep disorders (ICSD-3) published in 2014 by the American Academy of Sleep Medicine is one of the authoritative texts for the diagnosis of sleep disorders and classifies sleep disorders into seven major categories.

• Insomnia

• Sleep-Related Breathing Disorders

• Central Disorders of Hypersomnolence

• Circadian Rhythm Sleep-Wake Disorders

• Parasomnias

• Sleep-Related Movement Disorders

• Other sleep disorders

Some of the sleep disorders and their general characteristics are discussed below, but the list and information is not exhaustive and further reading is recommended.

Insomnia

An insomnia disorder is defined as a persistent difficulty with sleep initiation, duration, or consolidation that occurs despite adequate opportunity and circumstances for sleep and results in concern, dissatisfaction, or perceived daytime impairment, such as fatigue, decreased mood or irritability, general malaise, or cognitive impairment.

Acute insomnia is often the result of an acute source of stress and tends to last from a few days to few weeks. Once the stressful period is over, sleep tends to return to normal. The annual incidence of acute insomnia in the UK is between 31.2% and 36.6%.

Figure 4: Clinical algorithm for the diagnosis and treatment of

Some individuals can develop perpetuating factors including maladaptive behaviours and dysfunctional beliefs and this results in insomnia lasting for a longer period and becoming chronic. The essential feature of chronic insomnia disorder is frequent and persistent difficulty initiating or maintaining sleep that lasts at least 3 months and results in general sleep dissatisfaction or perceived impairment, reported by the patient or a caregiver.

Management of insomnia

The pharmacist is in a unique position to assist with the assessment and management of acute insomnia since pharmacists are the professionals who are contacted at the beginning of sleep difficulties, often to resolve the sleep difficulty while the individual is in the pursuit of obtaining ‘over-the-counter’ medications. A thorough assessment is mandatory to establish the nature of sleep difficulty to confirm insomnia and the duration of the symptoms to confirm its acute nature.

Management should include sleep hygiene education to correct the maladaptive behaviours they may have already developed. For instance, a tendency to compensate for lost sleep by waking up late or going to bed

early, or taking long naps is very common and this can result in worsening of their insomnia. Sleep education is of paramount importance to encourage the individual to adopt optimal sleep habits. These optimal sleep habits will help them to optimise their homeostatic sleep drive and enable them to sleep better.

Pharmacological intervention in the form of non-prescription, over-the-counter sleep aids is widely used in the treatment of acute or short-term insomnia. It is the decision of the pharmacist to use OTC sleep aids depending on their efficacy and safety based on the currently available data. The dosage and duration of administration should be closely monitored.

Diphenhydramine is one of the commonly used over-the-counter sleep aids. Diphenhydramine has sedative qualities and caution should be exercised when it is provided to someone who engages in safety-critical tasks due to the residual sleepiness it may cause. It is also not generally recommended for use in older adults due to the risk of fall and other undesired effects.

Cognitive Behavioural Therapy for Insomnia (CBT-I) is recommended as the primary intervention in individuals with Insomnia as per

the Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. Medications for chronic insomnia disorder should be considered mainly in patients who are unable to participate in CBT-I, who still have symptoms despite participation in such treatments, or, in select cases, as a temporary adjunct to CBT-I.

The following clinical algorithm is recommended for the management of Insomnia by the European guideline for the diagnosis and treatment of insomnia. (See figure 4)

Sleep breathing disorders

Obstructive sleep apnoea syndrome (OSA) is characterised by repetitive episodes of upper airway obstruction that occur during sleep, usually associated with a reduction in blood oxygen saturation or brief microarousals from sleep.

