Questions about the applicability of a drug’s Summary of Product Characteristics (SPC) to the general population have been raised by a study in the British Journal of Clinical Pharmacology.
German researchers asked 4,221 people aged 45-75 years about difficulties falling asleep or maintaining sleep, and early morning arousal. They used the SPC to determine the likelihood that each drug taken by the patients could cause sleep disturbances.
Each additional drug taken by the patients that the SPC suggested could disturb sleep did not significantly alter sleep disturbances reported by men or women. There was no significant association between additional sleep disturbing drugs and any of the three types of disturbance. The risk of nocturnal sleep disturbances did not rise as the cumulative probability for drug-related sleep disturbances increased.
The authors concluded that information in the SPC “may lack generalisability to the general population or may be of limited data quality”. The extent to which information on adverse drug reactions in the SPC applies to the general population needs further research, especially regarding more severe adverse reactions.
“Standardised recording of adverse drug reactions in clinical trials is required, and physicians and pharmacists should be more careful in reporting adverse drug reactions,” they comment.