A post-marketing surveillance study was conducted in the Philippines in routine practice and involved 1482 patients treated with zolpidem (Stilnox R), an imidazopyridine hypnotic agent. The patient population was 53.24 percent women and 45.28 percent men with a mean age of 47 years old (18.42 percent were over 65 years old). Of the patients, 44.26 percent were treated with a zolpidem dosage of 10 mg/day and 35.96 percent, 5mg/day. The treatment duration range from 2 to 35 days and a mean of 8 days. All adverse events were collected through spontaneous reporting. Thirty-nine patients (2.6 percent) reported 79 adverse events 20 (1.3 percent) of them discontinued treatment. CNS (central nervous system) related adverse events accounted for 70 percent of the total events. The most common events were headache and drowsiness the next day in 0.88 percent and 0.81 percent of the total cases respectivelv. Dizziness, lack of concentration, restlessness, hallucinations, nightmares, incoherence and disorientation were observed in a lower proportion, with one episode of twitching of the lower extremities. No serious adverse event was reported and no new risk factors or at-risk populations were identified. The safety profile of zolpidem is thus consistent with its known pharmacological properties, the results of previous clinical trials, and the cumulative international experience gained with this short-acting hypnotic drug.
Human ; Male ; Female ; Middle Aged ; Adult ; Young Adult ; Adolescent ; SLEEP INITIATION AND MAINTENANCE DISORDERS ; ZOLPIDEM ;