Insomnia is one of the most common sleep disorders which is characterized by complaints regarding difficulty falling asleep, staying asleep and/or waking up too early without being able to return to sleep (Diagnostic and statistical manual of mental disorders 5 ,2013). These complaints may result in insufficient sleep and/or poor quality of sleep. As lack of sleep generally leads to negative consequences during waking hours, so does insomnia. Some common daytime impairment that people with insomnia report are fatigue, irritability, prone to commit errors, poor concentration, poor motivation, and memory impairments (Neubauer, 2013). The before mentioned commonly reported daytime impairments can have a significant negative impact on an individuals’ occupational, physical, social as well as educational, academic, and behavioral performance (Drake, Roehrs & Roth, 2003; DSM 5, 2013). If prolonged for a longer period of time, these negative consequences of insomnia negatively affect several domains of a persons’ Quality of life (QoL) (Zammit, Weiner, Damato, Sillup & McMillan,1999; L??ger, Scheuermaier, Philip, Paillard & Guilleminault, 2001; L??ger, Scheuermaier, Raffray, Metlaine, Choudat & Guilleminault, 2005). QoL has been defined by the Worlds Health Organization (1995), as the way a person perceives his or her position in life regarding their expectations, goals, concerns and standards, in the context of the culture and value system in which they live. QoL is a concept that has a multi-dimensional nature. It is related to many aspects of an individuals’ life since QoL gives an impression of the extent of satisfaction people have with their physical state, their affective and cognitive state as well as their social roles and interpersonal relationships and how these affect their daily life (Ruta, Camfield & Donaldson , 2007; World Health Organization, 1995).
During the years there have been several pharmacological as well as non-pharmacological treatments given to individuals who suffer from primary insomnia. Due to their improvement of sleep, they may also positively affect certain aspects QoL (Scalo, Desai & Rascati, 2013). Some of the pharmacological treatments that have been used include barbiturates, benzodiazepines, and non-benzodiazepine hypnotic. However, these medicines can have side-effects such as drowsiness, dizziness, hallucinations, cognitive impairments and also impairments of the memory. There have been medications that are known to lead to tolerance, increase the risk for developing dependence and some also lead to abuse. All of which could negatively influence a person’s QoL (Bhat, Shafi & Solh, 2008; Masters, 2014). On the other hand these medications help to relieve the symptoms that they are meant for, which may then increase QoL of insomnia sufferers in certain aspects. Thus, due to their side-effects it is possible that these medications decrease the QoL of an individual, but if they do relieve insomnia symptoms, it can mean an increase of the QoL (Sasai, Inoue, Komada, Nomura, Matsuura & Matsushima, 2010).
Cognitive Behavioral Therapy, a non-pharmacological treatment, has repeatedly been shown to be efficacious in the treatment of insomnia (Vitiello, McCurry & Rybarczyk, 2013).
The main goal of this treatment is to challenge the cognitive and behavioral variables that may maintain insomnia complaints over time. Common factors that need to be challenged are for example sleep anxiety, irrational and maladaptive thoughts about sleep, irregular sleep schedule, daytime napping and the spending of excessive amounts of time in bed (Hood, Rogojanski & Moss, 2014; Mitchell, Gehrman, Perlis & Umscheid, 2012; Nolen-Hoeksema, 2011). There are several techniques available to target these factors, including teaching the patient the practice of good sleep hygiene and the provision of accurate information about sleep. Furthermore, there are techniques such as sleep restriction, where the amount of time spent in bed is restricted to the mean amount of time that the patient actually spends asleep, stimulus control, where the aim is to recreate a conditioned association between bed/bedroom and sleep and cognitive restructuring (Hood, et al., 2014). Finally, with fewer known side effects than pharmacotherapy (Morin, 2011), it could be expected that CBT unlike pharmacotherapy, will not have side effects which lead to the impairment of QoL (neubaer, 2013).
There is a large pool of research on the effects of pharmacological treatments or non-pharmacological treatments on different variables related to insomnia e.g., sleep latency, sleep quality, duration of sleep, and duration of awakenings (Morin, 2011; Mitchell, et al., 2012). While not much research has been done regarding effects of these treatment options on variables related to QoL of insomniacs. Hence, the first aim of this study is to investigate which domains of QoL are affected in people with primary insomnia that do not use any treatment when compared to good sleepers. An overview of which domains of QoL are negatively affected by insomnia will make it possible to see if improvements on a specific domain after treatment are due to the actual positive effects of the treatment itself or if that domain is normally not affected by insomnia. The second and main aim is to find out which treatment improves more domains of QoL for individuals who suffer from primary insomnia.
