title: Twelve months of nightly zolpidem does not lead to dose escalation: a prospective placebo-controlled study.
abstract: OBJECTIVE
  To assess hypnotic self-administration and likelihood of dose escalation over 12 months of nightly use of zolpidem versus placebo in primary insomniacs.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled, clinical trial.
  
  
  METHODS
  Outpatient with tri-monthly one-week, sleep laboratory assessments.
  
  
  METHODS
  Thirty-three primary insomniacs, without psychiatric disorders or drug and alcohol abuse, 32-64 yrs old, 14 men and 19 women.
  
  
  METHODS
  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.affiliation: Sleep Disorders and Research Center, Henry Ford Hospital, 2799 W. Grand Blvd., Detroit, MI 48202, USA. troehrs1@hfhs.org
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Roehrs
authors.forename: Surilla
authors.initials: S
authors.lastname: Randall
authors.forename: Erica
authors.initials: E
authors.lastname: Harris
authors.forename: Renee
authors.initials: R
authors.lastname: Maan
authors.forename: Thomas
authors.initials: T
authors.lastname: Roth
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000627:therapeutic use*; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011446:Prospective Studies; D011725:Pyridines / Q000008:administration & dosage / Q000627:therapeutic use*; D012646:Self Administration; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D000077334:Zolpidem
chemical_list: D006993:Hypnotics and Sedatives; D011725:Pyridines; D000077334:Zolpidem