Throughout these generations of drugs, the “effective” part has been left essentially up to improvement of symptoms. This seems simple enough – what more is needed than the patient’s experience of improvement? Of course symptom resolution is important, but it cannot be the only standard. If it were, then why would physicians counsel patients against using alcohol (or opium, for that matter) to assist with sleeplessness? Well, hopefully that answer also seems obvious: because those substances carry substantial potential risks. Alcohol and opiates can actually make sleep objectively worse, even if a person feels subjectively that they slept “better”. So, clearly, we need to consider any drug remedy for sleep as a risk-benefit balance. And surely some patients will accept a purely subjective sense of “better” sleep, even if objective sleep is unchanged (or even worse), and even if substantial side effect risk is incurred, because the symptom relief is so important to the patient.
What we must avoid is the sense that this is an “easy” question, and we must not overlook the need to navigate the risk-benefit balance for each patient individually. It is not at all easy to judge the objective health benefits of sleeping pills. In fact, all published long-term studies of sleeping pill use and medical health have shown only risk . And while I have been critical of some of that literature , such a lopsided literature should give us pause, especially since I am certain that many patients may be taking comfort in the thought that their treatment is improving their health. Is it? Even the health risks (forgetting whether medications help them) of chronic insomnia have been strikingly questioned by the only large study of insomnia that actually measured objective sleep . In that study, only those with both insomnia symptoms and objective short sleep time carried medical and psychiatric risk over the 10 year time-frame. Insomnia without objective short sleep, or objective short sleep without insomnia, did not carry these risks. Physicians do not routinely test the objective sleep in patients with chronic insomnia, though increasing data suggests we should be doing more of this – even as insurance increasingly restricts laboratory polysomnography in favor of simplistic sleep apnea kits that don’t measure sleep at all. Clearly, we cannot consider insomnia a simple disorder, nor can we consider drug therapy a simple solution. Even the most up-to-date review of the literature describes the evidence as “weak”, and offers mainly consensus (opinion) advice . One thing is certain: we have a lot of work to do in this field.
 Kripke (2016) Hypnotic drug risks of mortality, infection, depression, and cancer: but lack of benefit.
 Bianchi et al (2012) Hypnotics and mortality risk. J Clin Sleep Med. 8(4):351-2.
 Vgontzas et al (2013) Insomnia with Objective Short Sleep Duration: the Most Biologically Severe Phenotype of the Disorder.
 Sateia et al (2017) Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 13(2):307-349.