ZOLPIDEM ARW zolpidem tartrate 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

zolpidem tartrate

Available from:

Arrow Pharma Pty Ltd

INN (International Name):

zolpidem tartrate

Authorization status:

Registered

Patient Information leaflet

STILDEM- Consumer Medicine Information
Page 1 of 4
STILDEM
_ _
_Zolpidem tartrate_
_ _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
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
STILDEM
It does not contain all of the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking STILDEM
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
TALK TO YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT STILDEM IS
USED FOR
STILDEM is used to initiate and
maintain sleep in those with
sleeping difficulties, also called
insomnia.
STILDEM works by binding to
special sites in the brain which
produce sleep. It has a different
chemical structure to other
sleeping tablets.
In general, sleeping tablets such
as STILDEM are not
recommended for use for more
than 4 weeks at a time.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
STILDEM WAS PRESCRIBED FOR
YOU.
STILDEM is only available with
a prescription.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE_
_ _
_STILDEM _
_ _
DO NOT TAKE STILDEM IF YOU
ARE ALLERGIC TO ZOLPIDEM OR
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include
shortness of breath, wheezing
or difficulty breathing; swelling
of the face, lips

Summary of Product characteristics

AUSTRALIAN PI – STILDEM (ZOLPIDEM)
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.
1
NAME OF THE MEDICINE
Zolpidem
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zolpidem tartrate is a white to off-white colourless, hygroscopic,
crystalline powder, slightly soluble
in water.
STILDEM tablets come in one strength and contain 10 mg of zolpidem
tartrate. The tablets contain
lactose monohydrate. For full list of excipients, see section 6.1 LIST
OF EXCIPIENTS
3
PHARMACEUTICAL FORM
White film coated, capsule-shaped tablet, with a break line on both
faces and engraved with ‘Z’ and
‘10’ on either side of the break line on both faces.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Short-term
treatment
of
insomnia
in
adults
(see
section
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION).
4.2
D
OSE AND METHOD OF ADMINISTRATION
Zolpidem acts rapidly and should therefore be taken immediately before
retiring. As with all hypnotics,
long-term use is not recommended. Treatment should be as short as
possible and should not exceed
four weeks.
DISCONTINUATION OF TREATMENT. See section 4.8 ADVERSE EFFECTS.
WITHDRAWAL EFFECTS. See section 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE.
RECOMMENDED DOSAGE. ADULTS. 10 mg to be taken at night.
ELDERLY OR DEBILITATED PATIENTS. Since elderly or debilitated patients
may be especially sensitive to the
effects of zolpidem, 5 mg to be taken at night is recommended. This
dose should not be exceeded.
HEPATIC IMPAIRMENT. As clearance and metabolism of zolpidem is reduced
in hepatic impairment,
dosage of 5 mg to be taken at night is recommended, with particular
caution being exercised in elderly
patients. In adults less than 65 years the dosage may be increased if
the clinical response is inadequate
and the drug is well tolerated.