Pharmacological Research, Vol . 25, Supplement 1, 1992
83
NIAPRAZINE VS CHLORDESMETHYLDIAZEPAM IN SLEEP DISTURBANCES IN PEDIATRIC OUTPATIENTS . G .Montanari, P .Schiaulini, A .Covre, A .Steffan *, M .Furlanut . Gruppo di studio per i disturbi del sonno, Cattedra di Farmacologia e Servizio di Farmacologia Clinica e Tossicologia, Istituto di Scienze Mediche, Universita' di Udine, * Servizio di Medicina dell' eta' evolutiva, USL 12 "Del Livenza", Sacile (Pordenone) . pediatric
Key words : niaprazine, chlordesmethyldiazepam, sleep disturbances . Sleep
disturbances
represent
a
common problem
in pediatric
practice (1-2), particularly in the first three years of life . Antihistamines,
probably are
the most prescribed drugs
for
sleep disturbances in children, whereas benzodiazepines (BDZ) are
the drugs
of
choice
studies comparing antihistamines published .
for
activity
in
adults . and
pediatric
Therefore,
our knowledge,
At
tolerance
of
BDZ
sleep disturbances
no
versus
have
been
60 children aged between 1 month and
three years
(mean 13 .33 ± 7 .77 months)
disturbances
were
affected with sleep
selected to partecipate
a
in
comparative
study . Informed consent was obtained from the parents . After a complete clinical evaluation and a 3-month observation period, either Niaprazine,
a drug with antihistaminic activity (2), or
Chlordesmethyldiazepam administered
at
(CDD),
random
for
a 10
long-acting BDZ consecutive
days .
hypnotic effect was reported with either drug .
(3),
were
A
rapid
At day 10 of
treatment, about 3/4 of children who completed the period of therapy
(Table
1),
showed
a
clear
improvement
in
sleep
disturbances, particularly night awakenings . At drug withdrawal and during the following 10 days of observation, over a third of the patients maintained the positive effect obtained (about 3/4 of the patients in the case of night awakenings) . No 1043-6618/92/2510083-02/$03 .00/0
O 1992 The Italian Pharmacological Society
84
Pharmacological Research, Vol . 25, Supplement 1, 1992
significant difference between the two drugs was recorded . CDD and Niaprazine were well tolerated without any serious side effect .
However
paradoxical
4
effect
children
on
CDD
treatment
requiring drug withdrawal .
showed
a
Our findings
indicate that both drugs are effective and safe in children sleep disturbances ; however, Niaprazine is perhaps preferable as a first-choice drug, especially when administered only for a few days . Table 1 . Analysis of the drug effect on the single sleep disturbances at the tenth day of therapy . Sleep disturbance
Drug administered CDD Improved* Not improved
Niaprazine Improved* Not improved
12 (80%)
3 (20%)
15 (83 .33%)
3 (16 .67%)
Early awakenings
11 (91 .67%)
1 (8 .33%)
19 (73 .08%)
7 (26 .92%)
Night awakenings
23 (88 .46%)
3 (11 .54%)
Difficulty falling asleep
26 (100%)
0
* In the case of night awakenings = reduction of at least 50% in the number of awakenings . Chi-square = Not significant REFERENCES 1) Bax MCD . Sleep disturbances in the young child . Br Med J, 1980 ; 280 : 1177-1179 . 2) Simonds JF, Parraga H . Prevalence of sleep disorders and sleep behaviors in children and adolescents . J Amer Acad Child Psichiatry, 1982 ; 21 (4) : 383-388 . 3) Besana R, Fiocchi A, De Bartolomeis L, Magno F, Donati C . Comparison of niaprazine and placebo in pediatric behaviour and sleep disorders : double blind clinical trial . Curr Ther Res, 1984 ; 36 : 58-66 . 4) Furlanut M, Da Giau F, Casara G, Montanari G, Zacchello F . Chlordesmethyldiazepam (CDD) disposition in children . First European Congress of biopharmaceutics and pharmacokinetics, Clermond - Ferrand 1,2,3 April 1981 . Proceedings, Vol . 3 . Clinical Pharmacokinetics, Paris, 1981 ; 297-303 .
