Hypnodorm

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Flunitrazepam

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

HYPNODORM
1
HYPNODORM
_contains the active ingredient flunitrazepam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Hypnodorm.
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 Hypnodorm
against the benefits they expect it
will have 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 HYPNODORM IS
USED FOR
Hypnodorm is used to treat severe
cases of insomnia (trouble sleeping). 
Hypnodorm belongs to a group of
medicines called benzodiazepines.
These medicines are thought to work
by their action on brain chemicals. 
In general, benzodiazepines such as
Hypnodorm need only be taken for a
few nights and then discontinued by
gradually decreasing the dosage.
Continuous long term use of
Hypnodorm is not recommended.
The use of benzodiazepines may lead
to dependence on the medicine. 
Your doctor may have prescribed
Hypnodorm for another reason. Ask
your doctor if you have any
questions about why Hypnodorm has
been prescribed for you. 
Hypnodorm is available only with a
doctor's prescription. 
BEFORE YOU TAKE
HYPNODORM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE HYPNODORM IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING
FLUNITRAZEPAM, ANY OTHER
BENZODIAZEPINE OR 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 HYPNODORM IF YOU
HAVE: 
*
severe and chronic lung disease
*
myasthenia gravis, condition
where there is severe muscle
weakness
*
sleep apno

Summary of Product characteristics

HYPNODORM 
_Flunitrazepam _

PRODUCT INFORMATION 

NAME OF THE MEDICINE 

Flunitrazepam 

Chemical name: 5-(2-fluorophenyl)-1,3-dihydro-1-methyl-7-nitro-2H-1,4-benzodiazepin-2-one. 

Structural formula: 

Molecular formula: C
16
H
12
FN
3
O
3

Molecular weight: 313.3 

CAS Registry no.: 1622-62-4 

DESCRIPTION

Flunitrazepam  is  a  pale  yellow  crystalline  solid,  sparingly  soluble  in  water,  slightly  soluble  in 
alcohol. 

Each  Hypnodorm  tablet  contains  1  mg  flunitrazepam.    The  tablets  also  contain  the  following 
excipients: lactose, maize starch, pregelatinised maize
starch, magnesium stearate, indigo carmine 
CI73015 and Opadry Green OY-LS-21051. 

PHARMACOLOGY

Flunitrazepam  is  a  member  of  the  benzodiazepine  group  of  drugs  and  is  closely  related  to 
nitrazepam, flurazepam  and  clonazepam.   It  has  marked  sedative  and  hypnotic  properties  with  a 
rapid  onset  of  action.    In  experimental  animals,  flunitrazepam  has  also  been  shown  to  possess 
anticonvulsant, anxiolytic and muscle-relaxant properties. 

Given orally, flunitrazepam induces sleep and
maintains and deepens it.  The intensity of the effect 
depends both on the dose taken and on the
aetiology of the sleep disturbance. 

PHARMACOKINETICS 

_Absorption:  _Following  oral  administration,  flunitrazepam  is  almost  completely  absorbed.    Peak 
blood levels of flunitrazepam occur usually 45 minutes after ingestion.  10% to 15% is metabolised 
by a liver first-pass effect, resulting in
bioavailability of 64-77%. 
HYPNODORM 
– Product Information 
2 

Chronic  oral  administration  of  flunitrazepam  leads  to  slight  accumulation  of