The first research question that will be asked in this review paper is which domains of quality of life are negatively affected in insomniacs who do not use any kind of treatment when they are compared to good sleepers. The second research question is: whether CBT improves more domains of QoL than medication when compared to QoL in insomniacs who do not use any treatment.
To gather information for this review paper a literature search has been used with databases PsychINFO, CINAHL, psychARTICLES, PsychBOOKS, PubMed and the online library of Maastricht University. Keywords that have been used were insomnia, primary insomnia, Cognitive-behavioral therapy, non-pharmacological treatments, pharmacological treatments, hypnotics, zolpidem, zopliclone, temazepan, Quality of life and QoL.
In order to answer the first research question, it was attempted to first look at how scores in the different domains of QoL are affected in people with insomnia that do not use any treatment compared to good sleepers. The approach taken in order to answer the second research question was by first comparing QoL of patients who use medication to that of those who do not use any treatment and secondly, compare QoL of patients who use CBT as a treatment with those that do not use any treatment.
For the present review, only three questionnaires related to quality of life were used. These were the 36-item short-form, 12-item short form and the 8-item short form (Lefante, Harmon, Ashby, Barnard & Webber, 2005; Ware, Kosinski & Keller, 1996; Ware, 2000). These questionnaires were developed so that scores on one of these questionnaires can be compared in a standardized way to those on one of the other questionnaires (Lafante, et al., 2005; Ware & Sherbourne, 1992; Ware, 2000). These multi-item scales are divided into physical health component summaries (PCS), under which the domains: physical functioning, role limitation due to physical functioning, bodily pain and general health perceptions fall. Next to the physical health component summary, there are the mental health component summaries (MCS), which contain the domains: vitality, social functioning, role limitation due to emotional problems and general mental health (Ware & Sherbourne, 1992; Ware, 2000). Participants have to answer a series of questions related to a specific domain. The provided answers will then be accumulated so that an overall score can be given to that specific domain. A higher score translates naturally to a better QoL, while a lower score translates to a lower QoL.
Only the three abovementioned questionnaires were considered for the present study, considering that this way it can be easier to compare QoL scores in one study with those of other studies. Furthermore, when comparing these questionnaires, there is no need to hold into account that the methodological methods are different.
All the articles reviewed in this article have used patients that suffer from primary chronic insomnia. Articles that have used subjects with co-morbid primary insomnia were left out of consideration.
Finally, although there are several classes of prescription drugs available, such as barbiturates, benzodiazepines, and non-benzodiazepine, in the present study, only the class non-benzodiazepines will be considered. These include Zolpidem, Zaleplon and Eszopiclone. The reason why non-benzodiazepines will be considered is because they are associated with fewer side effects than benzodiazepines and barbiturates. Furthermore they have been shown to be more effective as well as safer (Masters, 2014).
1. QoL in insomnia patients who do not use any treatment.
In this section QoL of untreated insomniacs will be compared to that of people who do not have insomnia. This provides the opportunity to see which domains of QoL are more negatively affected in insomnia and at the same time provide an answer to the first research question. This overview will be used later on to see how these domains are affected by the different treatment options.
L??ger et al. (2001) conducted a study in which the impact on QoL by insomnia was evaluated. To do this the QoL of three matched groups were compared. These groups consisted of people with severe symptoms of insomnia (n=240), people with mild symptoms of insomnia (n=422) and good sleepers (n=391). Severe insomnia was defined in this study as experiencing a minimum of 2 sleep complaints for at least 3 times a week during a period of 1 month together with complaints of daytime impairment. Mild insomnia was defined as experiences of occasional sleep difficulties that did not meet the criteria to be categorized as severe insomnia nor as good sleeper. To assess the QOL of these participants, the SF-36 questionnaire was used. Results showed that participants with severe symptoms of insomnia scored significantly lower on all 8 domains when compared to the mild insomniacs and the good sleepers. Furthermore, mild insomnia was also associated with significantly lower scores on QoL when compared to good sleepers. These results show that the more severe the insomnia symptoms become the lower QoL gets.
In a more recent study by Scalo et al. (2013), an epidemiological study was conducted in which the main aim was to assess the effects of insomnia and prescription hypnotics use on the QoL of insomnia patients. However, first QoL of insomniacs (n=1401) was compared to those of good sleepers (n=104274). In addition, the insomnia group was further divided into insomnia patients who did not use hypnotics (n=762) and insomnia patients who did use hypnotics (n=639). QoL was measured by using the SF-12 questionnaire. Results show that there is a significant reduced QoL in the insomnia group when compared to the good sleeper group. This reduced QoL in the insomnia group was observed in both PCS and MCS.
