An updated European Insomnia Guideline was recently published in Journal of Sleep Research by a group of clinicians and researchers from the European Sleep Research Society (ESRS) and the European Insomnia Network. This 2023 update builds upon several points of the original 2017 guideline, which World Sleep Society (WSS) endorsed in early 2021.
World Sleep Society regularly publishes position papers and endorsements of sleep medicine guidelines, reviewing their applicability for the international membership of WSS. While explicitly not a formal endorsement or a “re-endorsement,” this post offers some commentary on the 2023 updates, considering them alongside the WSS endorsement of the original 2017 guideline.
In essence, what is new in the updated 2023 European guideline for the diagnosis and treatment of insomnia, and how might that relate to the WSS endorsement of the original 2017 guideline? Find some take-aways summarized below.
We encourage WSS members to review the full text of “The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023,” which is freely available at https://onlinelibrary.wiley.com/doi/10.1111/jsr.14035
Take-away 1: CBT-I remains the recommended first-line therapy for chronic insomnia disorder in adults of any age.
This was evaluated to be a “very strong recommendation” under the grades of recommendation used by the authors of the 2023 guideline update. This remains consistent with the strong recommendation by WSS described in the 2021 endorsement.
Take-away 2: CBT-I may be delivered either in person or digitally.
This was evaluated to be a “very strong recommendation” in the 2023 guideline update. This is a significant update because the recommendation includes the option of digital CBT-I.
Digital CBT-I is a fast developing therapy and was given only brief consideration in the original 2017 guideline and no specific comment in the 2021 WSS endorsement.
Information on digital CBT-I has been considerably expanded within the 2023 guideline update, including more recent meta-analyses on its efficacy, existing treatment programs with scientific evidence, and a set of criteria with which to assess digital therapeutics (Espie, Torous & Brennan 2022).
While digital CBT-I may help to address the main caveat of the WSS endorsement that “there are few clinicians with adequate expertise to deliver this treatment compared to the large burden of disease,” continued research into digital CBT-I is imperative to evaluate its effectiveness compared to in-person therapy. Questions of access to evidence-based digital CBT-I programs may persist among WSS membership as the support by local/national health authorities will vary.
While ostensibly therapeutic digital programs and apps proliferate, WSS members are encouraged to consider the WHAT criteria described in the 2023 European insomnia guideline and developed by Espie, Torous, and Brennan (2022). These criteria direct you to consider the evidence base, accessibility/usability, and trustworthiness of a digital therapeutic.
According to Dr. Espie, “Digital CBT is no different from any other treatment – it needs to be evidence-based. The WHAT criteria are there to provide guidance on minimal standards for people developing interventions for the clinical space.
We can’t tolerate ‘special pleading’ from app developers that clinical trials are expensive, time-consuming, or even some might say unnecessary. I have often heard that developers just want to help people (quickly), but there is distraction and likely harm from enthusiasms. Science takes an evidence-based approach and is sceptical of strongly held beliefs. Our patients with insomnia need and deserve treatments that work.”
Take-away 3: Dual orexin receptor antagonists (DORAs) are a new therapy considered in the 2023 guideline update and considered by its authors “the most significant recent development in the pharmacological treatment of insomnia.”
Assuming that CBT-I is not effective, the updated European insomnia guideline newly issues a “very strong recommendation” that orexin receptor antagonists can be used for a period of up to 3 months in the treatment of insomnia. Longer-term treatment with orexin receptor antagonists may be considered in some cases, but advantages and disadvantages need to be weighed alongside the patient (also a “very strong recommendation”).
The 2023 guideline update considered only one DORA currently available in Europe: daridorexant. This only recently became available for use in Europe, the United States, and Canada, so daridorexant was not considered within the original guideline and its subsequent endorsement by WSS.
Daridorexant has been approved by the European Medicines Agency on the basis of two controlled phase-III studies. Given its novelty to real-world application in Europe, the authors of the 2023 European insomnia guideline still advise caution while real-world data and experiences are gathered by treatment providers.
Accessibility may remain a concern for WSS membership, particularly those outside of the United States, Canada, and European Union. The 2021 guideline endorsement includes a list of pharmacological options more widely available and well studied; those recommended in the WSS endorsement with high-quality evidence include benzodiazepines (e.g., nitrazepam, flurazepam) and GABA-A agonists (e.g., zolpidem, zopiclone) – but note that the recommendation applies only to short-term treatment (≤4 weeks).
Updated Practice Recommendations from World Sleep Society
The Practice Recommendations committee will be updating its earlier endorsement to account for the latest European insomnia guideline. World Sleep Society’s updated endorsement will provide further commentary on the details of the European insomnia guideline, analyzing it for details of clinical relevance to our members across different global contexts. Stay in touch with World Sleep Society for more updates on practice recommendations in sleep and circadian medicine!