Treatment of Insomnia in Primary Care
First created | 05/12/2009
Last edited |
- Ohayon MM, Caulet M, Arbus L, Billard M, Coquerel A, Guieu JL, Kullmann B, Laffont F, Lemoine P, Paty J, Pecharde JC, Vecchierini F, Vespignani H. Are prescribed medications effective in the treatment of insomnia complaints? J Psychosom Res 1999; 47:359-68
Most individuals complaining of insomnia consult a general practitioner at least once a year and prescription psychotropic drugs are the usual treatment reserved for these patients.
The prevalence of insomnia and its treatment have been widely investigated in the general population: approximately 10% of the French general population uses sleep-promoting medication, which is high in comparison to other countries. However, this issue has been given little attention in general practice.
Epidemiological studies in general practice are necessary to learn more about individuals with sleep complaints and the sort of medical help they receive. Information thus compiled will serve to better train physicians and, consequently, to improve the detection and treatment of sleep disorders.
The present study was conducted in France from October 1994 to May 1995. A total of 150 general practitioners were invited to take part in the endeavor. They were aged 43 on average and practiced general medicine for an average of 13 years.
Fifteen general practitioners were recruited from each of the ten French counties. A coordinator per county monitored the group of general practitioners. The study was made of two parts: an epidemiological part and a pharmaceutical trial:
- The epidemiological part required the physicians to interview all patients aged 15 or over who visited their office until they found three consecutive patients who complained of insomnia but were not under psychotropic treatment and three consecutive patients who complained of insomnia but were dissatisfied with their hypnotic treatment.
- These six patients were invited to participate in the pharmaceutical trial. Interviews were performed with the help of the Sleep-Eval expert system.
The Sleep-Eval system is a previously validated non-monotonic, level-2 expert system endowed with an inference engine and the capacity for causal reasoning (12). This system was specially designed to administer questionnaires and conduct epidemiological studies.
The system is designed to simulate the reasoning process of a sleep specialist. The causal reasoning mode enables the Sleep-Eval system to formulate a series of diagnostic hypotheses based on the responses provided by interviewees. The inference engine examines these hypotheses and confirms or rejects them on the basis of responses to further questions and subsequent deductions.
The system first applies a standard set of questions to the entire sample but then individualizes the interview as a function of the hypotheses it formulates. Concurrent diagnoses are allowed in accordance with the DSM-IV (13) and the International Classification of Sleep Disorders (ICSD-90) (14).
The system terminates the interview once all diagnostic possibilities are exhausted.
Interviews normally last about 15 minutes for subjects without sleep problems and from 45 to 150 minutes for subjects with insomnia. Obviously, the system does not need all that time to determine whether an individual has a sleep disorder or not. Depending on the complexity of the pathology, 5 to 15 minutes are necessary to determine which is the sleep disorder.
The system collect various information (sleeping habits, health care utilization, illnesses, medication consumption, etc.) that is not essential for the diagnosis but that are relevant for epidemiological purposes.
A more extensive description of the system can be found elsewhere (12).
The general practitioners collected data from all their patients regarding the following dimensions: sociodemographics; sleep-wake schedule (bedtime and morning wake-up time, sleep latency, total sleep time, extra hours slept on days off); sleep complaints (difficulty initiating or maintaining sleep, non-restorative sleep, daytime sleepiness); and intake of sleep-promoting medication (name of medication, frequency and duration of intake, sleep satisfaction, and subjective evaluation of medication efficacy).
Bivariate analyses were carried out with chi-square statistics. Logistic regression procedures (15) were also used to identify factors associated with sleep-promoting medication use. The cut-off point of entry (PIN) was fixed at .05 and the cut-off point of exclusion (POUT) at .10. Reported differences were significant at the .05 level. Analyses were performed with the SPSS computerized statistical package (SPSS 6.1).
Of the 150 general practitioners initially enrolled in the study, 127 respected the research protocol. The general practitioners collected information from 11,810 patients, of which 55.5% were women.