Sasai et al. (2010) used the Pittsburgh Sleep Quality Index (PSQI) to categorize subjects into good sleepers (n=2070), good sleepers using sleep medication (n=95), insomniacs (n=264) and insomniacs using sleep medication (n=85). PSQI evaluates patients’ sleep quality based on their reported sleep latency, sleep duration, their usual sleep efficiency, how often their sleep is disturbed, and the dysfunctions they experience during the day. Those who had a sum score on the before mentioned items greater than 1 standard deviation from the mean sum score (6.4) were categorized as insomniacs. Comparisons of the insomniac group and the good sleepers group showed that based on the SF-8, insomniacs scored significantly lower on both MCS and PCS than the good sleepers.
L??ger, Morin, Uchiyama, Hakimi, Cure and Walsh (2012) conducted a cross-sectional survey in the US, France and Japan. The aim was to assess QoL in people with chronic primary insomnia and to compare them with good sleepers. Based on their score of the Insomnia Severity Index, participants were categorized as good sleepers (n=1982) or chronic insomniacs (n=2085). Of the 2085 who suffered from chronic insomnia, 832 were being treated during the study. Results showed that patients with chronic insomnia reported a significantly lower QoL on all domains of the SF-36 when compared to good sleepers. In addition, the domains vitality, social functioning, role limitation due to emotional problems and mental health were the ones most negatively affected.
Fornal-Paw??owska and Szelenberger (2013) conducted a study in which the primary goal was to assess the efficacy of CBT as a treatment for chronic insomnia. QoL measures of the insomniacs assigned to CBT (n=51) were obtained at baseline and after treatment. Subsequently these scores were compared to those of good sleepers (n=51) who functioned as the control group. Contrary to what was found in previously reported studies, it was found that the insomniacs did not differ significantly from the scores of the good sleepers on the SF-36 forms related to the physical health.
The previously presented studies show that except for one study Fornal-Paw??owska and Szelenberger (2013), the majority of the studies found significantly lower QoL scores in untreated insomnia when compared to good sleepers. Furthermore, these lower scores were seen in all of the domains of QoL.
2. QoL of insomnia patients who use Pharmacological treatment
In the previous section it was shown that insomnia negatively affects all domains of QoL. The goal of this section is to assess whether the use of hypnotics as a means of improving the insomnia symptoms leads to an improvement in certain domains of QoL, and which those domains are. In addition, the answer to this question serves as a part to answer the second research question.
In the article by Scalo et al. (2013) described in section 1, insomniacs who used hypnotics where compared to those who do not use hypnotics. Results show that the use of hypnotics does not lead to a significant improvement in QoL. This suggests that medication does not lead to improvement in QoL, because as it has been shown in the previous section, most studies find impaired QoL levels in insomniacs who do not use any medications. If medications would improve sleep as well as QoL, then there should be significant difference in the QoL of people who use medications and those who do not use any medication.
In the article by Sasai et al. (2010), discussed in the previous section it was found that comparison of all the 4 groups based on their MCS and PCS scores shows that firstly, insomniacs using sleep medication scored significantly lower than good sleepers, insomniacs and the good sleepers using medication. Secondly, good sleepers that used medications had a significantly lower score than the good sleepers that do not, but these good sleepers who used medications scored significantly higher on the MCS compared to the insomniacs. However no significant difference was found for the PCS when good sleepers using medications were compared to insomniacs using medication. From the results obtained in this study it can be said insomniacs using sleep medications did not see any improvement on their QoL from the use of medication when compared to the other conditions. Furthermore, there even seems to be a negative effect of medication on QoL, due to the fact that insomniacs who use medication score significantly lower than insomniacs who use no medication.
As has been mentioned in the previous section regarding the article by L??ger et al. (2012), 832 of the participants who suffered from insomnia were being treated during the study. In France and in the US, most patients receiving treatments reported using non-benzodiazepines as a prescription drug (48% and 50%, respectively) and in Japan, a majority of the patients who were being treated reported using benzodiazepines as a prescription drug (47%).Of those who were not receiving treatment during the study, 14% in Japan and 34% in the US reported using some form of treatment during the last 3 years. Comparisons of these patients who were receiving treatment to those not receiving any treatment showed that in US and France, the previous had significantly higher scores on MCS compared to the latter. However, no significant difference was seen on the PCS. Moreover, none of the dimensions of the SF-36 were significantly different when treated individuals were compared to untreated individuals in Japan. These results suggest that the use of non-benzodiazepines for insomnia did lead to significant improvement on the MCS dimension of QoL, while this was not the case for the PCS dimension. Moreover, benzodiazepines do not improve the MCS or the PCS dimensions of QoL.
