Introduction
Insomnia and other sleep disorders are amongst the most neglected illnesses by medical practitioners [
1]. The various studies that have attempted to address the prevalence of sleep disorders in the Kingdom of Saudi Arabia are limited [
2]. Nevertheless, according to the available data, it is evident that sleep disorders are increasingly becoming prevalent amongst Saudis, yet sleep medicine services in Saudi Arabia remain below the level of services offered in developed countries [
3]. A recent study reported the prevalence of insomnia with the presence of daytime dysfunction in 57% of Saudi adults attending primary care services [
1]. Various obstacles have been cited as the factors that hinder the progress of speciality in sleep medicine in Saudi Arabia. They include a lack of specialists, few trained technicians, and insufficient funding [
2]. Furthermore, awareness about insomnia and other sleep disorders as well as their consequences is low amongst healthcare authorities and practitioners [
1]. This lack of knowledge is attributed to the poor education received by medical students who transition into practice [
4]. The low awareness is also widespread amongst the general public, health care workers and authorities, and the insurance companies in Saudi Arabia [
2]. With such low awareness and knowledge about insomnia, there are no evidence-based clinical guidelines regarding the management of the illness amongst Saudis.
Overall, two treatment options have been accepted widely for the management of insomnia. These methods include cognitive behavioural therapy for insomnia (CBT-I) and hypnotic medications [
5,
6]. Comparatively, hypnotic drugs act faster than CBT-I and are thus preferred by patients [
6]. Some of the drugs used in the treatment of insomnia are benzodiazepines and Z-drugs. Despite being indicated for this disorder, benzodiazepines have the potential to trigger dependence with consequent rebound and withdrawal symptoms upon sudden discontinuation [
6]. In contrast to benzodiazepines, Z-drugs are more selective in their action and have a lower tendency to develop dependence and withdrawal symptoms [
6]. They still, however, have similar adverse effects associated with benzodiazepines as they can cause anterograde amnesia, sedation, impaired balance, and complex sleep-related behaviour [
6,
7].
Hypnotic risks and side effects have led to the development of many guidelines for diagnosing and managing chronic insomnia in different countries [
8‐
12]. Whilst benzodiazepines and Z-drugs have proven benefits in the management of primary insomnia, contradiction and differing opinions surround their use [
13]. This is because there is no clear evidence guiding the judicious use of these drug classes for the treatment of insomnia, especially in countries like Saudi Arabia where there is an overall low awareness of sleep medicine [
2]. In addition, many physicians in Saudi Arabia do not follow international guidelines because they lack awareness of them or think they are culturally inappropriate for use in Saudi Arabia [
14]. It is, therefore, imperative that Saudi Arabia has its own guidelines for treating and managing insomnia and other sleep disorders, which are consistent with its own history and culture.
Consensus methods can be used to come up with guiding principles to eliminate the barriers associated with contradictory opinions [
15]. One such approach is the Delphi technique, a structured process designed to arrive at a consensus of choice or judgement following responses by a panel of experts to rounds of questionnaires on a topic for which there is little evidence [
16,
17]. This method is particularly useful in situations where several dissenting opinions and contradictions surround a subject [
15,
16], as in the use of Z-drugs and benzodiazepines in the management of primary insomnia in Saudi Arabia. Guidelines developed by this means are likely to be accepted widely by medical practitioners in the country involved [
15].
Discussion
Clinical practice guidelines form critical frameworks for the summary and translation of continually changing evidence from research into actual practice [
19]. They assist practitioners in making reasonable clinical decisions about appropriate healthcare for specific clinical circumstances [
20,
21]. This study aimed to obtain consensus on items required for developing clinical guidelines for using benzodiazepines and Z-drugs for managing insomnia amongst adults in Saudi Arabia. After three rounds of review, the e-Delphi technique generated 16 statements to be included in future guidelines. Five statements failed to reach the 80% level of consensus needed and were, therefore, excluded from the guidelines. The e-Delphi technique was considered the most appropriate method considering the lack of national clinical guidelines currently in the Saudi healthcare literature. This method facilitated the consolidation of information from experts in several locations and omitted the burden of travelling around the country [
15,
16]. Because the researcher could provide feedback after each round, encourage participants to reflect on their answers, and assess them compared to other answers, the e-Delphi technique enhanced an interactive exchange of information between participants [
16]. The expert panel agreed that the use of benzodiazepines and/or Z-drugs for primary insomnia should be accompanied by a documented diagnosis. The panel also agreed that before initiating any intervention, it is imperative to conduct a thorough assessment of the patient to identify all the possible causes of disturbed sleep and to identify all the salient exacerbating factors so that appropriate treatment is indicated as necessary [
22]. The panel also came to the consensus that CBT-I is useful and recommended as a first-line treatment for primary insomnia. The management of primary insomnia amongst the adult population in Saudi Arabia should centre, at least initially, on cognitive and behavioural non-pharmacological approaches. These strategies include sleep hygiene, straightforward advice, relaxation techniques, counselling, and behavioural therapy [
8]. Behavioural and psychological interventions have been proven to be useful for all adults as well as for chronic users of hypnotic drugs [
8]. When the initial behavioural or psychological treatment proves ineffective, other approaches should be considered and the patient evaluated for potential occult comorbidities [
11].
