Search

ObjectiveThe authors sought to determine whether targeted treatment of insomnia with controlled-release zolpidem (zolpidem-CR) in suicidal adults with insomnia would provide a reduction in suicidal ideation superior to placebo.MethodsReducing Suicidal Ideation Through Insomnia Treatment was an 8-week three-site double-blind placebo-controlled parallel-group randomized controlled trial of zolpidem-CR hypnotic therapy compared with placebo, in conjunction with an open-label selective serotonin reuptake inhibitor. Participants were medication-free 18- to 65-year-olds with major depressive disorder, insomnia, and suicidal ideation. Suicidal ideation was the main outcome, measured first by the Scale for Suicide Ideation and second by the Columbia-Suicide Severity Rating Scale (C-SSRS).ResultsA total of 103 participants were randomly assigned to receive zolpidem-CR (N=51) or placebo (N=52) (64 women and 39 men; mean age=40.5 years). Zolpidem-CR had a robust anti-insomnia effect, especially in patients with the most severe insomnia symptoms. No significant treatment effect was observed on the Scale for Suicide Ideation (least squares mean estimate=-0.56, SE=0.83, 95% CI=-2.19, 1.08), but the reduction in scores was significantly positively related to improvement in insomnia after accounting for the effect of other depression symptoms. The C-SSRS indicated that zolpidem-CR had a significant treatment effect (least squares mean estimate=-0.26, SE=0.12, 95% CI=-0.50, -0.02). The advantage for zolpidem-CR in reducing suicidal ideation on the C-SSRS was greater in patients with more severe insomnia. No deaths or suicide attempts occurred.ConclusionsAlthough the results do not support the routine prescription of hypnotic medication for mitigating suicidal ideation in all depressed outpatients with insomnia, they suggest that coprescription of a hypnotic during initiation of an antidepressant may be beneficial in suicidal outpatients, especially in patients with severe insomnia.

In this paper, we report the rate of previously undiagnosed obstructive sleep apnea (OSA) in a randomized clinical trial (RCT) of suicidal patients with major depressive disorder (MDD). One hundred and twenty-five suicidal adults with MDD were recruited into a RCT. None were suspected to have OSA. Fourteen percent met diagnostic criteria for OSA. The Apnea Hypopnea Index (AHI) was predicted by increasing age, male sex, and higher Body Mass Index. However, neither the degree of daytime sleepiness nor the degree of insomnia predicted AHI severity. A high degree of suspicion is warranted for OSA in suicidal patients with MDD, and for patients with treatment-resistant depression. ClinicalTrials.gov identifier: NCT01689909.

BackgroundEpidemiological data have demonstrated seasonal and circadian patterns of suicidal deaths. Several reviews and meta-analyses have confirmed the relationship between sleep disturbance and suicidality. However, these reviews/meta-analyses have not focused on seasonal and circadian dysfunction in relation to suicidality, despite the common presence of this dysfunction in patients with mood disorders. Thus, the current literature review analyzed studies investigating person-specific chronotype, seasonality, and rhythmicity in relation to suicidal thoughts and behaviors.MethodsStudy authors reviewed articles related to individual-level chronotype, seasonality, and rhythmicity and suicidality that were written in English and not case reports or reviews.ResultsThis review supports a relationship between an eveningness chronotype, greater seasonality, and decreased rhythmicity with suicidal thoughts and behaviors in those with unipolar depression, as well as in other psychiatric disorders and in children/adolescents.LimitationsThese findings need to be explored more fully in mood disordered populations and other psychiatric populations, in both adults and children, with objective measurement such as actigraphy, and with chronotype, seasonality, and rhythmicity as well as broader sleep disturbance measurement all included so the construct(s) most strongly linked to suicidality can be best identified.ConclusionsEveningness, greater seasonality, and less rhythmicity should be considered in individuals who may be at risk for suicidal thoughts and behaviors and may be helpful in further tailoring assessment and treatment to improve patient outcome.

