Posted: February 15th, 2022

Great Britain and Anthony Kales at UCLA

Ian Oswald in Great Britain and Anthony Kales at UCLA were the first to study hypnotics in terms of all night’s sleep laboratory testing that began when barbiturates were really the only thing available. It was clear that barbiturates were addicting and that they were dangerous. This was about the time when the very first Benzodiazepine hypnotic was marketed by the Roche company, and it was called Flurazepam. Dalmane was more effective than say, Nembutal. It was certainly much, much safer and tended not to lose its efficacy over a relatively short period of time. Now, nobody was studying sleep every night for months. Testing was done. Dalmane first of all, did not suppress REM sleep. So one of the things was it didn’t suppress REM sleep. Well, it does suppress somewhat at a higher doses, but at any rate, it induced sleep, it was safe, didn’t suppress REM sleep. And what they missed entirely in those early days was if Dalmane had a long-acting active metabolite; sedation continued in the daytime.

The second generation of benzodiazepine hypnotics was marketed by the Upjohn company, and it was Triazolam. The first big breakthrough in hypnotic efficacy research was the use of the sleep laboratory. The second big breakthrough frankly, was the principle that you have 24 hour day and if sleep is improved at night, then alertness must be improved during the day. Comparing Dalmane to Halcion, it was like day and night. Halcion improved sleep and improved daytime alertness using mobile sleep latency test. Dalmane improves sleep but it impaired daytime alertness. 

Meanwhile, a new compound was being developed again in France, which has a trade name, Ambien, and it was an imidazopyridine non-benzodiazepine. Although it apparently was a benzodiazepine agonist, it was to some extent an improvement. It did not produce any withdrawal effects. With Halcion when it was first marketed, the FDA did get reports of side effects, but certainly there was less when Ambien was introduced. I think it has passed the test of time in that regard. It just hasn’t been any notoriety at all. 

My position is that a bottle of sleeping pills in the medicine cabinet is like a fire extinguisher in the basement. There are times when you need to get sleep and you can’t. Lots of stories around the country, some very tragic where they had terrible insomnia and then some tragic consequence due to the excessive daytime sleepiness. Meanwhile, physician refusing to prescribe.

It is now known of course, that there is a circadian rhythm of melatonin secretion in constant dim light. There’s a specific period of onset of melatonin secretion under the control of the biological clock and then it is in the system all night long. It’s suppressed by light. There’s a level of melatonin through the night and then it decreases in the daytime. Now one thing it is known, there are melatonin receptors in the Suprachiasmatice nucleues. The biological clock can be– it’s time can be shifted by the administration of melatonin for indivuduals who have insomnia due to the failure of synchrony between the daytime schedule and the circadian rhythm. You can shift the clock by giving melatonin at times when the ordinarily isn’t present. 

Many people feel that melatonin is also sedating and that in some way, it sort of initiates the whole sleep process. I think that studies in which it has been used purely as a hypnotics have been, in my opinion, somewhat inconclusive. It is certainly not a potent sedative. Though, the main reason for the widespread use of melatonin is number one; you don’t need a prescription, it’s sold in health food stores; it’s a normal hormone so that it ought to be very safe; apparently it is not totally dose dependent so very small dose produces for some people at least the desired effect. But I think we have more to learn about melatonin

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