The lack of market response seems modest but it's probably actually about fair.
This drug is not being pushed down a drug discovery pathway for registration with the FDA. Therefore, the financial implication of this trial is very small too.
There are many existing insomnia medications which are very effective, cheap and safe eg Zolpidem.
This product has to compete against them, so it seems unlikely it will ever be financially viable based on the low price of other sleeping medications.
The ZTL drug unfortunately had quite a high level of adverse events: 17 patients out of 24 is quite a lot.
Also - the sample size was small and they didn't use the standard FDA endpoint for insomnia (sleep latency onset) but instead created their own Insomnia Severity Index (ISI). I think we have to express some degree of conservatism and wonder why they chose not to use standard endpoints.
Let's consider this the first step of many and we look forwards to future clinical trials.
However, this trials confirms that Cannabis may make
you sleepier than placebo.
Nothing else beyond that at this stage.