The age distribution of the sample was as follows:
- 12.7% were 15-24 years old,
- 18.4% were 25-34,
- 19.9% were 35-44,
- 16.5% were 45-54,
- 15.7% were 55-64,
- 12.2% were 65-74 and,
- 4.6% were 75 or over.
Mean age (s.d.) was 44.9 (±17.6) years for women and 46.3 (±17.1) years for men (p<.001).
At time of interview, 26.2% (95% CI: 25.4% to 27%) of all patients were either dissatisfied with their sleep (i.e., complaint of insomnia symptoms accompanied with sleep dissatisfaction) or used sleep-promoting medication.
- 16.0% (15.3% to 16.7%) of the sample was only dissatisfied with their sleep,
- 2.8% (2.5% to 3.1%) of the sample was both dissatisfied and taking sleep-promoting medication, and
- 7.4% (6.9% to 7.9%) of the sample consumed sleep-promoting medication and were satisfied with their sleep.
Use of sleep-promoting medication was reported by 10.1% (9.6% to 10.6%) of the sample (n=1194). For 70% of these cases, the drugs in question were benzodiazepines (zolpidem and zopiclone are not included in benzodiazepines).
The prevalence of medication consumption was:
- higher for women (11.4% [10.6% to 12.2%]; p<.001) than men (8.6% [7.9% to 9.3%]) and
- significantly increased with age: 4.9% (4.4% to 5.4%) of patients aged 15-44 reported taking such medication, compared with 14.5% (13.4% to 15.6%) of those 45-64, 16.8% (14.9% to 18.7%) of those 65-74, and 19.6% (16.3% to 22.9%) of those 75 or over.
TYPES OF MEDICATION
The various medications reported were classified under the following categories according to the French compendium of pharmaceutical specialties (Vidal):
- other psychotropics (e.g., antidepressants, neuroleptics, normothymics) and
- non-psychotropic medication (e.g., natural products, pain killers).
Hypnotics were used for sleep-enhancing purposes by 4.5% of the sample. Anxiolytics by 4.7%, other psychotropics by 0.5% of the sample, and non-psychotropic medication by 0.5% of the sample. Hypnotics and anxiolytics were the most frequently prescribed drugs for both men and women and across all age groups (Table 1).
|Types of medication Hypnotics||Anxiolytics||Other psychotropics||Non psychotropic medication|
|% [95% CI]||% [95% CI]||% [95% CI]||% [95% CI]|
|Men||3.9 [3.4-4.4]||3.8 [3.3-4.3]||0.5 [0.3-0.7]||0.4 [0.2-0.6]|
|Women||5.0 [4.5-5.5]||5.3 [4.8-5.8]||0.5 [0.3-0.7]||0.5 [0.3-0.7]|
|15-44||1.9 [1.6-2.2]||2.2 [1.8-2.6]||0.3 [0.2-0.4]||0.5 [0.3-0.7]|
|45-64||7.1 [6.3-7.9]||6.3 [5.5-7.1]||0.7 [0.4-1.0]||0.5 [0.3-0.7]|
|65-74||7.3 [6.0-8.6]||8.8 [7.3-10.3]||0.6 [0.2-1.0]||0.1 [0.0-0.3]|
|≥ 75||8.5 [6.1-10.9]||9.4 [6.9-11.9]||1.1 [0.2-2.0]||0.6 [0.0-1.3]|
FREQUENCY AND DURATION OF PSYCHOTROPIC MEDICATION INTAKE
Most consumers reported taking psychotropic sleep-promoting medication on a daily basis whereas this was the case for just over half of non-psychotropic drug users (Table 2).
