Summary of studies assessing the effects of quetiapine (QTP) on sleep

StudyAgeDiagnosisDesign + Number of ParticipantsResultsAdverse EventsConclusion
Anderson and Vande Griend (2014)VariedVariedReview of the literature of quetiapine in the treatment of insomnia.VariedGiven QTP's adverse effects profile (see RCTs above), QTP's benefits have not been proven to outweigh the risk.Robust studies evaluating quetiapine for insomnia are lacking.
Baune et al. (2007)Males: mean 48.6, S.D. 12.9; Females: mean 50.5, S.D. 13.2Treatment-resistant unipolar or bipolar II depression4-wk open-label in-patient trial of QTP augmentation of venlafaxine or escitalopram. Mean QTP dose 340 mg/day, max 800 mg/day. N = 27.PSQI total score was 8.8 ± 2.8 at baseline and 5.2 ± 1.8 at week 4, P = 0.00. PSQI daytime sleepiness was 1.9 ± 0.8 at baseline and 0.8 ± 0.7 at week 4, P = 0.00.During the 4-wk study, neither adverse metabolic or clinical events nor significant weight gain were recorded.QTP is effective at reducing symptoms of insomnia in patients with depression.
Calabrese et al. (2005)18–65Type I or Type II bipolar depression8-wk RCT. QTP 300 vs. 600 mg/day vs. placebo. N = 542.Sleep difficulties were moderate to severe at baseline. PSQI total score at last assessment improved by 5.16 points with QTP 300 mg/day and 5.46 points with QTP 600 mg/day, compared with 2.94 points for placebo, P < 0.001 for both dosages relative to placebo.QTP 600 mg/day experienced 1.6 kg of weight gain vs. 1.0 kg in the 300 mg/day group and 0.2 kg in the placebo group. Mean change in fasting glucose was 6 ± 17 mg/dl in QTP 600 mg/day, 3 ± 13 mg/dl in QTP 300 mg/day, and 4 ± 26 mg/dl in the placebo group.QTP is effective at reducing symptoms of insomnia in bipolar depression.
Cohrs et al. (2004)19–33Healthy subjectsNine-night RCT. Three study periods lasting 3 days, with a 4 day washout. QTP 25 mg/day vs. QTP 100 mg/day vs. placebo. N = 14.Both doses QTP significantly improved LOS and sleep continuity under standard and acoustic stress conditions. Total sleep time and SE increased.Significant increase in periodic leg movements was observed with QTP 100 mg/day.QTP increases sleep in healthy volunteers.
Garakani et al. (2008)18–65Major depressive disorder8-wk RCT. QTP 25–100 mg/day + fluoxetine 20–40 mg/day vs. placebo + fluoxetine. N = 114.Mixed-effect regression models show that QTP+fluoxetine group improved significantly more rapidly on insomnia scores. From baseline to first follow up visit, P = 0.00055; to second follow up visit, P = 0.0004; to third follow up visit, P = 0.01.Sedation was more prevalent in the QTP+fluoxetine group, P = 0.006.QTP is effective in reducing symptoms of insomnia in patients with depression.
Keshavan et al. (2007)QTP group: mean 36.1, S.D. 9.8SchizophreniaCross-sectional, QTP 313.33 ± 228.71 mg, vs. risperidone 3.25 ± 2.12 vs. neuroleptic-naïve patients. N = 39 (patients already stabilized on QTP or risperidone), N = 31 (neuroleptic-naïve patients)REM counts were elevated in the QTP than in neuroleptic-naïve patients. QTP and risperidone treated patients had more prominent SWS and % of stage N2, and reduced REM sleep than never-treated schizophrenia subjects.Not analyzed.QTP suppresses REM sleep in patients with schizophrenia. Its therapeutic significance requires further investigation.
Juri et al. (2005)Mean: 67.6, S.D.: 8.4Parkinson’s disease without psychosis with insomnia12-wk open-label trial. Mean QTP dose 31.9 mg/day, range 12.5–50 mg/day. N = 14.PSQI reduced by mean ± S.D. 3.8 ± 3.9, P < 0.01. SOL reduced from 82 ± 65.4 minutes to 28.6 ± 22.7 on last visit, P < 0.05.Two discontinuations due to restless legs syndrome that worsened since the beginning of treatment. Two subjects also reported worsened sleepiness during the day. No worsening of motor symptoms or orthostatic symptoms.QTP is effective at reducing symptoms of insomnia in Parkinson’s disease patients with insomnia.