OSA is characterised by loud snoring or brief gasps that alternate with episodes of silence that usually lasts 20 to 30 seconds. Patients are usually unaware of the loud snoring and breathing difficulty or of the frequent arousals and brief awakenings that occur throughout the night and it is often the bed

partner who reports the difficulty. The obstruction during sleep is mostly caused by nasopharyngeal anomalies that narrow the upper airway. Although obstructive sleep apnoea syndrome is frequently connected with obesity, some patients with this condition are not overweight; severe obesity is only found in a minority of patients. The likelihood of craniofacial anomalies like micrognathia or retrognathia is higher in the absence of obesity. Excessive daytime sleepiness is another classic feature of obstructive sleep apnoea and requires evaluation, diagnostic testing, and management by a Respiratory/Sleep specialist.

Parasomnias

Parasomnias are disorders characterised by the occurrence of complex motor or behavioural events or experiences at the onset of sleep, during sleep or during arousal from sleep. During parasomnia events, abnormal sleep-related complex movements, behaviours, emotions, perceptions, dreams and autonomic nervous system activity may occur which are potentially harmful and can cause injuries (also to the bed partner), sleep disruption, adverse health consequences and undesirable psychosocial effects. They are divided into NREM-related parasomnias, REM-related parasomnias, and other parasomnias. Confused arousals, sleepwalking, sleep terrors, sleep-related eating disorder and disorders of arousal are examples of NREM-related parasomnias. NREM sleep includes stages 1,2 and 3 of sleep and REM sleep is rapid eye movement sleep where dreams occur. REM-related parasomnias include REM sleep behaviour disorder, recurrent isolated sleep paralysis, and nightmare disorder. Examples of other parasomnias include exploding head syndrome, sleep enuresis, and sleep-related hallucinations.

Sleep related movement disorders

The most reported sleep-related movement disorders are restless

legs syndrome (RLS), periodic limb movement disorder, and bruxism. Sleep disruption or daytime fatigue/sleepiness is needed for the diagnosis of a sleep- related movement disorder.

The common symptoms of RLS are an urge to move the legs usually accompanied by an unpleasant sensation in the legs that begin or worsens during periods of rest or inactivity and is partially or totally relieved by movement. These symptoms occur predominantly or exclusively in the evening or night rather than during the day. The predisposing and precipitating factors for RLS are iron deficiency, medications, pregnancy, chronic renal failure, and prolonged immobility.

Periodic limb movement can occur during sleep or wakefulness, and they should be accompanied by a complaint or objective sleep disturbance to be considered a disorder. A polysomnography (an overnight sleep test) should show a movement frequency of >15/hour in adults and >5/hour in children. PLMs can cause clinically significant sleep disturbance and when the PLMs are not explained by another current sleep disorder, medical, mental, or neurological disorder, a diagnosis of PLMS is considered.

Bruxism is characterised by cranial muscle involvement, with clenching or grinding of the teeth and/ or by bracing or thrusting of the mandible. Typically, sleep bruxism is characterised by tooth-grinding sounds and results in abnormal tooth wear, tooth pain, jaw muscle pain, and temporal headache.

Circadian rhythm sleep-wake disorders

Circadian rhythm disorders share a chronic or recurrent pattern of sleep-wake rhythm disruption primarily due to the mismatch between the endogenous circadian timing system and the sleep-wake schedule desired or required by an individual. In circadian rhythm disorders, an individual may find it difficult to maintain their major sleep phase aligned to the socially acceptable sleep phase. Some common circadian rhythm disorders are delayed sleep phase disorder, advanced sleep phase disorder, Shift work disorder and Jet lag disorder.

Delayed sleep phase disorder (DSPD) is characterised by the delay of the sleep-wake timing.

The delay is usually longer than 2 hrs and with difficulty in falling asleep at a socially acceptable time. This can result in a reduction of sleep duration and can affect the individual’s academic performance or professional life. The predisposing and precipitating factors for this disorder are evening chronotype (night owl), adolescent age, inappropriate light exposure, etc.

In advanced sleep phase disorder (ASPD), a habitual advance of the major sleep episode happens with sleep onset and final awakening happening by at least 2 hours earlier than the desired/socially acceptable time. ASPD is generally seen in older individuals, and who have a significant tendency towards morningness.

