Country: Canada
Language: English
Source: Health Canada
NITRAZEPAM
SANDOZ CANADA INCORPORATED
N05CD02
NITRAZEPAM
10MG
TABLET
NITRAZEPAM 10MG
ORAL
100/500
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0114345002; AHFS:
CANCELLED POST MARKET
2018-08-01
_Sandoz Nitrazepam_ Page 1 of 20 PRODUCT MONOGRAPH T\C SANDOZ NITRAZEPAM (Nitrazepam BP) 5 mg and 10 mg Tablets Hypnotic and Anticonvulsant Sandoz Canada Inc. 145 Jules-Léger Boucherville, QC, Canada J4B 7K8 Date of Revision : August 5, 2011 Control # 148130 _Sandoz Nitrazepam_ Page 2 of 20 T\C SANDOZ NITRAZEPAM Nitrazepam BP Tablets Hypnotic and Anticonvulsant ACTION AND CLINICAL PHARMACOLOGY Nitrazepam is a benzodiazepine with hypnotic and anticonvulsant properties. In sleep laboratory studies nitrazepam decreased sleep latency, increased total sleep time and decreased awake time. There is delay in the onset, and decrease in the duration of REM sleep. Nitrazepam is reported to significantly decrease stage 1, 3 and 4 sleep and to increase stage 2. Following discontinuation of the drug, REM sleep rebound has been reported in some studies. Nitrazepam has been shown to raise the seizure threshold. GENERAL BENZODIAZEPINE CLINICAL PHARMACOLOGY 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 metabolite 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 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 at some point in the interval between each night's use. This sequence of events may account for two clinical findings reported to occur after several weeks of nightly use of rapidly eliminated benzodia Read the complete document