The Pharmaceuticalisation of Sleep and Wakefulness: A Social Scientific Investigation of Stakeholder Interests, Policies and Practices

Lead Research Organisation: University of Warwick
Department Name: Sociology

Abstract

Abstracts are not currently available in GtR for all funded research. This is normally because the abstract was not required at the time of proposal submission, but may be because it included sensitive information such as personal details.

Publications

10 25 50
 
Description 1. Pharmaceuticalisation - the transformation of human conditions, capabilities and capacities into opportunities for pharmaceutical intervention.

Analysis across our data sets shows an uneven pharmaceuticalisation of the sleep-wake cycle. Substantially more hypnotics are prescribed in England (remaining stable at around 10 million since 2000) than wakefulness promoting drugs.

Focus group data on the use of sleep/wakefulness medicines revealed evidence of patient/consumer resistance to pharmaceuticalisation. For example, some respondents (mainly non-users or ex-users of sleeping pills) rejected pharmaceuticals for sleep problems and preferred non-pharmacological therapies. Likewise, we found a general resistance to social uses of wakefulness promoting pharmaceuticals.

Other respondents however provided support for pharmaceuticalisation by presenting themselves as deserving of pharmaceuticals, questioning medical authority when doctors suggested coming off them and, on occasion, seeking prescription drugs outside the medical encounter. The later evidence provides a challenge to the current depharmaceuticalisation of sleep agenda.

Documented cases of depharmaceuticalisation of sleep are rare. The process is thus best seen as fluid, particularly given recent CBTi-based interventions, although doctors and other sleep experts do not necessarily see CBTi as an alternative to medication. On this basis we conclude that the degree to which sleep problems are subject to (de)pharmaceuticalisation in the future remains uncertain.

2. Developments in sleep-promoting medications.

Drug development of hypnotics has been slow with the European Medicines Agency (EMA) approving only two, Sonata (zapelon) and Circadin (melatonin) since 1999. The pharmaceutical industry's innovation strategy has been conservative, designed primarily to limit the adverse effects of benzodiazepines through marketing more Z drugs (Zopiclone, Zolpidem and Zaleplon). However, according to the National Institute for Health and Care Excellence (NICE), Z drugs have no clinical advantages over benzodiazepines (e.g. in reducing dependence). Concurrently, there has been little attempt to address long- term insomnia, with the possible exception of Circadian, licenced for use up to 13 weeks, though chronic insomnia can last much longer.

The regulatory system also discourages innovative drug development which could meet the challenge of long term insomnia. When innovations like Circadin are assessed for efficacy in clinical trials this is often based solely on comparisons with placebo, rather than with existing hypnotics.

3. The challenges for sleep promoting drugs.

A key challenge for pharmaceutical companies, given their stated aim of drug innovation, is the development of efficacious hypnotics for chronic insomnia without risk of dependence. This requires a decisive shift away from an innovation strategy based on marketing for the overuse of benzodiazepines and z-drugs. Crucial in achieving this are regulators who set the context in which the industry operates. Regulators should require new hypnotics to be compared with existing sleeping pills in clinical trials and demonstrate therapeutic advance. NICE needs to be more pro-active in encouraging cost-effective prescribing and the Government needs to take the problem of chronic insomnia more seriously by backing public health initiatives on how best to tackle this condition as part of a wider attempt to promote the sleep of the nation. Patient organisations too can lobby for access to new/existing medications and non-pharmacological alternatives.
Exploitation Route Non-academic

(a) Patient organizations

• To press pharmaceutical companies to adopt innovation strategies to tackle the unmet need of treatment for chronic insomnia.
• To lobby for improved access to valued but difficult to obtain drugs (e.g. Narcolepsy UK and access to sodium oxybate).

(b) Expert advisers to regulatory agencies and senior medical professionals

• To press regulators to require pharmaceutical companies to conduct active-controlled trials of hypnotics. Doctors would have better knowledge of the comparative efficacy of the drug therapies available, rather than relying on the promotional claims of industry.
• To shift the industry business model from investing in promotion to researching innovations offering therapeutic advance.

(c) NICE and other expert advisors (e.g. The Office of Fair Trading)

• NICE needs to look again at the cost-effectiveness of hypnotics, with a wider remit that investigates pricing policy and regulation.

(d) Sleep scientists, GPs and patients

• To enhance understanding of sleep medications through awareness of each actor's perspective
• To develop guidelines for insomnia management in primary and secondary care.

Academic

Academics working in the interdisciplinary, interrelated areas of pharmaceuticals and society, and sleep and society, with particular reference to debates about pharmaceuticalisation of sleep and wakefulness in the twenty-first century.
Sectors Healthcare,Government, Democracy and Justice,Pharmaceuticals and Medical Biotechnology

URL http://www2.warwick.ac.uk/fac/soc/sociology/research/currentresearch/sleep/casestudies/
 
Description We have tried to maximize societal impact by engaging in a series events with different publics. For example we have given talks to the British Science Festival and the British Sleep Society Annual Scientific Meeting to raise awareness of the sociological issues around sleep and sleep medicines. The former talk provided an opportunity to debate these issues with the general public while the latter involved discussions with clinicians and sleep scientists. Feedback suggested that we had enhanced people's understanding of these issues. At the BSF we meet a number of journalists who were interested in our presentation and this lead to our work being reported in the Financial Times ('Pharmacology: Sleeping pills - dream or nightmare' by Clive Cookson and Tyler Shendruk, Financial Times 22/9/14). We also talked about our research at a dissemination event held at Warwick university and attended by study participants, clinicians, sleep scientists, representatives from the voluntary sector and students. In a further attempt to reach primary care clinicians we provided copy for a newsletter aimed at these clinicians. And we also wrote a piece for the online magazine Discover Society to engage with as wide an audience as possible. Finally we have been liaising with a representative from the voluntary sector organisation Oldham Tranx who in turn is putting us in touch with the All Party Parliamentary Group for Prescribed Drug Dependence. We hope to enhance the impact of our research by engaging with this group.
First Year Of Impact 2014
Sector Healthcare,Pharmaceuticals and Medical Biotechnology
Impact Types Societal,Policy & public services

 
Description Preliminary Report to Narcolepsy UK
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
URL http://www2.warwick.ac.uk/fac/soc/sociology/research/currentresearch/sleep/narcolepsy_report_feb_201...
 