|Types of medication||p value|
|Hypnotics||Regensburg||Other psychotropics||Non psychotropic medication|
|Frequency of intake (8)|
|3 to 6 days/week||10.2||11.5||0||22.0|
|2 days/week or less||8.1||6.8||1.7||24.0|
|Duration of intake (0)|
|< 12 months||30.1||19.9||28.8||44.4||<0.0001|
|1 to 5 years||26.5||25.5||32.2||20.4|
|> 5 years||13.3||20.8||11.9||3.7|
|Does not remember||30.1||33.9||27.1||31.5|
|Improvement of sleep quality (13)|
|No or little||14.4||19.8||11.9||40.4||<0.0001|
No gender differences emerged in this respect. However, the prevalence of daily psychotropic medication users increased with age. Accordingly, 94.1% of consumers aged 75 or over took sleep-promoting medication every day, compared with 92.1% of those 65-74, 82.1% of those 45-64, and 70.5% of those 15-44 (p<.001).
Where duration of intake is concerned, only a quarter of psychotropic sleep-promoting medication users had been taking their drugs for less than one year (Table 2). Moreover, duration of intake was found to be age-related: 34.9% of the oldest users (≥75 years of age), 41.1% of those 65-74 years of age, 46% of those 45-64 years of age, and 33.3% of those 15-44 years of age had been taking their medication for more than one year. Less than one-tenth (9.7%) of the oldest patients and more than one-sixth (15.8%) of those 65-74 years of age had been taking their medication for less than one year, compared with 23.3% of those 45-64 years of age and 43.2% of those 15-44 years (p<.001). Proportionally fewer anxiolytics users (19.9%) than other users (hypnotics 30.1%; other psychotropics 28.8%; non-psychotropics 44.4%) reported a duration of intake less than one year (p<.001).
Patients were asked whether use of sleep-promoting medication had brought about any change in their sleep. Most indicated that their sleep had improved immensely with medication (Table 2).
Perceived change was not gender-related but varied significantly as a function of age: Most of the consumers aged ≥75 (75.0%) and those aged 65-74 (77.5%) estimated their sleep had greatly improved with the use of medication. This was the case for 62.3% of patients aged 45-64 and 50.4% of those 15-44 (p<.001). Consumers of non-psychotropic medication were more likely to report little or no change in quality of sleep (Table 2).
Reported sleep latency was also compared according to medication use and age groups (Fig. 1).
Overall, sleep latency was longest in patients who reported to be dissatisfied with their sleep and that were not taking sleep promoting medication. However, most patients using a sleep promoting medication reported longer sleep latency than did subjects satisfied with their sleep and free from medication.
Similar conclusions can be made about sleep duration (Fig. 2). Patients who reported to be dissatisfied with their sleep and free from sleep promoting medication reported the shortest sleep duration, followed by patients using a sleep promoting medication. An exception was found with patients using other psychotropics (antidepressants or neuroleptics) as a sleep promoting medication.
Logistic regression was used to compare psychotropic sleep-promoting medication users against patients who reported being satisfied with their sleep. Psychotropic use was associated with being a woman, being 45 years of age or older, being dissatisfied with sleep latency, being dissatisfied with morning wake-up time, a sleep latency of at least 30 minutes, and short sleep duration (Table 3).
|Variable||OR [95% C.I.]|
|> 75||4.9 [3.7-6.0]|
|Morning wake-up time|
|< 30 minutes||1.0|
|30 to 59 minutes||1.8 [1.5-2.1]|
|> 60 minutes||2.8 [2.2-3.5]|
|< 4h30||5.9 [3.9-9.0]|
|4h31 to 5h59||2.2 [1.8-2.6]|
|6h00 to 8h29||1.2 [1.0-1.5]|
|8h30 to 9h59||2.0 [1.1-3.6]|
Finally, psychotropic users were compared with patients who claimed to be dissatisfied with their sleep but were not taking sleep-promoting medication. Again, psychotropics use was associated with age 45-64 (2.5 [2.1-3.1]), age 65-74 (3.1 [2.4-4.0]), age 75 or over (3.9 [2.7-5.6])). However, patients dissatisfied with their sleep were more likely to be dissatisfied with sleep latency (1.9 [1.5-2.3]), to be dissatisfied with morning wake-up time (1.8 [1.5-2.1]) and to have a short sleep duration of ≤4h30min (2.2 [1.6-3.1]) or of 4h31min to 6h (1.7 [1.4-2.1]). This model was also calculated by controlling for duration of psychotropic intake and for age groups. The significant variables were the same for all models except the one for subjects aged 75 or over, where dissatisfaction with morning wake-up time was the only variable that proved significant.
