Abstract
Introduction
Physicians prescribing hypnotics remain concerned regarding patient’s inability to discontinue hypnotics after chronic use. That concern has never been directly tested in a controlled prospective study using self-administration choice procedures. This is an update on results from an on-going “blinded” clinical trial in which insomnia subjects are instructed to stop taking their study medication after 6 months of nightly use.
Methods
DSM-V diagnosed insomnia subjects, aged 23-61 yrs, (n=31, 26 females), with disturbed sleep (i.e., polysomnographic sleep efficiency of ≤85%), no other sleep disorder, unstable medical or psychiatric diseases or drug dependency completed the 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, nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but 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).
Results
The number of capsules taken declined from week 1 to 2 (p< .001). Over the 2 weeks 15 participants took 0 (48%), 12 ≤ 6 (39%) and 4 ≥10 total capsules (1 each took 42, 19, 13, and 10). Among those taking capsules, most took one capsule per night and 6 took > 1 capsule. Those 4 taking ≥ 10 were younger (p<.05), but did not differ in screening sleep efficiency or blinded treatment group. Importantly 1 subject took every capsule available.
Conclusion
The majority (87%) of the participants discontinued 6-month nightly hypnotic use (i.e. took ≤ 6 total capsules) and among those taking capsules the rate declined from week 1 to 2. Age may help identify the few with difficulty discontinuing.
Support
NIDA, grant#: R01DA038177 awarded to Dr. Roehrs