Alodorm

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Nitrazepam

Patient Information leaflet

ALODORM

_contains the active ingredient nitrazepam_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Alodorm.
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 Alodorm against
the benefits expected 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 ALODORM IS USED
FOR
Alodorm is used to treat insomnia
(sleeping problems).
Alodorm contains the active
ingredient nitrazepam, which belongs
to a group of medicines called
benzodiazepines. These medicines
are thought to work by their action
on brain chemicals.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ALODORM HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Alodorm for another reason.
In general, benzodiazepines such as
Alodorm should be taken for short
periods only (for example 2 to 4
weeks). Continuous long-term use is
not recommended unless advised by
your doctor. The use of
benzodiazepines may lead to
dependence on the medicine.
Alodorm is available only with a
doctor's prescription.
BEFORE YOU TAKE
ALODORM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ALODORM IF YOU ARE
ALLERGIC TO:
•
nitrazepam
•
any other benzodiazepine
medicine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing;
wheezing or shortness of breath.
DO NOT TAKE ALODORM IF YOU HAVE:
•
severe and chronic lung disease
(e.g. chronic obstructive airway
disease) and difficulty breathing
•
severe liver disease.
DO NOT TAKE ALODORM AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damag

Summary of Product characteristics

ALODORM 
_Nitrazepam _
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
Active ingredient: 
Nitrazepam 
Chemical name:  
7-nitro-5-phenyl-1,3-dihydro-2_H_-1,4-benzodiazepin-2-one 
Structural formula: 

Molecular formula: 
C
15
H
11
N
3
O
3 

Molecular weight: 
281.3 

CAS Registry No.: 
146-22-5  
DESCRIPTION

Nitrazepam is a yellow, crystalline powder which is odourless
and tasteless.  It is almost insoluble in water, soluble in 
120 parts of alcohol (95%), in 45 parts of
chloroform, and in 900 parts of solvent ether.  Nitrazepam has
a melting 
point of 226
° - 229°C. 
Each tablet contains 5 mg of
nitrazepam as the active ingredient. 
The tablets also contain the following inactive 
ingredients: lactose, starch –  maize, starch –  pregelatinised maize, talc –  purified, silica –  colloidal anhydrous, 
magnesium stearate.  
PHARMACOLOGY 
Nitrazepam is a member of the group of benzodiazepine agonists
and exhibits sedative, anxiolytic, anticonvulsant 
and muscle relaxant effects. 
This is presumed to be the result of facilitating the action in the brain of
gamma-
aminobutyric acid (GABA), an endogenous inhibitor
neurotransmitter. 
Taken in the evening in recommended doses, nitrazepam induces
sleep lasting 6 to 8 hours. 
PHARMACOKINETICS 
_ABSORPTION._  Nitrazepam is well
and fairly rapidly absorbed from the gastrointestinal tract. 
The time to reach peak 
plasma concentrations following oral administration is about
2 hours (0.5 to 5 hours). 
Peak plasma levels following a 10 mg single oral
dose are about
68 to 108 ng/mL and following a 5 mg single oral 
ALODORM – Product Information 
2 

dose about 25 to 50 ng/mL.  Twelve hours after oral
administration of 5 mg of
nitrazepam, blood levels are about 12 
to 38 ng/mL. 
_BIOAVAILABILITY._  In one study com