83
NIAPRAZINE VS CHLORDESMETHYLDIAZEPAM IN SLEEP DISTURBANCES IN PEDIATRIC OUTPATIENTS . G .Montanari, P .Schiaulini, A .Covre, A .Steffan *, M .Furlanut . Gruppo di studio per i disturbi del sonno, Cattedra di Farmacologia e Servizio di Farmacologia Clinica e Tossicologia, Istituto di Scienze Mediche, Universita' di Udine, * Servizio di Medicina dell' eta' evolutiva, USL 12 "Del Livenza", Sacile (Pordenone) . pediatric
Key words : niaprazine, chlordesmethyldiazepam, sleep disturbances . Sleep
disturbances
represent
a
common problem
in pediatric
practice (1-2), particularly in the first three years of life . Antihistamines,
probably are
the most prescribed drugs
for
sleep disturbances in children, whereas benzodiazepines (BDZ) are
the drugs
of
choice
studies comparing antihistamines published .
for
activity
in
adults . and
pediatric
Therefore,
our knowledge,
At
tolerance
of
BDZ
sleep disturbances
no
versus
have
been
60 children aged between 1 month and
three years
(mean 13 .33 ± 7 .77 months)
disturbances
were
affected with sleep
selected to partecipate
a
in
comparative
study . Informed consent was obtained from the parents . After a complete clinical evaluation and a 3-month observation period, either Niaprazine,
a drug with antihistaminic activity (2), or
Chlordesmethyldiazepam administered
at
(CDD),
random
for
a 10
long-acting BDZ consecutive
days .
hypnotic effect was reported with either drug .
(3),
were
A
rapid
At day 10 of
treatment, about 3/4 of children who completed the period of therapy
(Table
1),
showed
a
clear
improvement
in
sleep
disturbances, particularly night awakenings . At drug withdrawal and during the following 10 days of observation, over a third of the patients maintained the positive effect obtained (about 3/4 of the patients in the case of night awakenings) . No 1043-6618/92/2510083-02/$03 .00/0
O 1992 The Italian Pharmacological Society
84
Pharmacological Research, Vol . 25, Supplement 1, 1992
significant difference between the two drugs was recorded . CDD and Niaprazine were well tolerated without any serious side effect .
However
paradoxical
4
effect
children
on
CDD
treatment
requiring drug withdrawal .
showed
a
Our findings
indicate that both drugs are effective and safe in children sleep disturbances ; however, Niaprazine is perhaps preferable as a first-choice drug, especially when administered only for a few days . Table 1 . Analysis of the drug effect on the single sleep disturbances at the tenth day of therapy . Sleep disturbance
Drug administered CDD Improved* Not improved
Niaprazine Improved* Not improved
12 (80%)
3 (20%)
15 (83 .33%)
3 (16 .67%)
Early awakenings
11 (91 .67%)
1 (8 .33%)
19 (73 .08%)
7 (26 .92%)
Night awakenings
23 (88 .46%)
3 (11 .54%)
Difficulty falling asleep
26 (100%)
0
* In the case of night awakenings = reduction of at least 50% in the number of awakenings . Chi-square = Not significant REFERENCES 1) Bax MCD . Sleep disturbances in the young child . Br Med J, 1980 ; 280 : 1177-1179 . 2) Simonds JF, Parraga H . Prevalence of sleep disorders and sleep behaviors in children and adolescents . J Amer Acad Child Psichiatry, 1982 ; 21 (4) : 383-388 . 3) Besana R, Fiocchi A, De Bartolomeis L, Magno F, Donati C . Comparison of niaprazine and placebo in pediatric behaviour and sleep disorders : double blind clinical trial . Curr Ther Res, 1984 ; 36 : 58-66 . 4) Furlanut M, Da Giau F, Casara G, Montanari G, Zacchello F . Chlordesmethyldiazepam (CDD) disposition in children . First European Congress of biopharmaceutics and pharmacokinetics, Clermond - Ferrand 1,2,3 April 1981 . Proceedings, Vol . 3 . Clinical Pharmacokinetics, Paris, 1981 ; 297-303 .