Thus, the expert consensus is that pharmacological interventions should be considered when non-pharmacological treatments were unsuccessful and alternated from one class to the other only if they prove unsuccessful. Importantly, the choice of benzodiazepines or Z-drugs should be guided by the treatment goal, symptomatology, patient preference, past response patterns, cost, comorbidities, interactions with concomitantly administered medications, side effects, contraindications, and the availability of other treatment options [
11]. Although short- to intermediate-acting benzodiazepines or Z-drugs are recommended for adults with primary insomnia [
6,
11], all of the expert opinions reviewed by the study emphasised that these drugs should be used for short-term use only.
Due to dependency and tolerance associated with most hypnotic medications, the panel recommended a maximum treatment duration of 2 weeks. Repeat or additional prescriptions for benzodiazepines or Z-drugs should be avoided because their long-term use can complicate prognoses [
22]. Furthermore, it was agreed that dosage tapering should be considered for patients withdrawing from these drugs and that CBT-I is known to be effective in helping medication tapering and discontinuation [
11].
The e-Delphi technique further revealed that all the experts involved were of the opinion that when prescribing benzodiazepines and Z-drugs beyond the maximum treatment period, reasons for continuing should be documented. Long-term hypnotic therapy may be indicated for individuals with refractory or severe insomnia or persons with chronic comorbidities [
11]. Consistent follow-up, however, is imperative, preferably every 4–6 weeks in the initial phase of treatment, to assess potential side effects, treatment efficacy, and the reason for continuing the medication [
11]. The prescriber should always ensure that hypnotic medications are reviewed regularly and all review dates and relevant advice are clearly documented in the patient’s records [
22].
The panel was unanimous that alternative medicines should be used if the prescribed benzodiazepines or Z-drugs are deemed to be ineffective. Drugs from other classes are available to treat primary insomnia, but unlike benzodiazepines and Z-drugs, they work through receptors other than the benzodiazepine section of the gamma-aminobutyric acid (GABA-A) receptor [
6]. Additionally, the experts agreed that patients should be informed that using benzodiazepines or Z-drugs is for a limited duration only. Patient education should always accompany treatment, particularly if benzodiazepines and Z-drugs are prescribed. Amongst the many factors that patients should be informed about are safety concerns, treatment expectations and goals, potential drug interactions and side effects, alternative treatment modalities including behavioural and cognitive therapy, rebound insomnia, and the possibility for dosage increments [
11].
Over 90% of the responses given recommended that extension beyond the maximum treatment period for benzodiazepines or Z-drugs should not take place without re-evaluation of the patient and that short-term hypnotic treatment should be supplemented with CBT-I when possible. Furthermore, patients should be advised to keep sleep diaries and that, should a relapse occur, the data be used for long-term re-evaluation [
11]. In addition to clinical reassessment of patients, regular administration of survey tools, such as questionnaires, might be useful in outcome assessment. Findings from such tools would help in informing subsequent treatment efforts [
11].
Most experts consider sleep hygiene a useful treatment modality and recommend it as a first-line treatment for insomnia. Even though insomnia patients should follow sleep hygiene recommendations, there is insufficient evidence to support the effectiveness of sleep hygiene alone for managing chronic primary insomnia [
11]. For this reason, sleep hygiene should be combined with other interventions, such as biofeedback therapy (educating patients to control involuntary processes in their body such as muscle tension and blood pressure) [
11].
Even though short-acting benzodiazepines or Z-drugs are recommended as the first-line pharmacological treatment for primary insomnia [
11], the majority of participants rejected this recommendation to be included in the guidelines. A significant number of experts believed that benzodiazepines and Z-drugs should be used to treat primary insomnia only when it is severe, disabling, or causing extreme distress. A majority of the panellists also recommended prescribing these drugs in the first instance at the lowest effective dose. This dose should be used for maintenance and tapered off as determined by the prognosis [
11]. Further, the specialists said that benzodiazepines or Z-drugs should not be prescribed for more than 4 weeks as recommended in the literature [
23], and that switching from one hypnotic to another should be considered only if the patient experiences adverse effects from the drug they are using [
22]. Importantly, most of the responders agreed that benzodiazepines should not be prescribed to known or suspected users of illicit drugs. According to the literature, exceptions may be made if the drugs are indicated as part of an opiate detoxification programme or prescribed under close monitoring and supervision by psychiatrists on an acute basis [
22].
Overall, a consensus was reached for most of the recommendations with significant agreements between rounds. The e-Delphi technique was well received and external reviewers contributed extensive comments to support the development of guidelines. Although the authors believe that the contributions from the medical experts to the consensus statements are thoughtful and valuable, this study has some limitations. The absence of a face-to-face meeting might have deprived experts from exchanging important information, such as clarification of reasons for disagreements [
24,
25].
Conclusion
With little awareness about sleep disorders and the absence of evidence-based clinical guidelines on the management of insomnia, adults in the Saudi Arabia are at a higher risk of suffering serious consequences from the condition. It is imperative, therefore, that effective guidelines for treating insomnia and sleep disorders are developed in Saudi Arabia, particularly guidelines concerning the pharmacological management of primary insomnia with benzodiazepines and Z-drugs. Using the e-Delphi technique, this study developed evidence-based expert clinical opinions for using benzodiazepines and Z-drugs in managing insomnia, and such findings based on consensus statements, together with insomnia advocacy, reviewing service delivery across Saudi Arabia, and best-practice management of primary insomnia, can lead to optimal sleep disorder healthcare in Saudi Arabia.
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