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Concept: Zopiclone

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To compare the efficacy of telephone-delivered cognitive-behavioral therapy for insomnia to an information pamphlet control on sleep and daytime functioning at pretreatment, posttreatment, and 12-wk follow-up.

Concepts: Randomized controlled trial, Clinical psychology, Cognitive behavioral therapy, Psychotherapy, Generalized anxiety disorder, Behaviour therapy, Zopiclone

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STUDY OBJECTIVES: To evaluate efficacy and safety of 3.5-mg zolpidem tartrate sublingual tablets (ZST) on latency to sleep onset after middle-of-the-night (MOTN) awakenings in patients with insomnia characterized by difficulty returning to sleep after MOTN awakenings. DESIGN: Multicenter randomized, double-blind, placebo-controlled, parallel-group. SETTING: Outpatient. PATIENTS: There were 295 adults (median age 43 y; 68.1% female) with primary insomnia and difficulty returning to sleep after MOTN awakenings (three or more MOTN awakenings/wk during screening). INTERVENTIONS: After a 2-wk, single-blind placebo eligibility period, participants were randomized 1:1 to as-needed MOTN dosing with 3.5 mg ZST or placebo for 28 nights. An interactive voice response system determined if the study drug could be taken and recorded sleep/wake efficacy measures. RESULTS: ZST significantly (P < 0.0001) decreased latency to sleep onset over 4 wk (baseline 68.1 min; ZST 38.2 min) compared with placebo (baseline 69.4 min; placebo 56.4 min). Ratings of morning sleepiness/alertness significantly (P = 0.0041) favored the ZST group on nights medication was taken but not on other nights. Participants in the ZST group took the study drug on 62% of nights during the 4 wk; members of the placebo group took study medication on 64% of nights. Adverse events were generally mild and at the same rate (19.3% of participants) in both groups. There were no treatment-related serious adverse events (SAEs), and one adverse event-related study discontinuation from the placebo group. Dosing/week did not increase across the study. CONCLUSIONS: 3.5 mg ZST used as needed significantly reduced latency to return to sleep in comparison with placebo in these patients with insomnia. Sleep quality was improved, and morning sleepiness/alertness scores also improved. ZST was well tolerated. These data demonstrate the utility of a sleep-promoting agent when used as needed in the MOTN. CLINICAL TRIAL INFORMATION: CLINICAL TRIALS REGISTRATION: NCT00466193: "A Study of Zolpidem Tartrate Tablet in Adult Patients with Insomnia" http://www.clinicaltrials.gov/ct2/show/NCT00466193?spons=%22Transcept+Pharmaceuticals%22&spons_ex=Y&rank=2 CITATION: Roth T; Krystal A; Steinberg FJ; Singh NN; Moline M. Novel sublingual low-dose zolpidem tablet reduces latency to sleep onset following spontaneous middle-of-the-night awakening in insomnia in a randomized, double-blind, placebo-controlled, outpatient study. SLEEP 2013;36(2):189-196.

Concepts: Clinical trial, Placebo, Benzodiazepine, Hypnotic, Insomnia, Zolpidem, Zopiclone, Nonbenzodiazepine

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To test cognitive-behavioral therapy for insomnia (CBT-I) in patients who not only receive psychiatric treatment in a outpatient psychiatry clinic but also continue to experience chronic insomnia despite receiving pharmacological treatment for sleep. CBT-I included an optional module for discontinuing hypnotic medications.

Concepts: Medicine, Sleep medicine, Mental disorder, Clinical psychology, Psychotherapy, Generalized anxiety disorder, Hypnotic, Zopiclone

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Alexithymia is characterized by difficulty identifying feelings, difficulty describing feelings, and an externally oriented thinking style. Alexithymia has been described as a trait-like risk factor for the development of alcohol use disorders. Few studies have investigated the absolute (whether mean scores change over time) and relative (extent to which relative differences among individuals remain the same over time) stability of alexithymia among men and women with alcohol dependence, or have considered potential underlying mechanisms. Social learning processes contribute to and maintain alcohol problems. The reinforcement of alcohol expectancies is one plausible mechanism that links the difficulties in emotional processing associated with alexithymia and alcohol use. The present study investigated the stability of alexithymia as well as alcohol expectancy as a mediator of alexithymia. Three hundred fifty-five alcohol-dependent patients were enrolled in a cognitive behavioral treatment program. Ninety-two alcohol-dependent patients completed assessments at baseline and at 3-month follow-up. Results indicated that total Toronto Alexithymia Scale (TAS-20; Bagby, Parker, & Taylor, 1994) mean score, difficulty identifying feelings, and difficulty describing feelings decreased significantly over time with a larger decrease in alexithymia mean scores for females. Externally oriented thinking mean scores did not change. The TAS-20 and its subfactors demonstrated significant correlations, from baseline to follow-up, which were stronger for males than for females. Regression analyses showed that the total TAS-20 mean scores, difficulty identifying feelings, and difficulty describing feelings were partially mediated through assertion alcohol expectancies. In conclusion, this suggests that alexithymia has relative stability and is a trait-like factor among alcohol-dependent treatment seekers. (PsycINFO Database Record

