ZOLPIDEM-LUPIN zolpidem tartrate 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

zolpidem tartrate, Quantity: 10 mg

Available from:

Lupin Australia Pty Limited

INN (International Name):

zolpidem tartrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type A; hypromellose; magnesium stearate; titanium dioxide; macrogol 400

Administration route:

Oral

Units in package:

14 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Zolpidem tartrate is indicated for the short term treatment of insomnia in adults (See Dosage and Administration).

Product summary:

Visual Identification: White coloured, capsule shaped, film coated tablets debossed with "10" on one side and breakline on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-04-24

Patient Information leaflet

ZOLPIDEM-LUPIN TABLETS
(Lupin Australia Pty Ltd)
CONSUMER MEDICINE INFORMATION
WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH UNUSUAL AND POTENTIALLY
DANGEROUS BEHAVIOURS
WHILST APPARENTLY ASLEEP. THESE HAVE INCLUDED SLEEP WALKING, DRIVING
MOTOR VEHICLES AND
OTHER BIZARRE BEHAVIOURS. SOME MEDICINES MAY INTERACT WITH ZOLPIDEM
AND PARTICULAR
CAUTION IS NEEDED WITH OTHER DRUGS THAT MAY ALSO ACT ON THE BRAIN;
BEFORE YOU TAKE
ZOLPIDEM REFER TO THE "TAKING OTHER MEDICINES" SECTION BELOW OR ASK
YOUR DOCTOR OR
PHARMACIST. YOU MUST NOT DRINK ALCOHOL WHEN YOU TAKE ZOLPIDEM. DO NOT
TAKE ZOLPIDEM FOR
MORE THAN 4 WEEKS. IF YOUR SLEEP PROBLEMS CONTINUE, CONSULT YOUR
DOCTOR.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ZOLPIDEM-LUPIN. It
does not contain all the available information. It does
not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of taking ZOLPIDEM -LUPIN against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS ZOLPIDEM-LUPIN IS USED FOR
ZOLPIDEM-LUPIN is used to initiate and maintain sleep in those with
sleeping difficulties, also called insomnia. It is not
recommended for use for more than 4 weeks at a time.
ZOLPIDEM-LUPIN has a different chemical structure to any other
sleeping tablets. ZOLPIDEM-LUPIN works by binding to
special sites in the brain which produce sleep.
Your doctor, however, may prescribe ZOLPIDEM-LUPIN for another
purpose. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE
ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with a doctor’s prescription.
BEFORE YOU TAKE ZOLPIDEM –LUPIN
_WHEN YOU MUST NOT TAKE ZOLPIDEM -LUPIN _
Do not take ZOLPIDEM-LUPIN if you have:
been drinking alcohol or you believe that you may have alcohol in your
bloodstream
sleep apnoea (a condition where you temporarily stop breathing

Summary of Product characteristics

ZOLPIDEM-LUPIN TABLETS
(LUPIN AUSTRALIA PTY. LTD.)
WARNING: ZOLPIDEM MAY BE ASSOCIATED WITH POTENTIALLY DANGEROUS COMPLEX
SLEEP-RELATED
BEHAVIOURS WHICH MAY INCLUDE SLEEP WALKING, SLEEP DRIVING AND OTHER
BIZARRE BEHAVIOURS.
ZOLPIDEM IS NOT TO BE TAKEN WITH ALCOHOL. CAUTION IS NEEDED WITH OTHER
CNS DEPRESSANT
DRUGS. LIMIT USE TO FOUR WEEKS MAXIMUM UNDER CLOSE MEDICAL
SUPERVISION.
DESCRIPTION:
Zolpidem tartrate is a white to off white colourless, crystalline
powder, sparingly soluble in water. Its chemical name is
2-(4-methylphenyl)-N, N, 6-trimethylimidazo [1, 2, a]
pyridine-3-acetamide hemitartrate.
Its molecular formula is (C
19
H
21
N
3
O)
2
, C
4
H
6
O
6.
MW is 764.9
CAS numbers are 99294-93-6 (zolpidem tartrate) and 82626-48-0
(zolpidem)
Each table contains zolpidem tartrate 10 mg with lactose, cellulose -
microcrystalline, hypromellose, sodium starch
glycollate (Type A) and magnesium stearate. The coating on the tablets
consists of hypromellose, titanium dioxide
and macrogol 400.
PHARMACOLOGY:
PHARMACODYNAMICS
Zolpidem belongs to the imidazopyridine group of compounds and is
structurally unrelated to other hypnotic agents.
Zolpidem selectively binds the omega-1 receptor subtype (also known as
the benzodiazepine-1 subtype) which is the
alpha unit of the GABA-A receptor complex. Whereas benzodiazepines
non-selectively bind all three omega receptor
subtypes, zolpidem preferentially binds the omega-1 subtype. The
modulation of the chloride anion channel via this
receptor leads to the specific sedative effects demonstrated by
zolpidem i.e. the preservation of deep sleep (stage 3
and 4 slow wave sleep).
These effects are reversed by the benzodiazepine antagonist
flumazenil.
_In animals: _ The selective binding of zolpidem to omega-1 receptors
may explain the virtual absence at hypnotic
doses of myorelaxant and anti-convulsant effects in animals which are
normally exhibited by benzodiazepines which
are not selective for omega-1 sites.
_Zolpidem-Lupin _
_PI _
_V5 29/06/10 _
_In humans: _The preservation of deep slee