ABSENCE OF EFFECTS OF PROLONGED SIMVASTATIN THERAPY ON NOCTURNAL SLEEP IN A LARGE RANDOMIZED PLACEBO-CONTROLLED STUDY

1 It has been suggested that lipophilic HMG CoA reductase inhibitors, like lovastatin and simvastatin, may cause sleep disturbance. 2 Six hu ndred and twenty-one patients at increased risk of coronary heart dise ase were randomized in a single centre to receive 40 mg daily simvasta tin, 20 mg daily simvastatin or matching placebo, To assess the effect s of prolonged use of simvastatin on nocturnal sleep quality and durat ion, a sleep questionnaire was administered to 567 patients (95% of 59 5 survivors) at an average of 88 weeks (range: 44-129 weeks) after ran domization. 3 The main outcome measures were sleep-related problems an d use of sleep-enhancing medications reported during routine study fol low-up visits, and responses to the sleep questionnaire about changes in sleep duration and about various sleep events during the preceding month. 4 No differences were observed between the treatment groups in the frequency of sleep-related problems reported, in the proportion of follow-up visits at which such problems were reported, or in the use of sleep-enhancing medications, The numbers who stopped study treatmen t were similar in the different treatment groups, and no patient stopp ed principally because of insomnia. In response to the sleep questionn aire, there were no significant differences between the treatment grou ps in reports of various sleep events during the preceding month, exce pt that slightly fewer patients allocated simvastatin reported waking often. No differences in sleep duration were observed. 5 This placebo- controlled trial does not indicate any adverse effects of prolonged tr eatment with simvastatin on systematically sought measures of sleep di sturbance.