Description Report of research findings to Sleep Apnoea Trust Association
Geographic Reach National 
Policy Influence Type Influenced training of practitioners or researchers
URL http://www2.warwick.ac.uk/fac/soc/sociology/research/currentresearch/sleep/sleep_project_sleep_apnoe...
 
Description Report to West Midlands Ambulance Service
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Influenced training of practitioners or researchers
URL http://www2.warwick.ac.uk/fac/soc/sociology/research/currentresearch/sleep/sleep_project_wmas_report...
 
Description Sleep, health and wellbeing, NICE Topic Advisory workshop
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
 
Description 'Sleep, Medicines and Society' user/public engagement day-long event hosted at Warwick University 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Study participants or study members
Results and Impact An opening talk by me on 'The Sleep of the Nation' as part of our 'Sleep, Medicines and Society' user group/public engagement event hosted at the University of Warwick (5th November 2014) based on our ESRC Pharmaceuticalisation of Sleep and Wakefulness' project. This day long event involved a range of presentations from our project, in the morning and afternoon, with discussants for each paper and further questions from discussion from our participants and attendees.
Year(s) Of Engagement Activity 2014
URL http://www2.warwick.ac.uk/fac/soc/sociology/research/currentresearch/sleep/sleepmedicinesandsociety/
 
Description Article in Discover Society - The sleep of the nation: problems and prospects 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other audiences
Results and Impact Article in the on line magazine Discover Society which reported the results of our study in the context of a general discussion about the sociological aspects of sleep problems and prospects for public health
Year(s) Of Engagement Activity 2014
URL http://discoversociety.org/2014/08/05/the-sleep-of-the-nation-problems-and-prospects/
 
Description Interview for news-medical.net 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact On line Interview stemming from a talk given by a member of the research team (Dr Catherine Coveney) on 'the pharmaceuticalization of today's sleep' to the Royal Society of Medicine Sleep Section meeting on 7 February 2017. Stimulated increased interest in the research
Year(s) Of Engagement Activity 2017
URL http://www.news-medical.net/news/20170404/Pharmaceuticalisation-of-todaye28099s-sleep.aspx
 
Description Lecture to Royal Society of Medicine Sleep Medicine Section 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Talk on 'The pharmaceuticalisation of today's sleep: A sociological perspective' as part of a symposium on 'Is today's society sleep deprived?' 50 People attended and the talk generated questions and discussion. One journalist has requested an interview
Year(s) Of Engagement Activity 2017
URL https://www.rsm.ac.uk/events/events-listing/2016-2017/sections/sleep-medicine-section/slh02-is-today...
 
Description Presidential session at the British Science Festival in Birmingham 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Talk sparked general questions and interested parties stayed behind afterwards for further discussion

Resulted in media coverage in the Financial Times
Year(s) Of Engagement Activity 2014
URL http://www.britishscienceassociation.org/british-science-festival/sleep-drugs-and-24-hour-living
 
Description Sleep, Medicines and Society dissemination event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Study participants or study members
Results and Impact We gave 6 talks followed by an open discussion. The open discussion involved a panel, made up of clinicians, and the chair of a voluntary organisation. The talks sparked questions and discussion and these were revisited in the open discussion at the end. Part of the open discussion involved talking specifically about impact

One notable impact is that a representative of the local general practice research network is going to write a summary of the research findings reported on the day to be circulated to all general practitioners in the region
Year(s) Of Engagement Activity 2014
URL http://www2.warwick.ac.uk/fac/soc/sociology/research/currentresearch/sleep/sleepmedicinesandsociety/
 
Description Special session for British Sleep Society annual scientific meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Organised a session on 'Sociological Aspects of Sleep Medicine and its Treatment' to sleep scientists and clinicians and social scientists (researchers, lecturers and postgraduate students) at the 23rd Annual Conference of the British Sleep Society, Cambridge University. Two of the research team gave presentations - Prof John Abraham on 'Sleeping pills, the pharmaceutical industry and medicines regulation' and Research Fellow Dr Catherine Coveney on ' From therapy to enhancement: Exploring the prospective use of modafinil outside the clinic'. It was chaired by the PI - Prof Jonathan Gabe. The purpose was to try and engage specifically with sleep scientists and clinicians. The session resulted in a lively discussion with members of the audience and broadened the debate to include social factors involved in sleep and its management.
Year(s) Of Engagement Activity 2011
URL http://www.artp.org.uk/en/courses/all-courses.cfm/BSS_23rd_Annual_Scientific_Meeting
 
Description report of research in Participate West Midlands South Primary Care Research News letter 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Our research on `medicated sleep' which was presented at our feedback event at Warwick University was subsequently reported in the West Midlands South Primary Care Research Newsletter, vol 16, Winter 2014. This newsletter is read by GPs, practice nurses and other members of the primary care team in West Midlands South. Study participants (GPs) who did not attend the feedback event, along with other readers of the newsletter, therefore had an opportunity to reflect on the implications of our findings for practice
Year(s) Of Engagement Activity 2014
URL http://www2.warwick.ac.uk/fac/med/about/centres/crn-primarycare/newsletters/5856_uow_participate_-_w...