Greater incidence of depression with hypnotic use than with placebo

Kripke, Daniel F.
January 2007
BMC Psychiatry;2007, Vol. 7, p42
Academic Journal
Background: Although it has been claimed that insomnia causes an increased risk for depression, adequate controlled trials testing this hypothesis have not been available. This study contrasted the incidence of depression among subjects receiving hypnotics in randomized controlled trials versus those receiving placebo. Methods: The incidence of depression among patients randomized to hypnotic drugs or placebo was compiled from prescribing information approved by the United States Food and Drug Administration (FDA) and from FDA New Drug Application documents. Available data for zolpidem, zaleplon, eszopiclone, and ramelteon were accessed. Results: Data for 5535 patients randomized to a hypnotic and for 2318 randomized to placebo were compiled. The incidence of depression was 2.0% among participants randomized to hypnotics as compared to 0.9% among those randomized in parallel to placebo (p < 0.002). Conclusion: Modern hypnotics were associated with an increased incidence of depression in data released by the FDA. This suggests that when there is a risk of depression, hypnotics may be contra-indicated. Preventive treatments such as antidepressant drugs, cognitive-behavioral therapy, or bright light might be preferred. Limitations in the FDA data prevented a formal meta-analysis, and there was a lack of information about drop-out rates and definitions of depression. Trials specifically designed to detect incident depression when treating insomnia with hypnotic drugs and better summarization of adverse events in trials submitted to the FDA are both necessary.


Related Articles

  • FDA APPROVES ILOPERIDONE FOR THE TREATMENT OF SCHIZOPHRENIA. Naccari, Christopher // Primary Psychiatry;Jun2009, Vol. 16 Issue 6, p12 

    The article reports on the approval of iloperidone for the treatment of schizophrenia in adults by the U.S. Food and Drug Administration (FDA). The results of two short-term, placebo-controlled clinical trials were used by FDA as the basis of the approval. Dizziness, dry mouth and fatigue were...

  • Fesoterodine in randomised clinical trials: an updated systematic clinical review of efficacy and safety. Dell'Utri, Chiara; Digesu, G.; Bhide, Alka; Khullar, Vik // International Urogynecology Journal;Oct2012, Vol. 23 Issue 10, p1337 

    Introduction and hypothesis: This is a systematic review of clinical data assessing the safety, efficacy and tolerability of fesoterodine in randomised control trials (RCTs) in the treatment of overactive bladder (OAB). Methods: We performed a MEDLINE literature search of articles published...

  • US FDA reviewing safety of ezetimibe/simvastatin.  // Reactions Weekly;8/30/2008, Issue 1217, p2 

    The article reports on the safety review by the U.S. Food and Drug Administration (FDA) of ezetimibe (Vytorin) and simvastatin after receiving a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial about a possible association between ezetimibe use and increased cancer risk....

  • FDA Approves Cimzia for Crohn's Disease.  // Bioworld Week;4/28/2008, Vol. 16 Issue 17, p4 

    The article reports on the approval of UCB SA's Cimzia (certolizumab pegol), a PEGylated antitumor- necrosis-factor (TNF)-alpha antibody by the Food & Drug Administration (FDA) for Crohn's disease. It states that datum from Phase III pivotal studies presented patients with moderate to severe...

  • Abilify Approved for Acute Bipolar Mania. Stanwood, Karen G. // Journal of Psychosocial Nursing & Mental Health Services;Dec2004, Vol. 42 Issue 12, p32 

    The article reports on the approval of Abilify for the treatment of acute bipolar mania by the U.S. Food and Drug Administration. the approval was based on positive results from two placebo-controlled, 3-week trials of 516 hospitalized patients with bipolar I disorder. The drug's common side...

  • FDA advisers wary of expanding quetiapine use. Traynor, Kate // American Journal of Health-System Pharmacy;5/15/2009, Vol. 66 Issue 10, p880 

    The article discusses the concern of the U.S. Food and Drugs Administration (FDA) advisers on the expanded use of quetiapine fumarate. It mentions that advisers have agreed that it should not be used as a first line monotherapy for major depressive disorder (MDD) since its long term risk has not...

  • Questions still linger about Accutane, depression. Gillete, Bill // Dermatology Times;Jan2005, Vol. 26 Issue 1, p15 

    The article reports that questions continue to linger about Accutane and its possible link to depression, even as the U.S. Food and Drug Administration prepares to tighten monitoring of the controversial acne drug and its generic equivalents. The drug can caused severe birth defects and has been...

  • Smoking Cessation and Psychiatric Effects.  // Infectious Disease Alert;Sep2009 Pharmacology Watch, p2 

    The article offers advice from the U.S. Food and Drug Administration (FDA) regarding smoking cessation drugs varenicline (Chantix) and bupropion (Zyban, Wellbutrin) and their side effects. The FDA required a new box warnings emphasizing the risk of serious neuropsychiatric symptoms associated...

  • FDA APPROVES DULOXETINE FOR MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER. Lanche, Michelisa // CNS Spectrums: The International Journal of Neuropsychiatric Med;Jan2008, Vol. 13 Issue 1, p23 

    The article reports that the U.S. Food and Drug Administration has approved duloxetine for the maintenance treatment of major depressive disorder (MDD) in adults of, or above 18 years of age. It reports that during the acute phase, the most frequently reported side effect was, nausea. Duloxetine...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics