People that take medicines carrying warnings about sleep disturbances do not sleep any worse as a result of the medication, according to a study in the British Journal of Clinical Pharmacology
The ‘real world’ study, by the University of Duisburg-Essen, suggests that investigators may need to provide more careful reporting of side effects in clinical trials and emphasises the value of research into the safety of medicines once they are being taken by the general population.
Drugs are labeled as sleep disturbing in patient information leaflets due to findings from clinical trials, but according to the University of Duisburg-Essen it’s unclear whether these drugs actually lead to more sleep disorders in the general population.
To investigate, Anna-Therese Lehnich, of the University of Duisburg-Essen in Germany and her colleagues analysed 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.
Lehnich said: “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—‘uncommon,’ ‘common,’ and ‘very common’—for the occurrence of sleep disturbances from patient information leaflets result in different frequencies of sleep disturbances.”