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

中文翻译：

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0494停止使用催眠药的能力：更新

摘要

介绍

开处方催眠药的医生仍然担心患者在长期使用后无法终止催眠药。从未在使用自我管理选择程序的对照前瞻性研究中直接检验过这种担忧。这是正在进行的“盲”临床试验结果的更新，在该试验中，失眠症患者应在每晚使用6个月后停止服用研究药物。

方法

DSM-V诊断为失眠受试者，年龄在23-61岁（n = 31，26位女性），睡眠受到干扰（即多导睡眠图睡眠效率≤85％），无其他睡眠障碍，不稳定的医学或精神病或药物依赖完成了审判。参与者随机接受唑吡坦XR（12.5 mg），依佐匹克隆（3 mg）或安慰剂每晚6个月（盲组A：n = 11，B：n = 9，C：n = 11）。每晚使用6个月后，在2周的选择期内，他们被指示停止催眠使用，但如有必要，应自行服用1、2或3胶囊指定药物（zolpidem XR 6.25 mg，6.25毫克，安慰剂；依索匹克隆2毫克，1毫克，安慰剂分别为胶囊1、2和3；或3个安慰剂。

结果

服用的胶囊数量从第1周减少到第2周（p <.001）。在两周内，共有15名参与者服用了0（48％），12≤6（39％）和4≥10个胶囊（每个分别服用了42、19、13和10个胶囊）。在服用胶囊的人中，大多数每晚服用1胶囊，而6服用> 1胶囊。≥10的4位患者年龄较小（p <.05），但在筛查睡眠效率或盲法治疗组方面无差异。重要的是，有一名受试者服用了所有可用胶囊。

结论

与会的大多数（87％）停产6个月的夜间催眠使用（即把≤总共6个胶囊）和服用胶囊率1周下降到2之间的年龄可能有助于发现难以中止数。

支持

NIDA，授予＃：R01DA038177授予Roehrs博士