Stilnoct 10 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zolpidem tartrate

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N05CF; N05CF02

INN (International Name):

Zolpidem tartrate

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine related drugs; zolpidem

Authorization status:

Marketed

Authorization date:

1993-02-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STILNOCT® 5MG FILM-COATED TABLETS AND
STILNOCT® 10MG FILM-COATED TABLETS
_zolpidem tartrate _
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP.
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 side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this
leaflet. See Section 4.
WHAT IS IN THIS LEAFLET:
1. What Stilnoct is and what it is used for
2. What you need to know before you take Stilnoct
3. How to take Stilnoct
4. Possible side effects
5. How to store Stilnoct
6. Contents of the pack and other information
1. WHAT STILNOCT IS AND WHAT IT IS USED FOR
The name of your medicine is Stilnoct. The tablets come in two
strengths:
Stilnoct 5mg Tablets and Stilnoct 10mg Tablets.
Zolpidem tartrate belongs to a group of medicines called hypnotics. It
works by acting on your brain to help you sleep.
Stilnoct is used for short-term treatment of insomnia in patients over
18 years of age that are causing severe distress or
that are affecting every day life.
This includes sleep problems such as:
• Difficulty falling asleep
• Waking in the middle of the night
• Waking too early
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STILNOCT
DO NOT TAKE STILNOCT :
• As long-term treatment. Treatment should be as short as possible,
because the risk of dependence
increases with the duration of treatment.
• If you have ever experienced sleep walking or other behaviours
which are unusual while sleeping, (such as driving, eating,
making a phone call or having sex etc.) while not being fully awake
after taking Stilnoct or other medicines containing
zolpidem.
• If you are

Summary of Product characteristics

Health Products Regulatory Authority
19 January 2022
CRN009ZQD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stilnoct 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: Zolpidem tartrate 10mg
Excipients: also contains Lactose monohydrate 90.4mg per tablet.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oblong, white, scored tablet engraved ‘SN10’.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
For oral use.
Zolpidem tartrate acts rapidly and therefore should be taken
immediately before retiring, or in bed.
The treatment should be taken in a single intake and not be
re-administered during the same night. The recommended daily
does for adults is 10mg to be taken immediately at bedtime. The lowest
effective daily dose of zolpidem should be used and
must not exceed 10mg.
The duration of treatment should usually vary from a few days to two
weeks with a maximum of four weeks including
tapering off where clinically appropriate.
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