McElroy et al. (2010)18+Type I or Type II bipolar depression8-wk RCT. QTP 300 mg/day vs. QTP 600 mg/day vs. paroxetine 20 mg/day. N = 740.MADRS item 4 (reduced sleep) improved significantly more in both QTP arms than in placebo. In contrast, the paroxetine arm was not significantly superior to placebo in reducing item four scores.AEs leading to treatment discontinuation were reported in 9.1% of QTP 300 mg/day, 12.3% of QTP 600 mg/day, 13.2% of paroxetine, and 8.1% of placebo. Incidence of serious AEs lowest in QTP 300 mg/day, while those treated with paroxetine displayed the highest.QTP is more effective than paroxetine at reducing symptoms of insomnia in bipolar depression.
Pasquini et al. (2009)19–65Breast cancer with insomnia induced by tamoxifenRetrospective open-label trial. QTP dose <200 mg/day. N = 6.Weight increased by 4.9 pounds (P = 0.037). BMI increased by .Eight points (P = 0.048). There were no significant differences between baseline and endpoint metabolic parameters when examined by baseline BMI, age category, psychiatric diagnosis, or concomitant psychotropic medication.Reported side effects included weight gain (N = 2) and dizziness (N = 1).QTP increases weight gain in patients treated for insomnia.
Robert et al. (2005)49–68Sleep disturbances in combat veterans with DSM-IV PTSD6-wk open-label trial. QTP mean 100 ± 70 mg/day, range 25–300 mg/day. N = 19.Global PSQI scores decreased significantly, 15.82 ± 2.72 at baseline to 7.89 ± 5.15 at week 6, P < 0.001. Sleep quality improved, P = 0.006. Sleep latency improved, P = 0.002. Total sleep time increased from 4.0 ± 1.0 to 6.0 ± 1.8 h per night, P < 0.001.Sedation was reported by 36.8% of patients, leading to discontinuation in one patient.QTP may reduce symptoms of insomnia in patients with PTSD.
Šagud et al. (2006)18+Treatment-resistant DSM-IV depression20-wk open-label trial of QTP as augmentation of antidepressants. Mean QTP dose 315 mg/day. N = 14.QTP significantly improved the anxiety and insomnia subscales of the HAM-D. Insomnia scores of HAM-D was significantly reduced from baseline after 20 wk of treatment, P < 0.05.Three patients had hypotension and two had daytime sedation, transient and mild.QTP is effective in reducing symptoms of insomnia in patients with depression.
Tassniyom et al. (2010)25–62Primary insomnia by DSM-IV2-wk RCT. QTP 25 mg/day vs. placebo. N = 16.Increases in sleep time: placebo = 72.24 minutes vs. QTP = 124.92 minutes (P = 0.193). Reductions in SOL: placebo = 23.72 minutes vs. QTP = 96.16 minutes (P = 0.070). Trend for improvement was shown though did not react significant difference.Two patients in QTP group reported dry lips, dry tongue, and morning drowsiness.QTP may be effective at reducing symptoms of insomnia.
Terán et al. (2008)NSInsomnia during detoxification in substance abusersRetrospective chart review. QTP 25–225 mg/day. N = 52 medical records.Global Spiegel Sleep Questionnaire (SSQ) scores significantly improved throughout the 60-day follow up period, P < 0.001. Greatest improvement occurred in first week of treatment and remained constant thereafter.No patients dropped out due to AEs. Most common AE was dry mouth (34.6%).QTP is effective at reducing symptoms of insomnia during detoxification from substance abuse.
Todder et al. (2006)21–76Treatment-resistant unipolar or bipolar depression compared with healthy controls4-wk open-label follow up study of QTP augmentation of antidepressants. QTP 50–800 mg/day. N = 54.Objective actigraphic sleep analysis: no significant difference was found between Weeks 1 and 4. SE did not change. Actual sleep time was higher at all time points in patients compared with controls, however, SOL was significantly higher in controls compared to patients. Subjective sleep analysis with PSQI: statistically significant improvements of total sleep score, quality of sleep, daytime sleepiness, between the week before admission, Week 1, and Week 2. SOL improved between Weeks 1 and 4.Not analyzed.QTP may be effective at reducing symptoms of insomnia in patients with depression.
Wiegand et al. (2008)NSPrimary insomnia6-wk open-label study. QTP 25–75 mg/day. N = 18.Total sleep time (minute) increased from 358.0 ± 61.4 at baseline to 395.6 ± 62.3 at 6 w, P = 0.03. SOL (minute) was 22.1 ± 17.0 at baseline and 24.2 ± 19.0 at 6 wk (P = 0.83). PSQI total score was reduced from 13.1 ± 2.3 at baseline to 6.8 ± 3.3 at 6 wk, P = 0.00.Dry mouth and transient hangover symptoms were recorded most frequently.QTP is effective at reducing symptoms of insomnia.