STILNOCT Coated tablet Ref.[7405] Active ingredients: Zolpidem

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK

Product name and form

Stilnoct 5 mg film-coated Tablets.

Pharmaceutical Form

Coated tablets for oral administration.

Qualitative and quantitative composition

Round white film-coated tablets containing 5 mg zolpidem tartrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Zolpidem

Zolpidem is an imidazopyridine which preferentially binds the omega-1 receptor subtype (also known as the benzodiazepine-1 subtype) which corresponds to GABA-A receptors containing the alpha-1 sub-unit, whereas benzodiazepines non-selectively bind both omega-1 and omega-2 subtypes. The modulation of the chloride anion channel via this receptor leads to the specific sedative effects demonstrated by zolpidem. These effects are reversed by the benzodiazepine antagonist flumazenil.

List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose
Hypromellose
Sodium starch glycollate
Magnesium stearate

Film coating:

Hypromellose
Titanium dioxide (E171)
Polyethylene glycol 400

Pack sizes and marketing

Cartons of 4, 14, 28 or 56 tablets in PVC/foil blister strips of 7 or 14 tablets.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK

Trading as:

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK

Marketing authorization dates and numbers

PL 04425/0618

03 December 2009

Drugs

Drug Countries
STILNOCT Finland, Ireland, Netherlands, United Kingdom

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