Another study in which the effects of hypnotics on QoL were examined is the article by Walsh et al. (2007). In this study, primary insomniacs were compared to a placebo group to measure the effects of 6 months of nightly use of the hypnotic Eszopiclone on the QoL. QoL of these two groups were measured before the study began and after the 1st, 3rd and 6th month. This was done by using randomized, double blind, controlled clinical trials. A total of 828 patients were recruited, where 548 were randomly assigned to the group that got Eszopiclone as a medication for their insomnia and 280 were randomly assigned to a placebo group. Results on the SF-36 questionnaire showed that after 1 month, patients that had been using eszopiclone scored significantly higher in vitality, social functioning and physical functioning. After 3 months the domains vitality and social functioning were significantly different from scores of the placebo group. Finally, the domains vitality, social functioning, physical functioning, bodily pain and the MCS scored significantly higher compared to the placebo. From these results it can be said that the use of eszopiclone as medication for insomnia does bring about benefits for certain domains of QoL, however this is not the case for the rest of the domains. In addition, as the period of hypnotic use increases, more domains of QoL began to benefit from the use of eszopiclone.
From the results obtained in this section, it can be concluded that there are mixed findings regarding improvements in the QoL due to pharmacological treatments .In some cases no improvements were seen at all, in other improvements were seen in some domains, while in one study there was even a negative effect seen due to the use pharmacology.
3. Quality of life of insomnia patients who use psychological treatment
The aim of this section is to investigate whether there is an improvement in QoL of insomnia patients after treatment with CBT and which the domains that improve are. Results from this section can be used in addition to those obtained in the previous section in order to give an answer to the second research question.
In the first section the article by Fornal-Paw??owska and Szelenberger (2013) has been discussed, in which the authors attempted to assess the efficacy of CBT as a treatment for chronic insomnia compared to good sleepers. Results show that after the CBT a considerable improvement was noted on the domains energy and social functioning. Changes obtained during the treatment were still present at a 3- month follow-up. Additionally, the domains role limitation due to emotional problems and emotional well being also showed significant improvement at a 3 month follow-up, when compared to assessment at the end of the treatment. Moreover, 3 months after the therapy has ended the domains energy, social functioning and role limitations due to emotional problems where at the same level as that of healthy controls. Thus from these results it can be said that CBT positively benefits certain dimensions of the QoL and even leads to QoL scores similar to that of good sleepers.
In a study conducted by Omvik et al. (2008) a randomized controlled trial was used to compare efficacy of cognitive behavioral therapy, hypnotic treatment in this case Zopiclone, and placebo for insomnia patients on several parameters including QoL. 55 patients who qualified as primary insomniacs participated in this study. The participants were randomly divided into a CBT group (n=18), a Zopiclone group (n=16) and a placebo group (n=12). Assessments took place at baseline, post-treatment and at 6 months after completion of the treatment. At baseline, all the participants scored marginally lower than the standardized population (M=50, SD=10) on the SF-36. In addition, no significant difference was found for neither CBT nor Zopiclone when post-treatment was compared to pre-treatment. This suggests that CBT treatment does not lead to improvements in the QoL of patients with insomnia.
In the article by Tomeny, Dixon, Morgan, Mathers and Thompson (2006), surveys of QoL were combined with data from a randomized controlled trial of CBT for patients with chronic insomnia who had been using hypnotics. The aim was to compare QoL scores of hypnotic users with chronic insomnia with that of long-term users of drug in a primary care. In addition, the effectiveness of CBT on the SF-36 score for the people with chronic insomnia that use hypnotics was evaluated. These outcomes were measured at baseline, and at a 3-, and 6- month follow up. The participants reported using different medication that ranged from temazepam, nitrazepam and zopiclone. A total of 108 insomniacs and 101 control patients participated in this study, where 76 insomniacs and 72 control patients completed a 3- month follow up questionnaire and of these, 65 insomniac and 59 control patients completed the 6- month follow up questionnaires. The results indicated that QoL improvements due to CBT can be maintained for at least 6 months, with significant differences in the domains physical functioning, limitation due to emotional problems and mental health.
