Effectiveness of prolonged-release melatonin in Improving Quality of Sleep in Patients Aged 55 or Over

Objective: to evaluate the efficacy of prolonged-release melatonin used in routine practice to improve sleep quality in Russian patients over 55 years of age.

Patients and methods. The results of the multicenter open-label observational study of Circadin (prolonged-release melatonin) efficiency for treatment of insomnia in 36 patients older than 55 yeare presented. The drug was administered at a dose of 2 mg one-two hours before bedtime for 3 weeks.

Results. Treatment with Circadin resulted in statistically significant (p<0.0001) according to pared t-test (95% CI: 4.8; 7.3) improvement of the sleep quality: the mean value of the modified subjective sleep characteristics scale increased from 11.8±2.6 points at baseline to 17.8±2.3 points after 3 weeks of treatment. The modified Questionnaire Scoring Subjective Characteristics of Sleep was grade from 0 (very bad) to 20 (very good) taking into account: the amount of time required to fall asleep, the sleep duration, the number of night awakenings and the general well-being in the morning. An increase of 6 points on a scale from 0 to 20 was considered as clinically relevant. A greater effect was observed in patients with severely impaired sleep quality as well as with low level of depression and anxiety and absence of cognitive impairment. Upon completion of Circadin treatment there were statistically significant improvement (p<0.0001) of attention (the mean value of the symbol-digit coding test increased from 34.2±9.7 to 37.3±10.6 points) and memory (the median value of the short-term verbal memory test increased from 4 points at baseline to 5 points at the study end, p=0.0069).

The drug had a good safety profile; only one adverse event related to study medication (allergic rush) was registered in the study. The absolute majority (91.7%) of the study patients considered Circadin treatment as either effective or very effective.

Conclusion. Taking into consideration the good safety profile of this drug, confirmed in the present study, as well as the ability of the drug to improve cognitive functions, Circadin may be beneficial in patients from 55 years with insomnia complaint.

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