Triazolam (U-33030), an investigational hypnotic drug, was evaluated in seven insomniac subjects in the sleep laboratory. The protocol consisted of 22 consecutive nights: four placebo nights for adaptation and baseline, two weeks of drug administration (0.5 mg triazolam) for short- and intermediate-term drug effectiveness, and four placebo nights for withdrawal effects. With short-term drug use, both sleep induction and sleep maintenance improved, with total wake time decreasing markedly--a 45 per cent decrease from baseline. At the end of two weeks of drug use, none of the efficacy parameters was significantly decreased from baseline; there was only a 17 per cent decrease in total wake time. Following drug withdrawal, sleep difficulty significantly increased above baseline levels. Two of the subjects experienced episodes of amnesia during the drug administration period. The per cent of REM sleep decreased significantly during both short and intermediate drug conditions. Following drug withdrawal, the per cent of REM sleep was similar to baseline. Slow-wave (stages 3 and 4) sleep was significantly decreased for both drug conditions; and following drug withdrawal, it returned completely to the baseline leve. These data indicate that triazolam is effective for short-term use, loses most of its effectiveness with intermediate-term use, and its withdrawal is followed by a significant sorsening of sleep. These findings are discussed in relation to the potential labeling and promotion of triazolam. Finally, the findings of amnesia associated with triazolam administration need to be more thoroughly evaluated.

Electroencephalography↗

PubMedDate not supplied

Effectiveness of temazepam with short-intermediate-, and long-term use: sleep laboratory evaluation.

The effectiveness of 30 mg temazepam (SaH 47-603) for inducing and maintaining sleep was evaluated in the sleep laboratory in six insomniac subjects under conditions of short-, intermediate-, and long-term drug administration. Administration of temazepam had no effect on sleep induction. In addition, effectiveness was not demonstrated for sleep maintenance: wake time after sleep onset was not significantly decreased on any of the three drug conditions, while the number of nightly awakenings was significantly decreased on all three drug conditions. Total wake time was decreased only slightly with short-term drug administration and was similar to baseline with intermediate- and long-term use. The percent REM sleep was essentially unchanged throughout the drug administration period. On the initial set of withdrawal nights, the per cent REM sleep was slightly but no significantly increased over baseline. The per cent slow wave sleep decreased significantly with short-, intermediate-, and long-term drug administration. After withdrawal, the percent slow wave sleep returned to baseline values.

Adult↗

PubMedDate not supplied

Effects of estrogen replacement therapy on rates of cyclic alternating patterns and hot-flush events during sleep in postmenopausal women: a pilot study.

The objective of this pilot study was to evaluate the effects of conjugated estrogens on the rates of cyclic alternating patterns of sleep (CAPS) and nocturnal hot flushes in symptomatic postmenopausal women. Seven postmenopausal or posthysterectomy women aged 45 to 60 years with nocturnal diaphoresis and/or hot flushes participated in this study. The study was conducted with a single-masked design using a matching placebo. The placebo baseline was followed by a 4-week, single-masked treatment of conjugated estrogens 0.625 mg taken 4 hours before bedtime. Each patient's sleep was monitored in the laboratory for 3 consecutive nights during placebo baseline and again for 3 consecutive nights after an at-home period of at least 24 days of estrogen replacement therapy. Estrogen therapy resulted in a statistically significant decrease in the overall number of hot flushes and the number of hot hot flushes associated with awakenings, as well as improvement in sleep efficiency and a reduction in the rate of CAPS. These data confirm earlier well-established reports that estrogens reduce the frequency of hot flushes and suggest that the frequency of nocturnal arousals decreases and sleep quality improves in conjunction with a reduction in the rate of CAPS.

Climacteric↗

PubMedDate not supplied

Lack of residual sedation following middle-of-the-night zaleplon administration in sleep maintenance insomnia.

The present randomized, double-blind, placebo and active-drug controlled, crossover study assessed residual sedation after zaleplon 10 mg, flurazepam 30 mg (as an active control), and placebo, taken during a nocturnal awakening in patients with sleep maintenance insomnia. Twenty-two healthy sleep maintenance insomniacs (11 men; mean age, 42 y) received zaleplon, flurazepam, or placebo after an experimental awakening 3.5 hours after bedtime on two consecutive nights in each of three conditions. Residual sedation was measured with sleep latency testing (5 and 6.5 h postdrug), digit symbol substitution, symbol copying, and subjective sleepiness by visual analog scale, each twice each morning. Zaleplon did not differ from placebo on any measure of residual sedation; flurazepam showed significant sedation on all measures. No residual sedative effects were detected 5 or 6.5 hours after ingestion of zaleplon during the middle of the night by sleep maintenance insomniacs.

Acetamides↗