Preference of insomniac patients between a single dose of zolpidem 10 mg versus zaleplon 10 mg.

We assessed the preference of insomniac patients between a single dose of 10 mg zolpidem or zaleplon, respectively, administered in random order on two consecutive nights. Fifty-three patients (mean age 52.2 years, 51% females) with a history of recurrent episodes of insomnia and currently complaining of difficulties in falling asleep were included into a randomized, double-blind, cross-over study by 12 general practitioners. After each night, the patients were asked to fill in a sleep questionnaire and visual analogue scales (VAS) to subjectively assess both the quality of sleep (in the morning) and the quality of the day (in the evening). After the second study night, patients' self-assessed preference was established through a drug preference questionnaire. 62% of patients preferred zolpidem, while 38% preferred zaleplon (p = 0.08). The quality of sleep items getting to sleep and quality of sleep were significantly more improved after zolpidem (p = 0.03 and p < 0.0001, respectively). On the VAS, subjective sleep quality was significantly better after zolpidem (p < 0.0001). Diurnal awakeness and quality of day life were satisfying in both groups, without significant difference. The subjective total duration of sleep was 8.0 h for zolpidem and 8.1 h for zaleplon (n.s.). Safety was good and similar between the two drugs. Insomniac patients tended to prefer zolpidem to zaleplon on both nocturnal and diurnal assessments. These results provide additional information for the physician's choice, based on the patient's preference for a given drug.

Effects on postural oscillation and memory functions of a single dose of zolpidem 5 mg, zopiclone 3.75 mg and lormetazepam 1 mg in elderly healthy subjects. A randomized, cross-over, double-blind study versus placebo.

OBJECTIVE: In elderly patients, both falls and impaired memory are considerable medical problems. Hypnotics, which are frequently administered to this patient group for the treatment of insomnia, should ideally not impair equilibrium or memory functions. This double-blind, randomised, four-way, cross-over study investigated the effects of frequently prescribed hypnotics from different classes on postural oscillation and memory under real life conditions. Zolpidem 5 mg, zopiclone 3.75 mg, lormetazepam 1 mg (i.e. usual starting doses in elderly) or placebo were administered at night to 48 healthy elderly volunteers aged 65 years or more. The study included four treatment periods separated by wash-out periods of at least 1 week. METHODS: Psychomotor tests up to 9 h or 10 h after drug intake included, for attention and body sway, clinical stabilometric platform (CSP) tests, simple reaction time (SRT), and the critical tracking test (CTT); for memory, the learning memory tasks (LMT) and the Sternberg memory scanning test (mean reaction time [MRT] and percentage of correct answers) were used. For subjective sleep evaluation the Leeds sleep evaluation questionnaire (LSEQ) and for sedation a visual analogue scale (VAS) were used. For safety evaluations, adverse events (AEs) were recorded. RESULTS: The results demonstrate that compared with placebo, the active drugs increased body sway (area eyes open and closed in the CSP); however, this effect disappeared after 5 h with zolpidem, while it disappeared only after 8 h with lormetazepam and zopiclone. All three drugs did not affect attention assessed by the SRT and CTT. Concerning memory, Sternberg MRT at 9 h was not significantly different up to 5 digits for all groups in comparison with placebo, while for 6 digits it was significantly increased with lormetazepam and zopiclone. In the LMT, an impairment of performance was observed with lormetazepam relative to both zolpidem and placebo. CONCLUSION: The safest compared drug with regard to body sway was zolpidem, because of its short-lasting effect. In addition, zolpidem did not show any significant effect on memory functions, in the present dose comparison.

Psychomotor and cognitive effects of piribedil, a dopamine agonist, in young healthy volunteers.

Piribedil is a dopamine agonist acting on D2 and D3 central nervous system dopamine receptors. This drug has been administered to 12 young healthy male volunteers (age 22 +/- 2 years) according to a single center randomized, double-blind, two ways cross-over, placebo controlled trial, including a washout period of one week. Placebo and piribedil were administered by a single intravenous infusion over 2 h (3 mg). Psychomotor performance and cognitive functions were assessed through a standardized and computerized psychometric tests battery and a continuous electroencephalogram (EEG) mapping. Piribedil improved simple reaction time (P=0.02), immediate (P=0.045 and 0.004), and delayed free recall (P=0.05), dual coding test (P=0.02) and increased theta and fast beta waves on the EEG (P < 0.05 and 0.001, respectively). No deleterious effect was observed on the tests exploring attention and concentration via the other procedures. It is concluded that a single intravenous perfusion of piribedil 3 mg improves alertness and the information processing speed within the central nervous system, in healthy volunteers.

Effects of a new slow release formulation of caffeine on EEG, psychomotor and cognitive functions in sleep-deprived subjects.

Caffeine is a widely-consumed psychoactive substance whose stimulant effects on mood, attention and performance are largely recognised. The central nervous system pharmacodynamic profile of a single oral dose of a new slow release (SR) caffeine formulation (600 mg) was assessed in a randomised, double-blind, crossover, placebo-controlled study. Twelve young, health, male, sleep-deprived (for 36 h) subjects were studied using EEG and various measures of psychomotor and cognitive functions, including critical flicker fusion (CFF), choice reaction task (CRT), tracking, continuous performance task (CPT), Stroop test, body sway and subjective evaluation (Stanford Sleepiness Scale). Caffeine significantly ( < 0/05) antagonised the detrimental effects of sleep-deprivation on EEG (i.e. produced a significant decrease in delta and theta relative power and a significant increase in alpha and beta (12-40 Hz) relative power) and psychomotor performance (significant increase in speed of reaction on the CRT and Stroop tests, significant decrease in body sway, significant increase in accuracy of the CPT and significant reduction in subjective sedation) compared to placebo. The effect peaked 4 h after dosing and was maintained until the end of sleep deprivation (i.e. 24 h after dosing). In conclusion, the present results demonstrate that a single dose of caffeine SR possesses alerting effects which are able to reverse the deleterious effect of 36 h sleep deprivation for at least 24 h. Copyright 2000 John Wiley & Sons, Ltd.