Thursday, July 07, 2016

Are the "Sleep Disturbing" Pills You Are Taking Actually Worsening Your Sleep?

Do patients with intake of drugs labelled as sleep 

disturbing really sleep worse? A population 

based assessment from the Heinz Nixdorf Recall Study.

  1. Anna-Therese Lehnich1,*
  2. Bernd Kowall1,
  3. Oliver Kuß2
  4. Andrea Schmidt-Pokrzywniak3
  5. Gerhard Weinreich4
  6. Nico Dragano5,
  7. Susanne Moebus1
  8. Raimund Erbel1
  9. Karl-Heinz Jöckel1 and
  10. Andreas Stang1,6
DOI: 10.1111/bcp.13015
Abstract from study discussing the efficacy of the claim that drugs labelled as "sleep disturbing" actually worsen sleep. -JR


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


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 4,221 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.
Do patients with intake of drugs labelled as sleep disturbing really sleep worse? A population based assessment from the Heinz Nixdorf Recall Study. (n.d.). Retrieved June 20, 2016, from

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