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 ;

OBJECTIVES: To establish an LC-MS/MS method based on single hair micro-segmental technique, and verify the detection of 42 psychoactive substances in 0.4 mm hair segments. METHODS: Each piece of single hair was cut into 0.4 mm segments and extracted by sonication and the segments were immersed in dithiothreitol-containing extraction medium. Mobile phase A was the aqueous solution containing 20 mmol/L ammonium acetate, 0.1% formic acid, and 5% acetonitrile. Mobile phase B was acetonitrile. An electrospray ionization source in positive ion mode was used for data acquisition in multiple reaction monitoring (MRM) mode. RESULTS: The 42 psychoactive substances in hair had a good linear relationship within their respective linear ranges (r>0.99), the limits of detection were 0.2-10 pg/mm, the limits of quantification were 0.5-20 pg/mm, the intra-day and inter-day precisions were 1.5%-12.7%, the intra-day and inter-day accuracies were 86.5%-109.2%, the recovery rates were 68.1%-98.2%, and the matrix effects were 71.3%-111.7%. The method was applied to hair samples collected from one volunteer at 28 d after a single dose of zolpidem, with zolpidem detected in 5 hairs was 1.08-1.60 cm near the root tip, and the concentration range was 0.62-20.5 pg/mm. CONCLUSIONS The micro-segmental technique of single hair analysis can be applied to the investigation of drug-facilitated sexual assault cases.
Humans ; Chromatography, Liquid/methods* ; Zolpidem ; Tandem Mass Spectrometry/methods* ; Hair ; Acetonitriles ; Chromatography, High Pressure Liquid

BACKGROUND: Difficulty of sleeping is a predominant complaint among the elderly occurring in 12-25 percent of healthy seniors. Typical response of most physicians is to provide medications like benzodiazepines. Owing to the side effects of these drugs, alternatives to pharmacologic treatment such as music therapy abound. Music therapy is safe, affordable and may complement other non-pharmacologic interventions, yet there is paucity of evidence from controlled trials to support its efficacy.
OBJECTIVE: To determine the efficacy of music therapy in improving quality of sleep among elderly patients with primary insomnia as compared to 1) Zolpidem and 2) Sleep hygiene using the Pittsburgh Sleep Quality Index (PSQI).
METHODOLOGY: In a randomized controlled trial involving 78 male and female subjects aged 60-80 with primary insomnia seen at the Family Medicine Clinic, three interventions were employed: Treatment A (Music Therapy), Treatment B (Sleep Hygiene) and Treatment C (Zolpidem). To determine improvement in sleep quality, subjects answered the PSQI questionnaire at baseline and at 14 days after intervention. Comparison of the mean scores before and after intervention and the mean change in the Global PSQI and its sleep components was done to assess the efficacy of music therapy. An intention to treat analysis was done.
RESULTS: Of the 90 participants enrolled, 78 completed the treatment protocol (Sleep hygiene = 27, Zolpidem = 24 and Music therapy = 27). Twelve were lost to follow-up. Baseline characteristics showed no significant differences among the three interventions in terms of age, gender, marital status, education, concomitant illnesses and insomnia severity. After 14 days of intervention, significant improvement in sleep quality with regard to 4 important parameters (latency, duration, efficiency, overall sleep quality) was consistently found in all the three intervention groups (p <.05). A two week music therapy regimen increased sleep duration from 5.19 +/- 1.24 hours to 6.0 +/- 1.08 hours (p = .007). For all the three interventions, time to sleep onset significantly decreased from baseline (p = .000). Music therapy for two weeks significantly reduced the amount of sleep from 65.1 +/- 48.7 minutes to 32.7 +/- 12.9 minutes (p = .000). Overall subjective sleep quality rating improved across the three regimens (p < .05). For Music therapy, sleep quality rating improved from 1.48 +/- 0.72 to 0.71 +/- 0.46 post intervention (p = .000). Furthermore, music therapy is better than zolpidem in terms of subjective sleep quality (p = .017). Scores on the Global PSQI showed that there is no statistically significant difference between the Sleep hygiene and Zolpidem groups (p = .622), between the Sleep hygiene and Music therapy groups (p = .989) and between the Zolpidem and Music therapy groups (p = .540).
CONCLUSION: This controlled study conveys that music therapy is as efficacious as pharmacologic therapy and sleep hygiene in improving sleep quality. Instituting music therapy for 14 days improved sleep latency, duration, efficiency and overall sleep quality. It provided promising effect as a short term management alternative to primary insomnia. Its sustained effect has to be investigated.

Human ; Male ; Female ; Aged 80 And Over ; Aged ; Middle Aged ; Sleep Initiation And Maintenance Disorders ; Zolpidem ; Music Therapy ; Benzodiazepines ; Sleep Hygiene ; Sleep ; Pyridines

The Z-drugs (zolpidem, zopiclone, and zaleplon), as the innovative hypnotics, have an improvement over the traditional benzodiazepines in the management of insomnia. Z-drugs have significant hypnotic effects by reducing sleep latency and improving sleep quality, though duration of sleep may not be significantly increased. As benzodiazepines, Z-drugs exert their effects through increasing the transmission of γ-aminobutyric acid. Z-drugs overdose are less likely to be fatal, more likely would result in poisoning. Z-drugs can be detected in blood, urine, saliva, and other postmortem specimens through liquid chromatography-mass spectrometry techniques. Zolpidem and zaleplon exhibit significant postmortem redistribution. Z-drugs have improved pharmacokinetic profiles, but incidence of neuropsychiatric sequelae, poisoning, and death may prove to be similar to the other hypnotics. This review focuses on the pharmacology and toxicology of Z-drugs with respect to their adverse effect profile and toxicity and toxicology data in the field of forensic medicine.
Acetamides/poisoning* ; Azabicyclo Compounds/poisoning* ; Drug Overdose ; Forensic Medicine/trends* ; Forensic Toxicology/trends* ; Humans ; Hypnotics and Sedatives/poisoning* ; Piperazines/poisoning* ; Pyridines/poisoning* ; Pyrimidines/poisoning* ; Sleep Initiation and Maintenance Disorders/drug therapy* ; Zolpidem