This study indicated that about one in ten patients in France seen in general practice consumes medication to enhance sleep. Similar figures were also found in the French general population (4,5,7). These drugs are for the most part anxiolytics and hypnotics and are usually taken on a chronic basis (i.e., one year or more).
This is true particularly of the oldest group of patients (≥75 years of age) where about one in five is a consumer. Quite surprisingly, most of the very old patients indicated that their medication greatly improved their quality of sleep when, in fact, multivariate model does not reveal significant differences with untreated sleep complainers on sleep duration and sleep latency. Same conclusions have been reached in retirement homes, where it has been noted that the sleep quality of elderly insomniacs treated pharmacologically is poorer than that of their non-treated counterparts (16).
Similarily, Englert and Linden (17) found that self-reported sleep duration and difficulties with sleep during the night did not discriminate between treated and untreated sleep complainers. It may be hypothesized that these patients used as reference to estimate medication efficacy either their worst insomnia period or withdrawal periods during which rebound insomnia can occur in the first few days. Another explanation may be found in the misperception of sleep quality during withdrawal periods, as was observed by Schneider-Helmert (18) in low-dose benzodiazepine-dependent insomniacs. These subjects claimed to sleep longer when they took sleeping pills than when in withdrawal, although no significant change actually occurred.
Similar conclusions were reached in a clinical trial that aimed to evaluate sleep patterns resulting from benzodiazepines prescribed by general practitioners for sleep-promoting purposes (19). It was found that there was an objective efficacy of the treatment in the first weeks but these effects could no longer be measured 4 weeks later. More surprisingly, the sleep complaint did not reemerge.
Physicians are nearly always the first to be blamed for the chronic and widespread use of sleep medication in society (20). However, the patients' attitude also plays a significant role in the matter.
In their study, Matalon et al. (21) reported that all the chronic hypnotics users identified by them in an urban clinic refused to use alternative treatments to their hypnotics even after being informed of the side-effects and the risk of addiction associated with long-term use of these drugs. This is not the case, however, in all studies. Indeed, Morin et al (22) reported that chronic insomniacs had a better perception of psychological intervention which is perceived to be more acceptable than pharmacological treatment.
According to Nicassio et al. (23), however, most physicians are disinclined to prescribe non-pharmacological treatments to patients with insomnia complaints unless they see a substantive number of patients with insomnia complaints in their practice. Those who do appear more familiar with insomnia assessment and diagnostic procedures are more likely to take the non-pharmacological approach to treating insomnia complaints.
This is further illustrated in the study of Mant et al. (24) who pointed out that general practitioners mostly used only benzodiazepines to treat insomnia complaints while non-drug approach was offered in about a third of patients with anxiety or depression. They concluded that with educational visits, a change was perceivable in the management of insomnia complaints, practitioners being more likely to offer alternative treatment to patients who newly complained of insomnia.
Studies have indicated that older users of benzodiazepines are at higher risk for accidents, such as falls and fractures (25,26), and for cognitive impairment (27). These dangers are in addition to the ever present risk of drug dependence and abuse. Most of the drugs used by the elderly are either hypnotics or anxiolytics, the safety and efficacy of which are not well documented with respect to this group (28).
Consequently, systematic studies of this segment of the population must be undertaken with a view to proving the safety of such drugs, comparing the relative merits of new hypnotic compounds, and determining the extent to which alternative therapies, such as sleep hygiene modifications, may improve the quality of sleep in the elderly. The above further underscores the importance of properly educating physicians regarding the consequences of long-term use of these drugs.
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