Mood and Difficulty Discontinuing Chronic Hypnotic Use

Document Type

Conference Proceeding

Publication Date

2-1-2025

Publication Title

Drug Alcohol Depend

Keywords

benzodiazepine derivative, eszopiclone, hypnotic agent, placebo, sedative agent, zolpidem, adverse drug reaction, Beck Depression Inventory, clinical trial, conference abstract, controlled study, depression, drug dependence, drug self administration, drug therapy, DSM-5, Epworth sleepiness scale, female, human, insomnia, male, mental disease, mood, prospective study, randomized controlled trial, sham procedure, side effect, sleep disorder

Abstract

Drug Category: Benzodiazepines/Sedatives Topic: Behavioral Pharmacology Abstract Detail: Clinical - Experimental Abstract Category: Original Research Aim: The inability to discontinue hypnotics after chronic use remains a concern, which has never been directly tested in a controlled, blinded, prospective study using self-administration choice procedures. This study reports on measures of mood and difficulty discontinuing hypnotic use in a clinical trial in which persons with insomnia were instructed to stop taking their study medication after 6 months of nightly use. Methods: DSM-V diagnosed insomnia participants, aged 23-61 years, (n=41, 36 females), with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the trial. Following a screening NPSG participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg), or placebo nightly for 6 months. After 6 months nightly use, over a 2-week discontinuation, they were instructed to discontinue their hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules, each packaged separately in labeled envelopes, of their assigned “blinded” 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). The BDI II. BAI, ISI, ESS, and POMS were completed at study entry, month6, and study end. Results: Over the 14 nights 21 participants took zero (51%) capsules and among the 20 taking capsules (SAer) the median total number chosen was 3. BDI II scores at study entry were significantly higher (6.3 +/-2.4) in the SAer group compared to the non-SAer (3.2 +/- 0.8) group (p<0.05). SA groups did not differ in BAI, ISI, or ESS scores. At study end both BDI II (p<0.001) and BAI (p<0.05) scores had declined significantly from study entry levels. Conclusions: The majority (51%) of the participants discontinued 6-months of nightly hypnotic use. Higher depression scores (BDI II) were predictive of difficulty discontinuing chronic hypnotic use. Financial Support: NIDA, grant#: R01DA038177 awarded to Dr. Roehrs.

Volume

267

Share

COinS