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Effects of Benzodiazepines on Sleep and Wakefulness

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Effects of Benzodiazepines on Sleep and Wakefulness Br. J. clin. Pharmac. (1981), 11, 31S-35S EFFECTS OF BENZODIAZEPINES ON SLEEP AND WAKEFULNESS T. ROTH, F. ZORICK, JEANNE SICKLESTEEL & E. STEPANSKI Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, Michigan The differential effects of short and long acting benzodiazepines on sleeping and waking behaviour are discussed, with particular reference to hypnotic efficacy, and their effects on the structure ofsleep and daytime function. Introduction THE evaluation of any drug requires an understand- et al., 1979), and triazolam (Metzler et al., 1977) have ing of the conditions in which it is going to be used come into clinical use. The present report will present clinically. In the case of hypnotics, the most appro- the differential effects of short- and long-acting ben- priate use is symptomatic relief for the complaint of zodiazepines on sleeping and waking behaviour. insomnia. To understand fully the safety and efficacy ofthese drugs, we must first be aware of the constella- tion of symptoms associated with the complaint of Sleep parameters insomnia, as well as what these drugs do to each of these symptoms. In evaluating the effects of hypnotics on sleep, two Insomnia is a complaint. Although all of the types of parameters should be considered. The first aetiological factors which give rise to this symptom set of parameters deal with hypnotic efficacy and are not currently well understood, there is an accepted include measures such as latency to sleep onset, total diagnostic system for the various disorders associated sleep time, number and duration of awakenings, and with disturbed nocturnal sleep (Association of Sleep sleep efficiency. The second set of parameters deal Disorder Centers, 1979). Whenever one of these dis- with sleep staging and include measures of the orders is diagnosed, the specific disorder should be amount of time spent in various sleep stages (that is 1, treated directly. However, when no diagnosis can be 2, 3-4 and REM), as well as the latency to stages 3-4 determined or if the insomnia is situational and/or and REM from sleep onset. time-limited, the problem can and should be dealt The differential effects of short- and long-acting with symptomatically. An important point in dealing benzodiazepines on hypnotic efficacy are illustrated with the symptomatic relief of insomnia is that in- by a study comparing estazolam (short-acting) and somnia is not simply difficulty with sleep or insuf- flurazepam (long-acting). A group of 18 insomniacs ficient sleep. Most insomniac patients feel that the were studied in a 14 d protocol. The first night served quality oftheir life, as reflected in their ability to work as an adaptation night, on nights 2-4 baseline record- productively and interact effectively, is seriously ings were obtained, on nights 5-11 active drug was compromized by their difficulties with sleep. Thus, in administered (nine subjects received estazolam 2 mg treating insomniac patients, a clinician must deal with and nine received flurazepam 15 mg), and finally, the patient's daytime functioning as well as their recovery was evaluated on nights 12-14. On all non- nocturnal sleep. Similarly, in evaluating hypnotic active drug nights placebo was administered, and the drugs, their effects on sleep as well as on daytime entire study was carried out using a double-blind functioning must be determined. procedure. The effects of flurazepam and estazolam In the symptomatic treatment of insomnia, benzo- on total sleep time and number of awakenings are diazepines are currently the drugs of choice. Unlike presented in Table 1. As can be seen, both of these the barbiturates, benzodiazepines do not produce compounds significantly decreased the number of tolerance with nightly usage, and there is little risk of awakenings and increased total sleep time with one death associated with overdosing. Most of the benzo- week of nightly administration. However, only the diazepines which were first developed, such as flura- short-acting compound showed significant hypnotic zepam, are long-acting compounds (Kaplan et effects with only a single night of administration. al., 1973). Recently, short-acting benzodiazepine With long-acting compounds, multiple nights of drug hypnotics, with half-lives of less than 12 h, such as administration, and therefore drug accumulation, are estazolam (Nakajima et al., 1971),, temazepam (Roth necessary to achieve significant hypnotic efficacy. 