Most people don't sleep any worse when taking medicines with sleep disturbance warnings

June 08, 2016

Medicines that carry warnings about sleep disturbances do not seem to contribute to the amount of sleep disturbances in the general population, according to new 'real world' research. The findings, which are published in the British Journal of Clinical Pharmacology suggest that investigators may need to provide more careful reporting of side effects in clinical trials, and emphasizes the value of research into the safety of medicines once they are being taken by the general population.

Sleep disturbances and their consequences can have considerable impacts on health. Drugs are labeled as sleep disturbing in patient information leaflets due to findings from clinical trials, but it's unclear whether these drugs actually lead to more sleep disorders--such as difficulties falling or staying asleep, or waking in the early morning -- in the general population. To investigate Anna-Therese Lehnich, of the University of Duisburg-Essen in Germany, and her colleagues analyzed information on 4,221 individuals aged 45 to 75 years.

Interviews revealed no clear links between drugs labeled as sleep disturbing with actual experiences of problems related to sleep. "We found that drugs labeled as sleep disturbing do not contribute strongly to the high frequency of sleep disturbances in the general population. Moreover, the intake of several sleep disturbing drugs at the same time barely led to more sleep disturbances at night," said Lehnich. "Surprisingly, we could not show that the frequency categories -- 'uncommon,' 'common,' and 'very common' -- for the occurrence of sleep disturbances from patient information leaflets result in different frequencies of sleep disturbances."
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Full citation: "Do patients with intake of drugs labelled as sleep disturbing really sleep worse? A population based assessment from the Heinz Nixdorf Recall Study." Anna-Therese Lehnich, Bernd Kowall, Oliver Kuß, Andrea Schmidt-Pokrzywniak, Gerhard Weinreich, Nico Dragano, Susanne Moebus, Raimund Erbel, Karl-Heinz Jöckel, and Andreas Stang. British Journal of Clinical Pharmacology. Published Online: June 9, 2016, DOI: 10.1111/bcp.13015

URL Upon Publication: http://doi.wiley.com/10.1111/bcp.13015

Author Contact:

To arrange an interview with the author, Christine Harell, of the University of Duisburg-Essen's communications office, at christine.harrell@uk-essen.de.

About the Journal

The British Journal of Clinical Pharmacology has the primary goal of publishing high quality research papers on all aspects of drug action in humans. The journal has a wide readership, bridging the medical profession, clinical research and the pharmaceutical industry, and is published monthly. It is owned by the British Pharmacological Society and published by Wiley. The journal's current Impact Factor is 3.878, its highest ever (Thomson Reuters Science Citation Index).

About The British Pharmacological Society

The British Pharmacological Society is a charity with a mission to promote and advance the whole spectrum of pharmacology. Founded in 1931, it is now a global community at the heart of pharmacology, with over 3,500 members from more than 60 countries worldwide. The Society leads the way in the research and application of pharmacology around the world through its scientific meetings, educational resources and peer-reviewed journals: the British Journal of Clinical Pharmacology, Pharmacology Research & Perspectives and the British Journal of Pharmacology, which includes the Concise Guide to PHARMACOLOGY, featuring open access overviews of the key properties of over 1,700 human therapeutic targets and their drugs, and links to http://www.guidetopharmacology.org.

Press Office: +44 20 7239 0180 | M. +44 7786 552498 | E. sophia.griffiths@bps.ac.uk

About Wiley

Wiley is a global provider of knowledge and knowledge-enabled services that improve outcomes in areas of research, professional practice and education. Through the Research segment, the Company provides digital and print scientific, technical, medical, and scholarly journals, reference works, books, database services, and advertising. The Professional Development segment provides digital and print books, online assessment and training services, and test prep and certification. In Education, Wiley provides education solutions including online program management services for higher education institutions and course management tools for instructors and students, as well as print and digital content. The Company's website can be accessed at http://www.wiley.com.

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