ObjectiveInsomnia is associated with increased risk for suicide. The Food and Drug Administration (FDA) has mandated that warnings regarding suicide be included in the prescribing information for hypnotic medications. The authors conducted a review of the evidence for and against the claim that hypnotics increase the risk of suicide.MethodThis review focused on modern, FDA-approved hypnotics, beginning with the introduction of benzodiazepines, limiting its findings to adults. PubMed and Web of Science were searched, crossing the terms "suicide" and "suicidal" with each of the modern FDA-approved hypnotics. The FDA web site was searched for postmarketing safety reviews, and the FDA was contacted with requests to provide detailed case reports for hypnotic-related suicide deaths reported through its Adverse Event Reporting System.ResultsEpidemiological studies show that hypnotics are associated with an increased risk for suicide. However, none of these studies adequately controlled for depression or other psychiatric disorders that may be linked with insomnia. Suicide deaths have been reported from single-agent hypnotic overdoses. A separate concern is that benzodiazepine receptor agonist hypnotics can cause parasomnias, which in rare cases may lead to suicidal ideation or suicidal behavior in persons who were not known to be suicidal. On the other hand, ongoing research is testing whether treatment of insomnia may reduce suicidality in adults with depression.ConclusionsThe review findings indicate that hypnotic medications are associated with suicidal ideation. Future studies should be designed to assess whether increases in suicidality result from CNS impairments from a given hypnotic medication or whether such medication decreases suicidality because of improvements in insomnia.

Background/aimsSuicide is a major public health concern, yet there are very few randomized clinical trials that have been conducted to reduce suicidal ideation in patients at risk of suicide. We describe the rationale and refinements of such a trial that is designed to assess the effect of a hypnotic medication on suicidal ideation in adult outpatients currently experiencing suicidal ideation.Methods"Reducing Suicidal Ideation Through Insomnia Treatment" is a multi-site randomized clinical trial that includes three recruiting sites and one data management site. This 4-year study is in its second year of recruitment. The purpose of the study is to compare hypnotic medication versus placebo as an add-on treatment to a selective serotonin reuptake inhibitor as a means of reducing suicidal ideation in depressed adult outpatients with insomnia and suicidal ideation. The safety features of the study follow the 2001 National Institutes of Health guidelines for studies that include patients at risk of suicide.ResultsIn total, 584 potential participants have undergone telephone screening; 67% of these failed the phone screen, most often due to an absence of expressed suicidal ideation (26% of the telephone screen fails). A total of 115 people appeared for a face-to-face baseline assessment, and 40 of these had completed a taper off of their ineffective psychotropic medications before the baseline assessments. In all, 64% of those who completed baseline assessments failed to proceed to randomization, most commonly because of no clinically significant suicidal ideation (51% of those excluded at baseline). One participant was offered and accepted voluntary psychiatric hospitalization in lieu of study participation. Thus far, 40 participants have been randomized into the study and 88.7% of scheduled visits have been attended, with 93.8% adherence to the selective serotonin reuptake inhibitor and 91.6% adherence to the randomized hypnotic versus placebo. None of the randomized participants have required hospitalization or had a suicide attempt.ConclusionBy carefully considering the inclusion and exclusion criteria and other safety features, the safe conduct of randomized clinical trials in suicidal adult patients is possible, including the inclusion of participants who have undergone a prescribed tapering off of psychotropic medications prior to baseline assessment.

Weight gain is a common side effect of adjuvant chemotherapy for breast cancer. Some patient groups gain more than others; for example, 25% of premenopausal patients will gain >11 kg over the course of treatment. Previous studies suggest that this weight gain may decrease both disease-free and over-all survival and decrease quality of life. This weight gain also is distinct, because patients lose lean body mass as their weight increases. We explored whether a clinic-based exercise program that promoted aerobic exercise and a specialized program of strength training and dietary change ([less than or equal to] 20% fat; fruit, vegetable and calcium-rich diet) could prevent body composition change in Stage I/II premenopausal breast cancer patients who would receive adjuvant chemotherapy. Dual-energy X-ray absorptiometry was used to assess body composition at baseline and 6 mo. Mean change (SE) for historic patient controls (n = 36) and intervention participants (n = 9), respectively, are as follows: body weight, +2.2 (0.4) and -2.1 (1.3) kg; lean mass, -0.3 (