SOBRIUM TABLETS 10 mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ZOLPIDEM TARTRATE

Available from:

RANBAXY (MALAYSIA) SDN. BHD.

INN (International Name):

ZOLPIDEM TARTRATE

Units in package:

3 x 10 Tablets; 10 x 10 Tablets; 100 Tablet Tablets; 30 Tablet Tablets

Manufactured by:

RANBAXY (MALAYSIA) SDN. BHD.

Summary of Product characteristics

_For the use of a Registered Medical Practitioner only_
PRESCRIBING
INF
O
R
M
A
T
ION
SOBRIUM T
ABLE
T
S
(ZOLPIDEM TARTRATE TABLETS 10 MG
)
COMPOSITION
Each film coated tablets contains:
Zolpidem Tartrate BP 10 mg
EXCIPIENTS: Lactose monohydrate, microcrystalline cellulose, sodium
starch glycollate,
magnesium stearate, opadry OY 58910 white, purified water.
PRODUCT DESCRIPTION
White to off-white film coated, circular, biconvex tablets
DESCRIPTION
Zolpidem Tartrate is the tartrate salt of an imidazopyridine with
non-benzodiazepine
benzodiazepine-receptor agonist and sedative-hypnotic activities. It
has a molecular
formula of C
23
H
27
N
3
O
7
and a molecular weight of 457.47638 g/mol. It has the following
structural formula.
STRUCTURAL
F
ORM
ULA
ZOLPIDEM T
AR
T
R
AT
E
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
•
PHARMACODYNAMICS
Pharmacologically,
zolpidem
binds
selectively
to
the
omega-1
subclass
(or
BZ1)
of
benzodiazepine receptors in the brain without binding to peripheral
benzodiazepine
receptors. This has been corroborated by the observation that zolpidem
has little or no
muscle relaxant properties.
Zolpidem has been shown to reduce sleep latency (time to fall asleep),
decrease the
number
of
awakenings, and
to
increase total
sleep
time.
While
REM
sleep
is
not
significantly decreased, the onset of REM is delayed. The REM/non-REM
ratio is not
significantly altered. Slow wave (stages 3 and 4) sleep time is
increased. This more
closely resembles natural sleep than does hypnosis induced by the
benzodiazepines; this
may result in fewer adverse reactions related to disturbance of normal
sleep patterns.
•
PHARMACOKINETICS
_Absorption_
Zolpidem is rapidly absorbed from the gastrointestinal tract after
oral doses, peak
plasma concentrations occurring within 3 hours. Oral bioavailability
is 70%.
_Effect of food_: decreased systemic exposure (decreased C
max
and AUC; increased T
max
).
_Distribution_
Zolpidem is about 92% bound to plasma proteins. The distribution
volume in adults is
0.54L/kg Zolpidem is distribu