ABSTRACT
The efficacy and safety of two dose levels of FS 205-397 (either 250 or 500 mg) were compared with the efficacy and safety of aspirin 650 mg and placebo in a 6-hour, single-dose, double-blind study in 161 patients who had undergone extraction of third molars. Each of the doses of FS 205-397, as well as aspirin, produced analgesia. However, the analgesic effects of both the 500 mg dose of FS 205-397 and aspirin were at times significantly better and more prolonged than those produced by the lower dose of FS 205-397. On the other hand, both doses of FS 205-397 had a significantly faster onset of action than aspirin. Side effects, reported by 17% of the 161 patients, did not differ significantly among the four treatment groups with respect to frequency, type, or severity. The most commonly reported side effects were nausea (7%) and drowsiness (6%). The results indicated that FS 205-397, administered in single doses of either 500 or 250 mg, is a safe and effective analgesic for the relief of pain following dental surgery, and may offer particular advantages in terms of onset of effects.
Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/pharmacology , Aspirin/pharmacology , Indoles/pharmacology , Pain, Postoperative/drug therapy , Adolescent , Adult , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Aspirin/administration & dosage , Aspirin/adverse effects , Double-Blind Method , Drug Administration Schedule , Female , Humans , Indoles/administration & dosage , Indoles/adverse effects , Male , Time FactorsSubject(s)
Amino Acids/pharmacology , Cycloleucine/pharmacology , Energy Metabolism/drug effects , Amino Acids/metabolism , Animals , Body Weight/drug effects , Diet , Feeding Behavior/drug effects , Glycoside Hydrolases/metabolism , Intestinal Mucosa/enzymology , Liver/enzymology , Male , Pancreas/enzymology , Rats , alpha-Amylases/metabolismABSTRACT
1 Temazepam was evaluated in a strictly defined insomniac patient population under sleep laboratory conditions. Two protocols were used: a short-term (26-night) and a long-term (54-night) protocol evaluated the efficacy of the drug administered at night at 15 mg (short-term study) and 30 mg (long-term study), respectively. 2 Temazepam seemed to be both safe and effective at doses of 15 and 30 mg with up to 5 weeks of ingestion. 3 Suppression of slow wave sleep was observed at the high dose, but no suppression of REM sleep, found in studies with other benzodiazepines, was noted. 4 No evidence was found for development of tolerance or rebound effects.
