15 July 2022
- Which is the best, current pharmacological treatment for insomnia?
- What are the acute and long-term effects of medications to treat insomnia?
Two drugs, eszopiclone and lemborexant – both not currently licenced for the treatment of insomnia in the UK – were shown to perform better than others, both in the acute and long-term treatment of insomnia in adults, according to a new Oxford study exploring the pharmacological management of insomnia.
This new study, published in The Lancet, and funded by the NIHR Oxford Health Biomedical Research Centre, is the largest of its kind to date, involving 154 double-blind trials including 44,000 people randomised to one of 30 licensed or not licensed drugs, or placebo.
The new network meta-analysis, led by Professor Andrea Cipriani, sought to estimate the comparative effectiveness of pharmacological treatments for the acute and long-term treatment of adults with insomnia disorder, where the condition is not accompanied by a mental health co-morbidity, such as depression or physical illness. Study participants were assessed on their quality of sleep, the effects of treatment discontinuation, and the presence of any adverse events, such as dizziness, nausea, fatigue, headache, sedation and somnolence (feeling drowsy).
Insomnia is defined as dissatisfaction with sleep quantity or quality, and is associated with at least three months of difficulty getting to or staying asleep. It affects up to 20% of the population and for a high proportion of these people it can last for a number of years.
Andrea Cipriani, Professor of Psychiatry at the University of Oxford and honorary consultant psychiatrist at Oxford Health NHS Foundation Trust, said:
‘We hope our analysis will be of great help to clinicians seeking the most appropriate treatment for their patients. We looked at all information published and unpublished – in journals and in online registries – to achieve the most transparent and comprehensive picture of all the data available. Clearly, the need to treat insomnia as effectively as possible is very important, as it can have knock-on effects for a patient’s health, their home lives and the wider health system.
‘This study of pharmacological treatments is not a recommendation that drugs should always be used as the first line of support to treat insomnia, not least because some of them can have serious side effects. However, our research shows that some of these drugs can also be effective, and should be used in clinical practice, when appropriate. For example, where treatments such as improved sleep hygiene and Cognitive Behavioural Therapy have not worked, or where a patient wants to consider taking medication as part of their treatment.’
Although the study identified that eszopiclone could be effective as a treatment for insomnia, it may also cause substantial adverse events, such as dizziness and nausea, and safety data on lemborexant were inconclusive (but did show higher risk of causing headaches). Other findings suggest that there was insufficient evidence to support the prescription of benzodiazepines and zolpidem in the long-term treatment for insomnia.
Philip Cowen, Professor of Psychopharmacology in the University of Oxford and co-author of the paper, said:
‘It should also be noted that the drug lemborexant acted via a different pathway in the brain (the orexin neurotransmitter system), a relatively novel mechanism of action. More selective targeting of this pathway and orexin receptors could lead to better pharmacological treatments for insomnia.’
The validity of the study’s results should be tempered by the potential limitations of the current analysis. For instance, it is widely known that people tend to have problems over a long period of time, and unfortunately there were only eight studies looking at the long-term in this meta-analysis.
This research is funded by the NIHR Oxford Health Biomedical Research Centre. The NIHR is the research partner of the NHS, public health and social care.
Notes to Editor:
- The new paper, Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00878-9/fulltext
- Oxford Health NHS Foundation Trust (OHFT) provides physical, mental health and social care for people of all ages across Oxfordshire, Buckinghamshire, Swindon, Wiltshire, Bath and North East Somerset. Our services are delivered at community bases, hospitals, clinics and people’s homes. We focus on delivering care as close to home as possible.
As a leading teaching, training and research trust, we have close links to Oxford and Oxford Brookes, Buckinghamshire, Reading and Bath universities. We are part of the Oxford Academic Health Science Centre, working closely with our university colleagues to translate their findings into clinical care as quickly as possible, enabling people using our services to benefit from the latest advances in healthcare. We host the NIHR Oxford Health Biomedical Research Centre with Oxford University, and aim to bring the best science to the complex problems of mental disorders and dementia. We also host the NIHR Applied Research Collaboration Oxford and Thames Valley; a partnership between universities, healthcare, charities and industry, that aims, through applied health research, to co-produce better, more equitable, appropriate and sustainable health and care across the region. www.oxfordhealth.nhs.uk
- National Institute for Health and Care Research (NIHR)
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
- The NIHR Oxford Health Biomedical Research Centre is a partnership between Oxford Health NHS Foundation Trust and the University of Oxford.
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