ABSTRACT
Twelve healthy volunteers were given either midazolam 15 mg or nitrazepam 5 mg for 7 consecutive days in a randomized cross-over trial. Self-assessment of sleep, mood or condition on awakening and adverse effects was performed, and the volunteers underwent evaluation of psychomotor performance. Hypnotic effect, judged by the classical sleep variables, showed that the drugs were more or less equal and were superior to placebo. Nitrazepam consistently produced an impaired condition on awakening and also clearly displayed a spectrum of adverse motor effects. Motor tests revealed impairment induced by both drugs, but, in the midazolam group the effect subsided during the trial period. Both drugs had a significant effect on memory, midazolam appearing to perturb certain memory functions to a greater extent than did nitrazepam. The residual plasma concentration of midazolam 11 h after treatment correlated well with the scores obtained in several of the psychomotor tests, whereas plasma nitrazepam levels were not related to performance in any subtest. When discontinued neither drugs, induced any rebound phenomenon. However, the adverse effects of nitrazepam appeared to be carried over into the adjacent placebo period.
Subject(s)
Benzodiazepines/blood , Nitrazepam/blood , Adult , Benzodiazepines/administration & dosage , Benzodiazepines/adverse effects , Female , Humans , Male , Memory/drug effects , Midazolam , Nitrazepam/administration & dosage , Nitrazepam/adverse effects , Perception/drug effects , Psychomotor Performance/drug effects , Sleep/drug effectsABSTRACT
A double-blind crossover trial was conducted in 42 outpatients of either sex in order to obtain information on the properties of 7.5 mg of zopiclone in a general practice setting compared with 2 mg of flunitrazepam. Each patient went through two periods of treatment, each period lasting 10 days. A comparison of the effect of the drugs showed a significant difference with regard to effectiveness and sleep latency favoring flunitrazepam. When patient's preferences were analyzed there was a highly significant difference favoring flunitrazepam both for effectiveness and tolerance. The side effects from both drugs were generally mild.
Subject(s)
Flunitrazepam/therapeutic use , Hypnotics and Sedatives/therapeutic use , Piperazines/therapeutic use , Sleep Initiation and Maintenance Disorders/drug therapy , Adolescent , Adult , Azabicyclo Compounds , Clinical Trials as Topic , Double-Blind Method , Family Practice , Female , Flunitrazepam/adverse effects , Humans , Hypnotics and Sedatives/adverse effects , Male , Middle Aged , Piperazines/adverse effects , Substance Withdrawal Syndrome/psychologyABSTRACT
A double-blind crossover trial was conducted in 42 outpatients of either sex in order to obtain information on the properties of 7.5 mg of zopiclone in a general practice setting compared with 2 mg of flunitrazepam. Each patient went through two periods of treatment, each period lasting 10 days. A comparison of the effect of the drugs showed a significant difference with regard to effectiveness and sleep latency favoring flunitrazepam. When patient's preferences were analyzed there was a highly significant difference favoring flunitrazepam both for effectiveness and tolerance. The side effects from both drugs were generally mild.
