Consumer medicine information

1. Why am I taking DORMIZOL?

DORMIZOL contains the active ingredient zolpidem tartrate. DORMIZOL is used to initiate and maintain sleep in those with sleeping difficulties, also called insomnia in patients over 18 years of age. For more information, see Section 1. Why am I taking DORMIZOL? in the full CMI.

2. What should I know before I take DORMIZOL?

Do not use if you have ever had an allergic reaction to DORMIZOL or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, have been drinking alcohol, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take DORMIZOL? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DORMIZOL and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take DORMIZOL?

• In adults: usual dose is one 10 mg tablet taken just before bedtime.

• In people over 65 years of age: the dose is one 5 mg tablet taken just before bedtime.

5. What should I know while taking DORMIZOL?

6. Are there any side effects?

Common side effects are: drowsiness, dizziness, headache, fatigue, worsened insomnia, hallucinations, delirium, nightmares, agitation, depression, abdominal pain, diarrhoea, nausea and vomiting, back pain, infections of the nose, throat and chest and loss of memory.
If any of the following happen, stop taking this medicine and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital: swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, hives, fainting. Sleep walking, driving motor vehicles and other unusual, and on some occasions dangerous, behaviours whilst apparently asleep may also occur. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

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.

1 Name of Medicine

Zolpidem tartrate.

2 Qualitative and Quantitative Composition

Each tablet contains zolpidem tartrate 10 mg.
Excipient with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Dormizol 10 mg tablets are oblong, scored, white, film-coated tablets marked "SN10".

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. In reports of overdose with Dormizol alone or with other CNS depressant agents (including alcohol), impairment of consciousness has ranged from somnolescence to coma and more severe symptomology, including fatal outcomes have been reported. Fatalities have occurred when overdoses of multi-CNS depressants were taken.
Recommended treatment. General symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. Sedative drugs should be withheld, even if excitation occurs.
Zolpidem has been shown in trials to be non-dialysable.
Use of flumazenil may be considered when serious symptoms are observed. However, flumazenil administration may contribute to the appearance of neurological symptoms, such as convulsions, since zolpidem does not exhibit the anticonvulsant effects of benzodiazepines.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Zolpidem was not genotoxic in assays for gene mutations (Salmonella typhimurium histidine reversion assay, L5178Y mouse lymphoma assay), for chromosomal aberrations (human lymphocytes, mouse micronucleus assay) and for DNA repair assays (in human fibroblasts and rat hepatocytes). The mutagenic activity of zolpidem and/or its metabolites was equivocal in a Chinese hamster V79/HRPT gene mutation assay in the presence of metabolic activation.
Carcinogenicity. Two year dietary carcinogenicity studies on zolpidem were conducted in rats and mice. No evidence of carcinogenic potential was observed in mice at plasma concentrations (AUC) of zolpidem and its major human metabolite of about 2 and 7-12 times, respectively, the anticipated clinical exposure at the maximum recommended clinical dose. An increased incidence of renal liposarcomas was observed in male rats (6% cf. 0 in controls) at plasma concentrations (AUC) of zolpidem and its major metabolite of at least 22 and 9 times, respectively, the anticipated human exposure.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Zolpidem tartrate is a white to off white colourless, crystalline powder, sparingly soluble in water.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSZOLTAR.gif Its chemical name is 2-(4-methylphenyl)-N,N,6-trimethylimidazo [1,2,a] pyridine-3-acetamide hemitartrate.
Its molecular formula is (C₁₉H₂₁N₃O)₂, C₄H₆O₆. MW is 764.9.
CAS number. 99294-93-6 (zolpidem tartrate) and 82626-48-0 (zolpidem).

7 Medicine Schedule (Poisons Standard)

Prescription Medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DORMIZST.gif