Impact of Insomnia

Insomnia affecting between 30 – 45 percent of adults¹, insomnia is characterised by one or more of the following

• Difficulty falling asleep
• Difficulty maintaining sleep
• Poor Quality of Sleep or non-refreshing sleep

All of these characteristics are associated with daytime distress or poor daytime functioning, such as fatigue, and lack of concentration.

It is estimated that primary insomnia, defined as insomnia with no other obvious underlying condition as its cause affects 1-10 percent of the general population, increasing to up to 25% in the elderly¹.

How Quality of Sleep relates to insomnia

Traditionally insomnia has been diagnosed on the basis of quantity of sleep:

• Sleep latency (time taken to get to sleep)
• Sleep duration (length of time spent asleep)

While it is important not to ignore quantity of sleep, epidemiological surveys show that poor Quality of Sleep has a greater negative impact on health, well-being and satisfaction with life than the quantity of sleep a person gets^{3 4}. Individual need for sleep differs but it is quality of that sleep which results in alertness, improved functioning the following day and better Quality of Life.

How does insomnia affect a person’s health?

Insomnia is not just a problem of the night, leaving the sufferer tired in the morning. A number of surveys have shown that leaving insomnia untreated may affect the sufferer long term, with severe impact on general health, well-being and Quality of Life^{5 6 7 8 9}.

Insomnia that affects normal functioning can be detrimental to daily life, with poor alertness and efficiency raising the risk of vehicle or occupational accidents⁷. Nearly 50% of lorry drivers admit to falling asleep at the wheel^{10 11}.

In the untreated patient, insomnia can also affect work performance. There can be a change in character and a drop of quality in work, which may be misinterpreted as laziness or lack of motivation. Increased absenteeism from work results in reduced productivity and is also uneconomical for the employer. Eventually, if the disorder remains untreated, this may even lead to reduced job prospects and loss of employment¹².

Furthermore, directly or indirectly, disrupted sleep can also have a negative effect on family life and relationships by affecting a person´s mood and the way in which they are able to perform daily activities and interact socially¹². Insomnia may create irritability or a change in mood that damages relations between couples. Family and friends may refuse to accept sleep-related disorders as illnesses and attribute sleepiness to boredom, laziness or psychological problems¹³. This can leave patients feeling misunderstood and unsupported by those closest to them. Studies have shown that people with insomnia suffer from more symptoms of hypertension, anxiety and depression than people without insomnia^{2 3}.

Clinical studies show us that poor Quality of Sleep negatively corresponds with measures of health, wellbeing and satisfaction¹.

What is the financial impact of insomnia?

Insomnia affects a large percentage of the population, particularly the elderly. Literature reports varying estimates of prevalence, a variation that relates to the lack of definition and consistency in diagnostic criteria. Nevertheless, the large number of individuals affected, along with its chronic nature, cause insomnia to convey a substantial economic burden^{14 15}.

Insomnia has been shown to be associated with increased healthcare utilisation compared with patients who did not suffer from insomnia and this consumption increases with the severity of the disease¹⁶. Insomnia patients experience significantly more limited activity and higher total health services than those without insomnia. A recent US study estimated the annual costs to be between $92.5 billion and $107.5 billion¹⁷.

The direct costs of insomnia have been shown to be split between prescription drugs, over-the counter remedies, GP consultations, tests and investigations, inpatient and outpatient hospital visits and referrals to hospital specialists. With regards to the indirect costs, they mainly include the cost of lost earnings due to absenteeism and to decreased productivity.

Two recent studies have found that absenteeism cost or absent days were about twice as high for insomnia patients as for good sleepers^{18 19}. For instance it has been demonstrated in a recent study that absenteeism costs for patients with insomnia were estimated to be $405 higher per patient than for those without insomnia²⁰. Direct costs among elderly patients with insomnia yielded costs approximately $1100 higher per patient than those patients without insomnia²⁰.

Diagnosis & treatment

With the adverse mental and physical consequences of insomnia described above, it is important to treat insomnia.

Insomnia may not be diagnosed for years and remains among the most under-diagnosed and under-treated group of medical conditions²¹. Many people do not realise that their symptoms can be attributed to insomnia.

A number of studies have shown that in insomnia, poor quality rather than quantity of sleep is associated with impaired daytime functioning and Quality of Life²². Sleep drugs however have been approved on the basis of improvements in sleep induction and/or maintenance but not in sleep quality and next day performance^{23 24}.

There are many treatments available for insomnia – the most commonly prescribed hypnotics are benzodiazepines such as temazepam and non-benzodiazepines including zolpidem and zopiclone. These primarily address insomnia related to quantitative sleep problems (increased sleep latency, shorter sleep duration) but not necessarily sleep quality. Furthermore, there is often no improvement and even impairment to daytime vigilance^{25 26}. Hypnotics are also associated with ‘hangover effects’ such as drowsiness and diminished alertness and are further associated with the development of dependence and withdrawal symptoms.

The serious potential safety concerns associated with benzodiazepine use are well known, and include addictive potential, cognitive impairment/confusion, impaired motor coordination (leading to falls and other accidents), and anterograde amnesia (memory loss after the accident that caused the amnesia)^{27 28}.

The potential for inducing confusion and falls is a particular concern in the elderly. Cognitive decline is a natural accompaniment to the ageing process which may be further exacerbated by the confusion evoked through treatment with benzodiazepines. The increased risk of falls and accidents associated with the use of benzodiazepines in the elderly often lead to fractures and hospitalisation^{29 30 31}.

Unfortunately, for elderly patients, fractures can be a major cause of morbidity and mortality due to long hospital stays, operations, rehabilitation, and the risk of infections and thrombo-embolic complications.

Rebound insomnia and residual daytime effects are also known to occur in some cases of drug withdrawal, and are generally linked with short-acting and long-acting agents, respectively³².

There is now an increasing awareness that, since sleep quality is essential to daytime functioning, pharmacological treatments of insomnia must be evaluated with respect to effects on morning alertness and withdrawal symptoms^{23 25}.

About Circadin®

Circadin® is the first and only IP-protected, prolonged-release melatonin-containing prescription medicine approved in the EU. It is indicated for short-term treatment of primary insomnia, characterised by poor Quality of Sleep, in patients aged 55 years and above³³.

The regulatory approval of Circadin® for this indication represents a new therapeutic principle in insomnia therapy. Circadin® has been shown to improve sleep quality, allowing for better Quality of Life, and is the only insomnia medicine shown to improve daytime performance. Furthermore, unlike the benzodiazepine and non-benzodiazepine hypnotics, Circadin® treatment is not associated with memory impairments, residual daytime or hangover effects.

Circadin® has demonstrated a favourable safety and tolerability profile with no rebound or withdrawal effects seen in clinical studies, and represents a new and valuable treatment for insomnia³³.
British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders recommends Circadin as first line treatment for insomnia patients aged 55 and older. British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders recommends Circadin as first line treatment for insomnia patients aged 55 and older³⁴.