Effects of Melatonin in Elderly Patients with Sleep Disturbance: a Pilot Study

This openlabe l , s h o r t t e r m p i l o t s t u d y was des igned to a s s e s s t h e ef f icacy and t o l e r a b i l i t y o f m e l a t o n i n in t h e t r e a t m e n t o f s l e e p dist u r b a n c e s in e l de r l y p a t i e n t s . The 41 p a t i e n t s (28 w o m e n and 13 men; m e a n age [±SD], 74 ± 12 y e a r s ) we re s e p a r a t e d in to t h r e e groups : ( 1 ) p a t i e n t s w i th s l e e p d i s t u r b a n c e s a lone ( n = 22); ( 2 ) p a t i e n t s w i th s l eep d i s t u r b a n c e s and s igns o f d e p r e s s i o n ( n = 9); a n d ( 3 ) p a t i e n t s w i th s l e e p d i s t u r b a n c e s and d e m e n t i a o f t h e d e g e n e r a t ive o r v a s c u l a r t y p e ( n = 10). Al l p a t i e n t s r e c e i v e d 3-mg ge l a t i n capsu l e s o f m e l a t o n i n o ra l ly 30 m i n u t e s b e f o r e e x p e c t e d s l eep t ime fo r 21 days . Overa l l s l eep qua l i t y and d a y t i m e a l e r t n e s s we re ass e s s e d by m e a n s o f s t r u c t u r e d c l in ica l i n t e rv i e w s a n d s l eep logs c o m p l e t e d by t h e p a t i e n t s ( o r t h e i r c a r eg ive r s in t he case o f dement i a p a t i e n t s ) . S t a r t i n g f rom day 2 o r 3 o f t r e a t m e n t , m e l a t o u l n sign i f i c a n t l y i m p r o v e d s l e e p q u a l i t y a n d d e c r e a s e d t h e n u m b e r o f a w a k e n i n g s in p a t i e n t s w i th s l e e p d i s t u r b a n c e s wi th o r w i t h o u t ass o c i a t e d dep re s s ion . P a t i e n t s w i th d e m e n t i a d id n o t show signif i c an t i m p r o v e m e n t o f s l eep qua l i ty . E s t i m a t e s o f n e x t d a y func t ion ( ie , a l e r t n e s s in t he morn ing and dur ing t h e d a y ) i m p r o v e d s ignif i c an t l y on ly in p a t i e n t s exh ib i t i ng s l eep d i s t u r b a n c e s a lone . Cl in ica l a s s e s s m e n t i n d i c a t e d t h a t s y m p t o m s i m p r o v e d in 16 (73%) o f t he p a t i e n t s w i th s l eep d i s t u r b a n c e s a lone and 4 (44%) o f t h o s e wi th s l e e p d i s t u r b a n c e s a s s o c i a t e d w i th d e p r e s s i o n , a n d t h a t a g i t a t e d b e h a v i o r a t n igh t ( s u n d o w n i n g ) d e c r e a s e d s ign i f i can t ly in 7 (70%) o f t h e p a t i e n t s w i th demen t i a . This was r e f l e c t e d by t h e coe f f i c i en t o f v a r i a t i o n o f b e d t i m e , which a v e r a g e d 58% in p a t i e n t s w i th dement i a c o m p a r e d wi th 27% and 33% in n o n d e p r e s s e d and d e p r e s s e d p a t i e n t s , r e spec t ive ly , on days 0 to 2 o f t r e a t m e n t , a n d which dec r e a s e d s ign i f i can t ly on ly in d e m e n t i a p a t i e n t s when r e a s s e s s e d on days 19 to 21. F o u r (31%) o f t h e 13 p a t i e n t s w i th p r i m a r y i n s o m n i a who were r ece iv ing b e n z o d i a z e p i n e s c o n c o m i t a n t l y r e d u c e d t h e i r b e n z o d i a z e p i n e use ( b y 50% to 75% o f in i t i a l d o s e s ) and 4 (31%) d i s c o n t i n u e d use o f t h e s e agen t s ; o f t h e 7 p a t i e n t s wi th d e p r e s s i o n a n d 7 wi th d e m e n t i a who w e r e rece iv ing b e n z o d i a z e p i n e s concomit an t ly , 2 (29%) in each g roup r e d u c e d b e n z o d i a z e p i n e use by up t o Address correspondence to: D. P. Cardinali, MD, Phi), Departamento de Fisiologia, Facultad de Medicina, UBA CC 243, 1425 Buenos Aires, Argentina. Received for publication on September 10, 1997. Printed in the U.S.A. Reproduction in whole or part is not permitted. 990 0011-393x]97/$3.50