ABSTRACT
A long-term study of brotizolam (minimum 4 weeks: maximum 26 weeks) was carried out in hospitalized patients (29 to 95 years) who complained of sleep disturbance. 3.0% of the patients used 0.125 mg, 86.4% used 0.25 mg, and 10.0% used 0.5 mg daily. During the trial there was no evidence of tolerance. There were no symptoms of overdosage, physical and psychological dependency or withdrawal, and there were no interactions with the concurrently prescribed drugs. There were no changes in vital functions, haematology, or in the biochemical investigations of blood or urine which could be attributed to the drug.
Subject(s)
Azepines/therapeutic use , Hypnotics and Sedatives/therapeutic use , Sleep Wake Disorders/drug therapy , Adult , Aged , Azepines/toxicity , Clinical Trials as Topic , Drug Tolerance , Female , Hospitalization , Humans , Hypnotics and Sedatives/toxicity , Male , Middle Aged , Substance Withdrawal Syndrome , Time FactorsABSTRACT
Efficacy and tolerability of brotizolam (0.25 and 0.5 mg) were compared over a 6-day period with nitrazepam (5.0 mg) in middle-aged patients (less than 65 years) with sleep disturbances requiring medication. The study was double-blind and randomised with a cross-over design. Each preparation reduced sleep onset latency and frequency of awakenings, and improved quality and duration of sleep as well as subjective condition on awakening. Brotizolam 0.25 mg was found to be equally effective as 0.5 mg, and so the lower dose is recommended for the middle aged.
Subject(s)
Azepines/therapeutic use , Hypnotics and Sedatives/therapeutic use , Nitrazepam/therapeutic use , Sleep Wake Disorders/drug therapy , Adolescent , Adult , Aged , Clinical Trials as Topic , Double-Blind Method , Drug Tolerance , Female , Humans , Male , Middle Aged , Random AllocationABSTRACT
Efficacy of and tolerance to brotizolam were studied over 6 days in elderly patients (62 to 93 years) suffering from sleep disturbance requiring medication: 62.9% used 0.125 mg and 32.0% used 0.25 mg. Effectiveness of brotizolam was assessed as good-to-satisfactory in 87.1% of the patients. Efficacy of and tolerance to brotizolam were compared with nitrazepam in mainly elderly patients (56-91 years) with sleep disturbances requiring medication. Efficacy was assessed as good-to-satisfactory in 89.8% of patients with 0.125 mg brotizolam, 93.9% with 0.25 mg brotizolam and 95.9% with 5 mg nitrazepam. Patients reported improved sleep with all three preparations. The dose range of brotizolam recommended for the elderly is 0.125-0.25 mg, though for the vast majority of patients the lower dose will be sufficient.
