14 Jun Drugs Labeled as ‘Sleep Disturbing’ May Not Contribute to Significant Sleep Disruption

MedicalResearch.com Interview with:

Anna Therese Lehnich

Anna-Therese Lehnich
Zentrum für Klinische Epidemiologie (ZKE)
c/o Institut für Medizinische Informatik
Biometrie undEpidemiologie (IMIBE)

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Sleep disturbances and their consequences are often underestimated but they are of high importance with respect to public health. We were interested in the question whether drugs labeled as sleep disturbing in the summary of product characteristics actually lead to more sleep disorders like difficulties falling asleep, difficulties maintaining sleep, and early morning arousal. To answer this question, we analyzed data of 4,221 persons from Germany.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: 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. Surprisingly, we could not show that the frequency categories for the occurrence of sleep disturbances from summary of product characteristics“uncommon”, “common” and “very common” result in gradually more sleep disturbances.

MedicalResearch.com: What should readers take away from your report?

Response: We found that drugs labeled as sleep disturbing in summary of product characteristics are not a mayor risk factor for 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. However, the individual or a specific patient can still suffer from sleep disturbances caused by drugs especially drugs against diseases of the central nervous system.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: The generalizability of SPC information on adverse drug reactions to the general population needs ongoing research, especially with respect to other more severe adverse drug reactions. Patients may stop their drug therapy if serious adverse drug reactions are said to be common with this drug. Hence, with respect to drug safety and adherence, the information given in summary of product characteristics should be applicable to the relevant groups of patients.

MedicalResearch.com: Is there anything else you would like to add?

Response: Even though drugs might not be responsible for the high frequency of sleep disturbances in the general population, the individual or a specific patient can still suffer from sleep disturbances caused by drugs. It is of mayor importance that physicians report adverse drug reactions to the competent authorities as it improves drug safety. Consequently, knowledge about drugs and their adverse drug reactions can be raised and patients and physicians have more confidence in drug therapies.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

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 Lehnich1,*, Bernd Kowall1,Oliver Kuß2, Andrea Schmidt-Pokrzywniak3,Gerhard Weinreich4, Nico Dragano5,Susanne Moebus1, Raimund Erbel1, Karl-Heinz Jöckel1 and Andreas Stang1,6
Pharmacoepidemiology
DOI: 10.1111/bcp.13015

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Last Updated on June 15, 2016 by Marie Benz MD FAAD