Anderson, 2014 Quetiapine for insomnia: A review of the literature.

[Altostrata]

Quite often, the most objective studies of drug adverse effects come from pharmacists.

 

Am J Health Syst Pharm. 2014 Mar 1;71(5):394-402. doi: 10.2146/ajhp130221.
Quetiapine for insomnia: A review of the literature.
Anderson SL¹, Vande Griend JP.

Abstract at http://www.ncbi.nlm.nih.gov/pubmed/24534594

PURPOSE:
The safety and efficacy of quetiapine for the treatment of insomnia in adults are reviewed.

SUMMARY:
Quetiapine was developed for the treatment of psychiatric disorders, but its antagonism of histamine H1- and serotonin type 2A receptors has the added effect of causing sedation. As such, quetiapine is widely used off-label as a treatment for insomnia. Due to quetiapine's potential adverse effects, guidelines for the treatment of insomnia have recommended the drug's use only in patients with specific comorbid psychiatric disorders. The use of quetiapine for the treatment of insomnia in the absence of comorbid conditions has been evaluated in only two clinical trials of 31 patients in total, and very few studies have evaluated quetiapine use in patients with insomnia and other comorbidities. No trials have been conducted comparing quetiapine with an active control (e.g., zolpidem); the data that exist compare quetiapine to a placebo or there is no comparison and all patients are treated with quetiapine. Very few studies have evaluated quetiapine's efficacy in the treatment of insomnia using sleep objective testing, another limitation of the available data on quetiapine.

CONCLUSION:
Robust studies evaluating the safety and efficacy of quetiapine for the treatment of insomnia are lacking. Given its limited efficacy data, its adverse-effect profile, and the availability of agents approved by the Food and Drug Administration for the treatment of insomnia, quetiapine's benefit in the treatment of insomnia has not been proven to outweigh potential risks, even in patients with a comorbid labeled indication for quetiapine.

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Ann Pharmacother. 2012 May;46(5):718-22. doi: 10.1345/aph.1Q697. Epub 2012 Apr 17.
Safety of low doses of quetiapine when used for insomnia.
Coe HV¹, Hong IS.

Abstract at http://www.ncbi.nlm.nih.gov/pubmed/22510671

OBJECTIVE:
To evaluate the safety of low doses of quetiapine when used for insomnia.

DATA SOURCES:
A literature search was performed using PubMed and EMBASE (January 1990-November 2011) using the terms quetiapine, insomnia, sleep, low-dose, subtherapeutic, safety, and weight gain.

STUDY SELECTION AND DATA EXTRACTION:
Two prospective trials were identified that evaluated the effect of quetiapine in primary insomnia. In addition, 2 retrospective cohort studies were identified that evaluated the safety of low doses of quetiapine when used for insomnia. Several case reports on adverse effects with low doses of the drug were also included.

DATA SYNTHESIS:
Quetiapine is commonly used off-label for treatment of insomnia. When used for sleep, doses typically seen are less than the Food and Drug Administration-recommended dosage of 150-800 mg/day; those evaluated in the studies reviewed here were 25-200 mg/day). At recommended doses, atypical antipsychotics such as quetiapine are associated with metabolic adverse events (diabetes, obesity, hyperlipidemia). Adverse effects in the prospective trials were patient-reported and were minor, including drowsiness and dry mouth; however, the trials were limited by their small sample size and short duration. The retrospective cohort studies found that quetiapine was associated with significant increases in weight compared to baseline. Serious adverse events identified from case reports included fatal hepatotoxicity, restless legs syndrome, akathisia, and weight gain.

CONCLUSIONS:
There are potential safety concerns when using low-dose quetiapine for treatment of insomnia. These concerns should be evaluated in further prospective studies. Based on limited data and potential safety concerns, use of low-dose quetiapine for insomnia is not recommended.