0306-5251/81/130031-05 $01.00 ) Macmillan Publishers Ltd 1981 32S T. ROTH, F. ZORICK, JEANNE SICKLESTEEL & E. STEPANSKI Table I The effects of estazolam and flurazepam on total sleep time and number of awakenings Condition: Baseline FirstDrug OverallDrug Recovery Study night: 2-4 5 5-11 12-14 Flurazepam 15mg Total sleep time 397 409 433t 428* Number of awakenings 13 11 9* 8t Estazolam 2 mg Total sleep time 382 436t 428t 372 Number of awakenings 11 5t 5t 7* * Significantly different from baseline P<0.05; t significantly different from baseline P<0.01. Similarly, drug accumulation is demonstrated by also of interest to note that although neither com- hypnotic efficacy with flurazepam on the withdrawal pound significantly affected the latency to stage 3-4, nights and a return to baseline with estazolam. Thus, the long-acting drug significantly suppressed the total longer-acting drugs like flurazepam are characterized percentage of stage 3-4. by drug build-up for the first couple of active drug Another major difference between the two drugs nights and a carry-over of drug activity into the re- was their effect on sleep stages during the post-drug covery period. Short-acting drugs like estazolam pro- recovery period. Ketazolam sinificantly affected the duce their maximal effect with a single night of latency to REM, percentage REM and percentage administration and a return to baseline as soon as 34 on the first 3 recovery nights. Triazolam, on the drug is discontinued. other hand, did not have a significant effect on any of The differential effects of short- and long-acting these parameters during the recovery period. This benzodiazepines on sleep stages are illustrated by two indicates that the longer half-life ofketazolam is asso- studies carried out in-our laboratory. In the first study, ciated with a build-up of active drug which in turn is 0.5 mg of triazolam, a benzodiazepine with a half-life associated with a carry-over of sleep suppression for of 4.5-5 h (10) was administered to eight insomniac several days after discontinuation of the drug. subjects for 14 consecutive nights. Ketazolam, a ben- zodiazepine with a half-life of 14 h (4), was admin- istered to eight insomniac subjects for 7 consecutive Performance parameters nights in a second study. Both studies were double- blind and each had, in addition to the period of drug Since patients who complain of insomnia also com- administration, a baseline (placebo) and recovery plain of disturbed daytime functioning and since (placebo) period. These results are presented in sedative hypnotics are known to affect daytime func- Table 2. tioning, their proper evaluation requires examination Both triazolam and ketazolam significantly in- of their daytime effects. The evaluation of daytime creased the latency to REM sleep in comparison with functioning should include a battery of several dif- baseline. However, only ketazolam administration ferent types of tests. A battery of different tests is was associated with a significant decrease in the per- desirable as different drugs may affect different centage of REM. These findings demonstrate that waking functions. Also, the myriad of daily activities although both compounds affected REM latency, the (for example, driving, problem solving, and so on) drug with the longest half-life significantly suppressed routinely performed cannot be evaluated using a the total percentage of REM across the night. It is single test. An ideal battery should consist of the Table 2 Percentage change from placebo condition using ketazolam and triazolam Ketazolam Triazolam Drug days Drug days Recovery days Drug days Drug days Recovery days 17-3 5-7 1-3 1-3 12-14 1-3 Percentage REM -21 * -22* -11* -13 -09 0 Latency to REM +61 * +64* +30* +56* +72* +04 Percentage stage 3-4 -07 -35* -29* +13 +08 +03 Latency to stage 3-4 +10 +21 +33 +21 +25 +34 * Significantly different from placebo P<0.05. BENZODIAZEPINES & SLEEP AND WAKEFULNESS 33S +1.0 2:00 am 8:30 am 9:00 pm 3.5 h after drug 10 h after drug 22.5 h after drug +0.5 S placelbo levFel 0 T. F30 l -0.5 ~~~~~~T2 F30 -1.0 | | ~F30 F30 -1.5 -2.0 l T.50lll -2.5 T.25 = Triazolam .25 mg F30 = Flurazepam 30 mg S = Secobarbital 100 mg T.50 = Triazolam .50 mg F15 - Flurazepam 15 mg Figure 1 Effects oftriazolam 0.25 mg (T.25) and 0.50 mg (T.50), fiurazepam 30 mg (F30) and 15 mg (Fl 5), and secobarbital 100 mg (S) on performance expressed as Z scores. following types of tasks: simple motor, gross co- and 2100 (22.0 post-drug ingestion). The perfonnance ordination, reaction time, cognitive, vigilance, and battery consisted of: (1) pursuit rotor, a test of eye- memory. This battery of tests should be performed hand coordination in which subjects must keep a several times in the 24 h following drug ingestion. The stylus in contact with a rotating disk; (2) purdue first test should be performed at a time when peak pegboard, another test of eye-hand coordination in blood levels of the drug are expected so as to gain which subjects are required to place pegs onto a information about the maximum degree of impair- board; (3) continuous arithmetic, a test of simple ment that can be anticipated. The next testing should arithmetic ability (addition and subtraction be performed in the morning to determine if patients problems); (4) digit symbol substitution test, a test of taking the medication experience any morning cognitive ability in which subjects are required to "hang-over".
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