Hypnotics (sleeping pills) are relatively commonly prescribed. While exact numbers are difficult to come by, it has been estimated that 40 million or more Americans regularly use sleeping pills. Is there a risk from the regular use of sleeping sleeps? For reference, at the end of this article, I have included a list of the various commonly used types of sleeping pills.
Recently, the British Medical Journal (reference: Kripke DF, et al, BMJ Open 2012;2: e000850) published the results of a large scale study in patients belonging to a large Health Maintenance Organization (HMO). Since all the records of this HMO have been electronic since at least 2002, thus affording the opportunity to survey a large number of patients and their outcomes. The authors identified 12,465 patients with at least one order for a hypnotic medication. The authors then matched these by sex, age, smoking status, and observation period to 24,793 patients who never received an order for a hypnotic. After statistically adjusting for age, sex, smoking, body mass, ethnicity, marital status, alcohol use and prior cancer, the authors found that the death rate among those using hypnotics was over 4-fold greater than those not using hypnotics. The range of hypnotics was reasonably representative of what is available by prescription. Because the findings were so dramatic, several news stations picked up this study for coverage.
Indeed, the first author of this well-done study has become a crusader of sorts against the use of hypnotics and, along with others, believes that sleeping pills pose a risk for excess mortality. To address some of the concerns that have been raised in the public conscience regarding the use of sleep pills, I have decided to address this issue head-on and honestly describe what is known about the risks, and what is not known.
Did this study show that sleeping pills (all varieties) CAUSE death?
This study was what is called a "retrospective" study, that is, a study looking back. Retrospective studies are a good place to look for things, but since conditions are often not able to be well controlled, they may not be able to say what caused what. Indeed, for the study at hand, while very well done, the study could not (and did not) claim to have demonstrated a CAUSAL relation. Indeed, the patients in the hypnotic group also had a higher incidence of asthma, cardiovascular diseases (including coronary disease, cerebrovascular disease, hypertension, heart failure, peripheral vascular disease), chronic kidney diseases, diabetes, obesity, and chronic obstructive lung disease. All these conditions are well known to be associated with increased mortality and with insomnia, for which it is logical to assume that doctors might prescribe sleeping pills.
So, as the authors of this study noted in their discussion of the results, the question of causality cannot be claimed, and these (and other similar studies) may have simply observed that people with chronic illness are more likely to have insomnia (and this is certainly true) and, of course, more likely to die. The cause of death was generally not available on the database.
How safe are sleeping pills?
Of course, sleeping pills like any other pills all have potential side effects. However, the side effects are less common, and generally manageable, for the newer classes of medications. Some of the older types (especially the barbituates) are well known to cause depression of the respiratory system, especially in larger doses. While the "benzos" also suppress respiration, they do less frequently. All sleeping pills are potentially dangerous when combined with alcohol. Some sleeping pills can have depression as a side-effect. Again, there were no data on how many of the deaths were suicide. All the sleeping pills can be associated with problems with thinking and motor skills the next day. That is why for patients taking the longer acting sleeping pills ("Lunesta" for example), we often ask that at least 8 hours be allowed for sleep, and at follow-up visits, we always assess whether patients are having "carry-over" effects. Some of the sleeping pills may make sleep apnea worse (especially the barbs and benzos), and this could in turn be a risk for car accidents or cardiovascular disease. Some of the sleeping pills (Ambien for one) have been shown to increase reflux of acid from the stomach. This could irritate the upper respiratory tract and potentially be a source of infection.
On the other hand, the FDA trials allowing the prescription sleeping pills to come to market, while tightly controlled, and not involving millions of people did not demonstrate increased mortality. Most of these studies do show that, at least in the short term, sleeping pills may be associated with improved sleep quality and daytime functioning.
Tolerance and addiction are always a potential with sleeping pills. This was especially a problem with heavy use of barbs and benzos. With the newer classes (the non-benzos and others) this is less of a problem for most people.
What is the general approach to the treatment of insomnia?