Arnedt et al. (2012) compared the efficacy of a CBT intervention delivered by telephone with instructions given regarding insomnia on a pamphlet. This was done by using a randomized, controlled parallel trial. CBT delivered by telephone is way of making the CBT more accessible to more people as compared to the traditional CBT. One of the hypotheses is that patients receiving telephone-delivered CBT would show greater improvements on QoL. Measures of QoL were obtained by using the SF-12 form after treatment and at a 12 week follow-up. A total of 30 individuals who suffered from chronic insomnia participated in this study, of which 1 used OTC medications nightly and 6 used it when needed. Patients that got CBT delivered by telephone received 4 to 8 weekly sessions that lasted between 15 to 60 minutes. Results show that there was no significant main effect or interaction effect for either the MCS or the PCS on QoL.
Results from the previously presented studies regarding the effects of CBT on QoL show that similar to medications, no clear cut answer can be given regarding their effect on QoL. While some studies see positive effect due to CBT, others see no effects at all.
In this study, different studies were reviewed with the attempt to answer the questions regarding which domains of QoL are negatively affected in insomniacs when compared to good sleepers and if CBT for insomnia improves more domains of QoL compared with the use of medication for insomnia. With regards to the first research question it was found that the majority of the studies found significantly lower scores on all domains of QoL. With the exception of one study by Fornal-Paw??owska and Szelenberger (2013) that found no negative effect on QoL due to insomnia on physical health, it can be said that there is no domain of QoL that is consistently immune to the negative effects of insomnia.
Regarding the second research question, no obvious answer can be given as to which leads to more improvement in QoL.
One study by Sasai et al. (2010) shows that insomniacs that use medications score lower on QoL than those who also suffer from insomnia but do not use medications. This was the case for both MCS and PCS dimensions. Conversely, the study by Walsh et al. (2007) shows that patients who suffer from insomnia and that use pharmacological treatments score better than patients that have received placebo as a treatment. Domains that received higher scores in this study included vitality, social functioning, physical functioning and bodily pain. The study by Leger et al. (2012), indicates that insomniacs receiving pharmacological treatment score better than those not receiving any treatment on all the MCS components, while no significant difference were found for PCS. Scalo et al. (2013) compared use of pharmacological therapy over time and it was found that there was no difference in neither of the component summaries due to pharmacology. In conclusion, there seems to be negative effects, positive effects as well as no effects on QoL due to pharmacology.
Regarding the efficacy of non-pharmacological treatments for insomnia, two studies , formal-Paw??owska and Szelenberger (2013) and Tomeny et al. (2006), show increase in certain domains of QoL, such as vitality, social functioning, mental health, physical functioning and role limitations due to emotional problems over a period of time. However, results of Omvik et al. (2006) and Arnedt et al. (2012) where non-pharmacological treatments were evaluated, no significant difference was found. This was for both the PCS and MCS of insomnia sufferers who used non-pharmacological treatments over a period of 12-months and 6 month follow-ups, respectively. In conclusion, it was found that either no domain was positively affected by CBT or only a few were positively affected. This finding is almost the same as that of pharmacological treatment except for the fact that no study assessing CBT has found negative effect on QoL.
It is interesting for future research to explore what the factors are besides treatment that may help towards an improvement in QoL of insomniacs. For example, if CBT is most effective in people who have been suffering from insomnia less than one year, or if medication is more effective in females than in males. The relevance of this question lies in the fact that if a person reports low level of a specific domain of QoL and is also suffering from insomnia, this person must be given a treatment that will fulfill his needs as best as possible. Thus, this person must be given a treatment which will help with his insomnia symptoms as well as improve the specific domain of QoL that is decreased. Furthermore, as the use of pharmacological therapy seems to be relatively safe for a period of 6 to 12 months (Bhat, et al., 2008) and CBT has showed to have very low risks and also post-treatment improvements that last for up to 2 years (vitello, et al. 2013), the need for improvement of CBT so that it can positively affect all domains of QoL is apparent.
One possible limitation of this study is that there were studies in which no information was given regarding which pharmacological treatments were used by chronic insomniacs. This means that groups of insomnia patients that used medication could have consisted of patients who use medications with the severe side effects and patients who used medications that had fewer side effects. Therefore, if these patients were put in the same group their scores on QoL could show an average effect (Leger, et al., 2012).
From above mentioned results, it seems that the negative impact of untreated insomnia on all domains of QoL is certain. However, when improvement in QoL of insomnia sufferers by treatments is the variable of interest, there does not seem to be consistency regarding the different domains of QoL. While one study can show that medications improve QoL, another can show that it leads to further impairment of QoL. Similarly, while one study can show improvement brought about by CBT in QoL, another may show no significant improvement at all. Finally, Vitality, social functioning and physical functioning are the domains that were significantly better in all the studies that found a positive effect of CBT or medication on QoL.