Abstract
Introduction
Rebound insomnia refers to worsened sleep relative to baseline on 1-2 nights after discontinuation of active hypnotic medication. Rebound is typically assessed using a placebo substitution. We assessed rebound in an on-going “blinded” clinical trial in which people with insomnia are instructed to discontinue their study medication (i.e., no-pill) after 6 months of nightly use.
Methods
DSM-V diagnosed people with insomnia (n=31, 26 females), aged 26-61 yrs, with a polysomnographic sleep efficiency of ≤85%, no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the clinical trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg) or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, over a 2-week choice period, they were given the instruction to discontinue their nightly hypnotic use with an opportunity, if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos). On baseline and the14 discontinuation nights, sleep was recorded and scored by actigraphy for sleep efficiency (SE), sleep latency (LAT) and wake after sleep onset (WASO).
Results
Relative to the baseline night, on the first discontinuation night there was no difference in SE, LAT, and WASO. Fifteen subjects stopped taking study medication when told to discontinue and 16 subjects took study medication on one night or more. While not differing on baseline or night 1, on night 14 the last study night the medication users had a lower SE (75.9 vs 87.7 %, p<.0.004) and a longer LAT (61.5 vs 14.5 min, p<0.05).
Conclusion
Difficulty discontinuing hypnotic use is not specifically related to rebound insomnia. We reported in a companion abstract those with insomnia and hyperarousal, defined by MSLT, are those with difficulty discontinuing hypnotic use and as shown here slept poorly on the last study night.
Support
NIDA, grant#: R01DA038177 awarded to Dr. Roehrs
Droperidol dropped; consultants not consulted
