TRIAZOLAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRIAZOLAM

Available from:

AA PHARMA INC

ATC code:

N05CD05

INN (International Name):

TRIAZOLAM

Dosage:

0.125MG

Pharmaceutical form:

TABLET

Composition:

TRIAZOLAM 0.125MG

Administration route:

ORAL

Units in package:

70

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0112970001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-11-07

Summary of Product characteristics

1
PRODUCT MONOGRAPH
TRIAZOLAM
Triazolam Tablets USP
0.125 mg and 0.25 mg
Hypnotic
AA PHARMA INC.
DATE OF PREPARATION:
1165 Creditstone Road Unit #1
July 9, 2012
Vaughan, Ontario
L4K 4N7
Control Number: 156855
2
_ _
PRODUCT MONOGRAPH
NAME OF DRUG
TRIAZOLAM
Triazolam Tablets USP
0.125 mg and 0.25 mg
THERAPEUTIC CLASSIFICATION
Hypnotic
ACTIONS
TRIAZOLAM is a benzodiazepine hypnotic with a very short elimination
half-life (about 3
hours).
In sleep laboratory studies of one to 21 days duration, triazolam
significantly decreased
sleep latency, increased the duration of sleep and decreased the
number of nocturnal
awakenings. However, after two weeks of consecutive nightly
administration, the drug's
effect on total wake time was decreased, and the values recorded in
the last third of the
night approached baseline levels. On the first and/or second night
after drug
discontinuance (first or second post-drug night), total time asleep,
and percentage of
time spent sleeping frequently were significantly decreased, and sleep
latency
significantly increased when compared to baseline (predrug) nights.
This effect is
referred to as "REBOUND" INSOMNIA.
The duration of hypnotic effect and the profile of unwanted effects
may be influenced by
the alpha (distribution) and beta (elimination) half-lives of the
administered drug and any
active metabolites formed. When half-lives are long, the drug or
metabolites may
accumulate during periods of nightly administration and be associated
with impairments
of cognitive and motor performance during waking hours. If half-lives
are short, the drug
and metabolites will be cleared before the next dose is ingested, and
carry-over effects
3
related to sedation or CNS depression should be minimal or absent.
However, during
nightly use and for an extended period, pharmacodynamic tolerance or
adaptation to
some effects of benzodiazepine hypnotics may develop. If the drug has
a very short
elimination half-life, it is possible that a relative deficiency
(i.e., in relation to the receptor
site) may occur