Concepts: Psychology, Alcoholism, Cognition, Alcohol abuse, Cognitive behavioral therapy, Drinking culture, Zopiclone, Alexithymia

17

Because psychological approaches are likely to produce sustained benefits without the risk for tolerance or adverse effects associated with pharmacologic approaches, cognitive behavioral therapy for insomnia (CBT-i) is now commonly recommended as first-line treatment for chronic insomnia.

Concepts: Psychology, Medicine, Educational psychology, Adverse drug reaction, Psychotherapy, Generalized anxiety disorder, Behaviorism, Zopiclone

14

Chronic insomnia is a major public health problem affecting approximately 10% of adults. Use of meditation and yoga to develop mindful awareness (‘mindfulness training’) may be an effective approach to treat chronic insomnia, with sleep outcomes comparable to nightly use of prescription sedatives, but more durable and with minimal or no side effects. The purpose of this study was to understand mindfulness training as experienced by patients with chronic insomnia, and suggest procedures that may be useful in optimizing sleep benefits.

Concepts: Effect, Sleep, Benzodiazepine, Meditation, Hypnotic, Zopiclone, Nonbenzodiazepine, Mind-body interventions

8

Cognitive behavioral therapy for insomnia (CBT-I) is the most prominent nonpharmacologic treatment for insomnia disorders. Although meta-analyses have examined primary insomnia, less is known about the comparative efficacy of CBT-I on comorbid insomnia.

Concepts: Psychology, Medicine, Systematic review, Mental disorder, Psychiatry, Psychotherapy, Insomnia, Zopiclone

6

Long-term sedative use is prevalent and associated with significant morbidity, including adverse events such as falls, cognitive impairment, and sedation. The development of dependence can pose significant challenges when discontinuation is attempted as withdrawal symptoms often develop. We conducted a scoping review to map and characterize the literature and determine opportunities for future research regarding deprescribing strategies for long-term benzodiazepine and Z-drug (zopiclone, zolpidem, and zaleplon) use in community-dwelling adults.

Concepts: Physical dependence, Withdrawal, Benzodiazepine, Hypnotic, Zaleplon, Zolpidem, Zopiclone, Nonbenzodiazepine

4

zolpidem, zopiclone, eszopiclone and zaleplon, also known as ‘Z-drugs’, are commonly used as alternatives to benzodiazepines (BZDs) to treat insomnia. Z-drugs are often perceived as safer than BZDs. We conducted a systematic review and meta-analysis evaluating the association between Z-drugs and fracutres, falls and injuries.

Concepts: Benzodiazepine, Hypnotic, Insomnia, Zaleplon, Zolpidem, Zopiclone, Nonbenzodiazepine, Z-drug

4

While impairment of daytime functioning due to poor sleep is often the main determinant for seeking treatment, few studies have examined the clinical impact of insomnia therapies on daytime outcomes. The main objective of this study was to evaluate the impact of cognitive-behavior therapy (CBT), alone and combined with medication, on various indices of daytime and psychological functioning. Participants were 160 individuals with chronic insomnia who received CBT alone or CBT plus medication (zolpidem) for an initial six-week therapy, followed by an extended six-month therapy. Participants treated with CBT initially received maintenance CBT or no additional treatment and those treated with combined therapy initially continued with CBT plus intermittent medication (prn) or CBT without medication (taper). Measures of anxiety and depressive symptoms, fatigue, quality of life, and perceived impact of sleep difficulties on various indices of daytime functioning were completed at baseline, after each treatment stage, and at six-month follow-up. Following acute treatment, significant improvements of fatigue, quality of life (mental component), anxiety, and depression were obtained in the CBT alone condition but not in the combined CBT plus medication condition. Following extended treatment, further improvements were noted for the subgroup receiving extended CBT relative to that with no additional treatment, and for the subgroup receiving CBT and intermittent medication relative to that with CBT but no medication. Improvements were well maintained at the 6-month follow-up. These findings indicate that insomnia-specific therapy is effective at improving daytime and psychological functioning in the short term, and that maintenance therapy produces an added value to optimize long-term outcomes.

Concepts: Psychology, Sleep deprivation, Cognitive behavioral therapy, Term, Hypnotic, Insomnia, Zopiclone, Nonbenzodiazepine