Central Disorders of Hypersomnolence

The primary complaint in the disorders included in this group is the inability to stay awake and alert during the major episodes of wakefulness during the day, resulting in periods of irresistible sleep or involuntary bouts of drowsiness or sleep. Daytime sleepiness should not be caused or explained by disturbed nocturnal sleep or altered circadian rhythms. Sleep disorders in this group include narcolepsy type 1 and 2, idiopathic hypersomnia, kleine-levin syndrome, hypersomnia due to medications, substance, or due to a medical or psychiatric disorder and insufficient sleep syndrome.

Assessment and management of sleep-related complaints

Pharmacists are in a suitable position to play an appropriate and vital role to identify sleep difficulties and improve sleep health management. Among the sleep disorders mentioned above in the ICSD – 3 classifications, Insomnia is one of the sleep disorders that Pharmacists can be of assistance and timely intervention is useful to prevent the progression of acute insomnia to chronic insomnia.

Assessment tools like, the Epworth Sleepiness scale, sleep diary to establish baseline sleep patterns, Global sleep assessment questionnaire, and sleep disorder symptom check- list are all valid tools to assess sleep health to decide on referral and further management. Careful evaluation is mandatory in identifying the symptoms and

advising the referral pathway to the concerned individual/patient. Excessive daytime sleepiness or fatigue is a common symptom in most sleep disorders due to sleep disruption (multiple awakenings) and sleep deprivation. A thorough evaluation by a specialist is warranted to identify the causal factors of sleep disruption. Full polysomnography (PSG), a diagnostic test that looks at a number of physiological variables (EEG, EMG, ECG, respiratory and abdominal efforts, oronasal airflow, SpO2, and limb movements) is required in the diagnosis of sleep disorders. Other investigations like multiple sleep latency tests or maintenance of wakefulness tests are helpful in the evaluation of central disorders of hypersomnolence in addition to the PSG but are not limited to that. Sleep diaries and actigraphy measurements are useful in the evaluation of individuals with Insomnia and circadian rhythm disorders. A referral to a sleep specialist or a respiratory physician (in the case of a suspected sleep breathing disorder) is mandatory for evaluation and further management.

Pharmacists can be resourceful for patients in the management of acute insomnia by providing sleep hygiene education and over the counter sleep aids. It is the decision of the pharmacist to use OTC sleep aids depending on individual suitability, their efficacy and safety based on the currently available data. The contraindications, dosage and duration of administration should be closely monitored.

Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment option for chronic insomnia and pharmacological treatment is generally considered when CBT-I is not successful or unavailable. Medications are also used as a temporary adjunct to CBT-I. CBT-I is delivered by a Behavioral Sleep Medicine Practitioner (Sleep Therapy Clinic www.sleeptherapy.ie).

Summary

The prevalence of sleep disorders is high in the modern industrialised society with multifaceted health consequences and impacts on individuals’ quality of life. Treating and preventing sleep disorders will have a significant impact on physical and mental health-related outcomes and pharmacists are in a unique position to contribute.

Assessing and managing insomnia and educating individuals about sleep hygiene during the early phase using evidence-based methods helps to prevent the progression of it to a chronic condition. Identifying the symptoms of other sleep disorders and advising individuals on the referral pathway to resolve their sleep difficulty is another area where pharmacists can be resourceful.

Recommended reading:

Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.

International classification of sleep disorders – 3rd edition (ICSD – 3) References available on request

Question your Understanding

1. What is ICSD - 3 and what are the different types of sleep disorders?

2. What is the difference between acute insomnia and chronic insomnia and who can be treated in the pharmacy?

3. What are the nonmedication methods to treat insomnia?

4. What are the common sleep disorders, and do you know the symptoms of them to identify and refer to a GP or a specialist?

5. What are the factors that cause sleep disruption?