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0463 Sleep Assessed by Actigraphy during Discontinuation of Chronic Hypnotic Use

Vartika Parashar, Gail Koshorek, Thomas Roth, Timothy Roehrs

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Abstract

Abstract Introduction Inability to discontinue chronic hypnotic use by people with insomnia remains a clinical problem. Sleep was recorded by actigraphy during a two-week discontinuation in an on-going “blinded” clinical trial in which people with insomnia were instructed to discontinue their study medication after 6 months of nightly use. Methods DSM-V diagnosed people with insomnia (n=39, 34 females), aged 26-61 yrs, with 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=15, B: n=11, C: n=13). 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). Sleep was recorded by actigraphy and sleep latency (LAT), wake after sleep onset (WASO), and sleep efficiency (SE) were determined. Results Twenty subjects (51%) stopped taking study medication when told to discontinue, while 19 took a median of 3 capsules over the 14 nights. The number of capsules chosen declined from week 1 to week 2 (p<.005), while WASO (7-night means) increased from week 1 to week 2 (p<.02). However, LAT, WASO, and SE never went beyond the 7-night means recorded at baseline. Discontinuation night 1 and 2 also did not differ from baseline nights 1 and 2. Conclusion Most participants successfully discontinued hypnotic use when instructed to do so. While some degree of sleep disturbance returned, it never exceeded the baseline levels. Support (If Any) NIDA, grant#: R01DA038177 awarded to Dr. Roehrs.

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Abstract Introduction Inability to discontinue chronic hypnotic use by people with insomnia remains a clinical problem. Sleep was recorded by actigraphy during a two-week discontinuation in an on-going “blinded” clinical trial in which people with insomnia were instructed to discontinue their study medication after 6 months of nightly use. Methods DSM-V diagnosed people with insomnia (n=39, 34 females), aged 26-61 yrs, with 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=15, B: n=11, C: n=13). 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). Sleep was recorded by actigraphy and sleep latency (LAT), wake after sleep onset (WASO), and sleep efficiency (SE) were determined. Results Twenty subjects (51%) stopped taking study medication when told to discontinue, while 19 took a median of 3 capsules over the 14 nights. The number of capsules chosen declined from week 1 to week 2 (p<.005), while WASO (7-night means) increased from week 1 to week 2 (p<.02). However, LAT, WASO, and SE never went beyond the 7-night means recorded at baseline. Discontinuation night 1 and 2 also did not differ from baseline nights 1 and 2. Conclusion Most participants successfully discontinued hypnotic use when instructed to do so. While some degree of sleep disturbance returned, it never exceeded the baseline levels. Support (If Any) NIDA, grant#: R01DA038177 awarded to Dr. Roehrs.

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Abstract Introduction Inability to discontinue chronic hypnotic use by people with insomnia remains a clinical problem. Sleep was recorded by actigraphy during a two-week discontinuation in an on-going “blinded” clinical trial in which people with insomnia were instructed to discontinue their study medication after 6 months of nightly use. Methods DSM-V diagnosed people with insomnia (n=39, 34 females), aged 26-61 yrs, with 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=15, B: n=11, C: n=13). 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). Sleep was recorded by actigraphy and sleep latency (LAT), wake after sleep onset (WASO), and sleep efficiency (SE) were determined. Results Twenty subjects (51%) stopped taking study medication when told to discontinue, while 19 took a median of 3 capsules over the 14 nights. The number of capsules chosen declined from week 1 to week 2 (p<.005), while WASO (7-night means) increased from week 1 to week 2 (p<.02). However, LAT, WASO, and SE never went beyond the 7-night means recorded at baseline. Discontinuation night 1 and 2 also did not differ from baseline nights 1 and 2. Conclusion Most participants successfully discontinued hypnotic use when instructed to do so. While some degree of sleep disturbance returned, it never exceeded the baseline levels. Support (If Any) NIDA, grant#: R01DA038177 awarded to Dr. Roehrs.

Key concepts: Actigraphy, Discontinuation, Sleep onset, Insomnia, Sleep onset latency, Placebo, Sleep diary, Hypnotic

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