STUDY OBJECTIVES: To assess hypnotic self-administration and likelihood of dose escalation over 12 months of nightly use of zolpidem versus placebo in primary insomniacs. DESIGN: Randomized, double-blind, placebo-controlled, clinical trial. SETTING: Outpatient with tri-monthly one-week, sleep laboratory assessments. PARTICIPANTS: Thirty-three primary insomniacs, without psychiatric disorders or drug and alcohol abuse, 32-64 yrs old, 14 men and 19 women. INTERVENTIONS: Participants were randomized to take zolpidem 10 mg (n = 17) or placebo (n = 16) nightly for 12 months. In probes during month 1, 4, and 12, after sampling color-coded placebo or zolpidem capsules on 2 nights, color-coded zolpidem or placebo was chosen on 5 consecutive nights and 1, 2, or 3 of the chosen capsules (5 mg each) could be self-administered on a given choice night. RESULTS:Zolpidem was chosen more nights than placebo (80% of nights) and number of nights zolpidem was chosen did not differ over the 12 months. More zolpidem than placebo capsules were self-administered, and the total number of placebo or zolpidem capsules self-administered did not differ as a function of duration of use. In contrast, the total number of placebo capsules self-administered by the placebo group increased across time. The nightly capsule self-administration on zolpidem nights did not differ from that on placebo nights and neither nightly self-administration rates increased over the 12 months. An average 9.3 mg nightly dose was self-administered. CONCLUSIONS:Zolpidem was preferred to placebo, but its self-administration did not increase with 12 months of use. Chronic hypnotic use by primary insomniacs does not lead to dose escalation.
RCT Entities:
STUDY OBJECTIVES: To assess hypnotic self-administration and likelihood of dose escalation over 12 months of nightly use of zolpidem versus placebo in primary insomniacs. DESIGN: Randomized, double-blind, placebo-controlled, clinical trial. SETTING:Outpatient with tri-monthly one-week, sleep laboratory assessments. PARTICIPANTS: Thirty-three primary insomniacs, without psychiatric disorders or drug and alcohol abuse, 32-64 yrs old, 14 men and 19 women. INTERVENTIONS:Participants were randomized to take zolpidem 10 mg (n = 17) or placebo (n = 16) nightly for 12 months. In probes during month 1, 4, and 12, after sampling color-coded placebo or zolpidem capsules on 2 nights, color-coded zolpidem or placebo was chosen on 5 consecutive nights and 1, 2, or 3 of the chosen capsules (5 mg each) could be self-administered on a given choice night. RESULTS:Zolpidem was chosen more nights than placebo (80% of nights) and number of nights zolpidem was chosen did not differ over the 12 months. More zolpidem than placebo capsules were self-administered, and the total number of placebo or zolpidem capsules self-administered did not differ as a function of duration of use. In contrast, the total number of placebo capsules self-administered by the placebo group increased across time. The nightly capsule self-administration on zolpidem nights did not differ from that on placebo nights and neither nightly self-administration rates increased over the 12 months. An average 9.3 mg nightly dose was self-administered. CONCLUSIONS:Zolpidem was preferred to placebo, but its self-administration did not increase with 12 months of use. Chronic hypnotic use by primary insomniacs does not lead to dose escalation.
Authors: T Hori; Y Sugita; E Koga; S Shirakawa; K Inoue; S Uchida; H Kuwahara; M Kousaka; T Kobayashi; Y Tsuji; M Terashima; K Fukuda; N Fukuda Journal: Psychiatry Clin Neurosci Date: 2001-06 Impact factor: 5.188
Authors: James K Walsh; Andrew D Krystal; David A Amato; Robert Rubens; Judy Caron; Thomas C Wessel; Kendyl Schaefer; James Roach; Gene Wallenstein; Thomas Roth Journal: Sleep Date: 2007-08 Impact factor: 5.849
Authors: Ramona Shayegani; Kangwon Song; Megan E Amuan; Carlos A Jaramillo; Blessen C Eapen; Mary Jo Pugh Journal: PLoS One Date: 2018-01-23 Impact factor: 3.240