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Br J Clin Pharmacol. 2016 Sep;82(3):869-77. doi: 10.1111/bcp.13015. Epub 2016 Jun 23.

Do patients with intake of drugs labelled as sleep disturbing really sleep worse? A population based assessment from the Heinz Nixdorf Recall Study.

Author information

Institute of Medical Informatics, Biometry and Epidemiology Medical Faculty, University of Duisburg-Essen, Essen.
Institute for Biometrics and Epidemiology, German Diabetes Center, Leibniz Institute for Diabetes Research at Heinrich Heine University, Düsseldorf.
Institute of Medical Epidemiology, Biostatistics and Informatics, Martin-Luther-University Halle-Wittenberg, Halle.
Department of Pneumology, Ruhrlandklinik, West German Lung Centre, University Hospital of Essen, University of Duisburg-Essen, Essen.
Institute for Medical Sociology, Centre for Health and Society, University of Düsseldorf, Medical Faculty, University of Düsseldorf, Düsseldorf, Germany.
Department of Epidemiology, Boston University, School of Public Health, MA, Boston, USA.



The sleep disturbing effect of many drugs is derived from clinical trials with highly selected patient collectives. However, the generalizability of such findings to the general population is questionable. Our aim was to assess the association between intake of drugs labelled as sleep disturbing and self-reported nocturnal sleep disturbances in a population-based study.


We used data of 4221 participants (50.0% male) aged 45 to 75 years from the baseline examination of the Heinz Nixdorf Recall Study in Germany. The interview provided information on difficulties falling asleep, difficulties maintaining sleep and early morning arousal. We used the summary of product characteristics (SPC) for each drug taken and assigned the probability of sleep disturbances. Thereafter, we calculated cumulative probabilities of sleep disturbances per subject to account for polypharmacy. We estimated prevalence ratios (PR) using log Poisson regression models with robust variance.


The adjusted PRs of any regular nocturnal sleep disorder per additional sleep disturbing drug were 1.01 (95% confidence interval (CI) 0.97, 1.06) and 1.03 (95% CI 1.00, 1.07) for men and women, respectively. Estimates for each regular nocturnal sleep disturbance were similarly close to 1. PRs for regular nocturnal sleep disturbances did not increase with rising cumulative probability for drug-related sleep disturbances.


SPC-based probabilities of drug-related sleep disturbances showed barely any association with self-reported regular nocturnal sleep disturbances. We conclude that SPC-based probability information may lack generalizability to the general population or may be of limited data quality.


adverse drug reaction; drug intake; sleep disturbances; summary of product characteristics

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