Nitrazepam is not approved for marketing in the United States by the U.S. Food and Drug Administration. It is excreted into breastmilk in small amounts. Because of its long half-life of about 30 hours, it may accumulate in the serum of breastfed infants with repeated doses. Nitrazepam exerted significantly stronger sedative effects than diazepam, particularly when the respective serum concentrations were taken into account. This confirms that nitrazepam should be a more efficient sleeping drug, although diazepam also has considerable sedative-hypnotic action. Zopiclone and nitrazepam were more active than placebo on all tests of efficacy. In contrast with nitrazepam, zopiclone was devoid of effect on neurological function. In addition, the condition on awakening was better with zopiclone. Nitrazepam is a benzodiazepine compound with sedative properties. It acts in 30 to 60 minutes to produce sleep lasting six to eight hours. Nitrazepam is well absorbed with peak blood levels being achieved within two hours after administration. The concomitant use of sedative medicines such as benzodiazepines or related drugs such as nitrazepam with opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. In choice tests between placebo and drug, placebo was never preferred to diazepam; however, placebo was preferred to oxazepam on 21.4% of choice tests. Overall, these results extend previous experimental observations suggesting that diazepam has a higher abuse liability than oxazepam. An overdose of nitrazepam may lead to impaired breathing, dizziness, decreased cognition and balance, bluish nails and lips, slurred speech, and extreme somnolence, among others. In severe overdose, these symptoms may progress to a coma with a possibility of death.
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