This is actually a complex question. This is because insomnia is not a disease (usually), but the result of something else. Causes include physical ailments (most chronic ailments can cause insomnia), pain, psychologic stress (acute and chronic), other medications, "organic" sleep disorders (for example sleep apnea, restless legs syndrome), and poor sleep habits. The general approach is to find out how long the insomnia has been going on (if more than 1 month it is called "chronic"). We also like to find out if there is something that triggered insomnia. We also ask about the patient's medical and mental health history as well as medications. The social circumstances are extremely important. For example if a patient works 3 nights a week, it is not surprising that he/she cannot stay awake during the night shift, and cannot sleep during the day. We look for signs of "organic" sleep disorders. Finally, we obtain a detailed history of the patient's bedtime schedule, sleep habits and sleeping environment.
Sometimes, the cause of the insomnia pops right out at you. For example, if a patient takes a 3 - 4 hour nap in the afternoon or evening, it is not surprising that they cannot fall asleep at a reasonable hour. At other times the sleep specialist must "dig" a bit more. Sometimes (about half the time) an organic sleep disordered is suspected of playing a large role. In these cases, an all-night sleep study may be useful. Sometimes, patients keep diaries which may be very informative. So, you see, the issue rather complex.
As noted elsewhere on our website, treatment options depend on the underlying cause of insomnia, the presence of other problems, and individual patient preferences. We always advocate treatment of any underlying cause (be it in the physical or mental health realm). We always advocate optimization of the patient's sleep schedule and sleeping habits (sometimes this takes a lot of work). In many cases we are faced with the need to choose some therapy, either temporary or long-term depending on the case for symptomatic relief. Insomnia is a very distressing symptom, and has real implications for functioning during the day, and treating the symptom is definitely called for while the other issues are addressed.
The two major categories of symptomatic relief for insomnia include sleeping pills, and cognitive-behavioral therapy (described elsewhere in this website). Each of these approaches has its own advantages and disadvantages. For long-term treatment of insomnia as a symptom, we prefer a behavioral approach (if possible), but there are some patients for whom long term sleeping pills are acceptable. We certainly advocate an individual approach to treatment. Merely throwing pills at a patient is usually not the answer, certainly for a chronic problem.
What is the role of sleeping pills for treatment of insomnia?
Hypnotics are tools. Like any tool, there are indications for use, and types. Hypnotics are often chosen on the basis of how fast they take action and how long their action lasts. For example, a short acting, rapid onset hypnotic may be indicated when the problem is going to sleep, where for sleep maintenance, a longer duration of action may be indicated. Also, interactions with other medical problems or medications must be taken into account.
For short term insomnia (jet lag, temporary life stressor), sleeping pills may be taken for a few days if needed, without a problem. Hypnotics may be useful for nightshift workers who have trouble sleeping in the day after a shift (combined, of course with other coping strategies). Patients who are chronically insomniac do need symptomatic treatment and choices (above) exist. The particular choice for a particular patient must be made on an individual basis, taking all the relevant factors into account. There is no "one size fits all" approach and the appropriate treatment plan must be made by the patient with his/her physician or sleep specialist.
Should I throw away my sleeping pills?
There is no need to panic, or to toss the sleeping pills in the toilet. There is no certain evidence that sleeping pills CAUSED the excess mortality observed, rather it is likely that conditions associated with mortality and that cause insomnia led physicians to prescribe sleeping pills. However, as noted above, alternatives exist. There is no reason to accept a lifetime on sleeping pills as a "given." Other avenues for evaluation and treatment of insomnia certainly can be explored with a health care practitioner knowledgeable in this terrible problem. Before throwing the pills away, patients on chronic sleeping pills should have a frank discussion with their health care practitioner about the issues. The practitioner and the patient can then make rational decision that suits that particular individual patient's needs.
Types of hypnotics
The term "hypnotic" roughly refers to what are commonly called "sleeping pills." These are medications taken prior to the sleeping period that are an aid to falling asleep and/or maintaining sleep. There are various types of medications out there. They differ in class, onset of action, duration of action, and potential risks. Here are some of the more common types. They are listed as the generic name first, and the brand name after. Most are available generically. These lists are not meant to be all-inclusive, but only representative.
See Dr. Scharf's interview on ABC World News about the dangers of sleeping pills.