ABSTRACT
The inclusion of a separate chapter regarding the off-label use of prescription medications for insomnia in this book is a reflection of the peculiarities of the treatment of insomnia in the United States. The idiosyncratic nature of off-label prescribing in the field of insomnia is underlined by the absence of similar chapters devoted to off-label prescribing in standard textbooks on cardiac pharmacology, pulmonary pharmacology, etc. The need for such a chapter in a textbook on insomnia treatment is derived from statistics on physician prescribing that, until recently, revealed that off-label medications were prescribed preferentially for insomnia, in lieu of medications that are FDA approved for insomnia. As recently as 2002, the most-prescribed medication for insomnia in the United States was trazodone, which is approved by the FDA as an antidepressant, not as a hypnotic (1) (Table 1). It had not always been this way, as in 1986 the FDA-approved hypnotics triazolam, flurazepam, and temazepam were the leading choices among physicians (2). Somehow during the late 1980s and early 1990s, FDA-approved hypnotics were surpassed by trazodone. It is not entirely clear how and why this happened, but we can hypothesize the action of several factors including
a belief among prescribers that trazodone, other antidepressants, and later, some antipsychotics were reliably effective for treating insomnia;
a belief among prescribers that trazodone, other antidepressants, and later, some antipsychotics may be safer for patients than FDA-approved hypnotics;
a belief among prescribers that FDA-approved hypnotics would be needed or asked for by patients for a duration of time that outstripped their FDA-approved indication of use, thus exposing the prescriber to potential liability if there was an untoward event.
