Zolpidem 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zolpidem tartrate

Available from:

IVAX Pharmaceuticals UK Ltd

ATC code:

N05CF02

INN (International Name):

Zolpidem tartrate

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
ZOLPIDEM 5MG OR 10MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
•
Your doctor may have given you this medicine before from another
company. It may
have looked slightly different. However, either brand will have the
same effect.
WHAT IS IN THIS LEAFLET:
1.
What zolpidem is and what it is used for
2.
What you need to know before you take zolpidem
3.
How to take zolpidem
4.
Possible side effects
5.
How to store zolpidem
6.
Contents of the pack and other information
1. WHAT ZOLPIDEM IS AND WHAT IT IS USED FOR
The name of your medicine is Zolpidem 5mg or 10mg Tablets (called
zolpidem throughout
this leaflet). Zolpidem contains a medicine called zolpidem tartrate.
This belongs to a group
of medicines called hypnotics. It works by acting on your brain to
help you sleep.
Zolpidem is used for temporary sleep problems in adults that are
causing you severe distress
or that are affecting your everyday life. This includes sleep problems
in adults such as:
•
Difficulty falling asleep
•
Waking in the middle of the night
•
Waking too early
Your doctor will identify your sleep problem wherever possible and the
underlying factors
before prescribing this medicine for you. The failure of your sleep
problems to stop after a 7-
14 day course of treatment may indicate you have an underlying
disorder, your doctor will
assess you at regular intervals.
Zolpidem is used for short-term treatment of insomnia in adults. Do
not use long-term.
Treatment should be as short as possible, because th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zolpidem Tartrate 5 mg Tablets
2
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each tablet contains 5 mg zolpidem tartrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Round, white, film-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zolpidem is indicated for the short-term treatment of insomnia in
adults in situations
where the insomnia is debilitating or is causing severe distress for
the patient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment should be taken in a single intake and not be
re-administered during the
same night.
The recommended daily dose for adults is 10 mg to be taken immediately
at bedtime.
The lowest effective daily dose of zolpidem should be used and must
not exceed 10
mg.
Treatment should be as short as possible. It should not exceed four
weeks including
the period of tapering off. In certain cases extension beyond the
maximum treatment
period may be necessary; if so, extension beyond the maximum treatment
period
should not take place without re-evaluation of the patient’s status,
since the risk of
abuse and dependence increases with the duration of treatment (see
section 4.4).
Special populations
_Paediatric population _
Zolpidem is not recommended for use in children and adolescents below
18 years of
age, due to a lack of data to support use in this age group. The
available evidence
from placebo-controlled clinical trials is presented in section 5.1.
_Elderly _
Elderly or debilitated patients may be especially sensitive to the
effects of zolpidem
therefore a 5 mg dose is recommended. These recommended doses should
not be
exceeded.
_Hepatic impairment _
As clearance and metabolism of zolpidem is reduced in hepatic
impairment, dosage
should begin at 5 mg in these patients with particular caution being
exercised in
elderly patients. In adults (under 65 years) dosage may be increased
to 10 mg only
where the clinical response is inadequate and t