Zolpidem extended-release improves sleep and next-day symptoms in comorbid insomnia and generalized anxiety disorder.
A multicenter, double-blind, parallel-group study was designed to assess the efficacy and safety of zolpidem extended-release coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Patients (N = 383) received open-label escitalopram 10 mg/d and were randomized to either adjunct zolpidem extended-release 12.5 mg or placebo. The primary efficacy measure was change from baseline to week 8 in subjective total sleep time. Secondary efficacy measures included subjective sleep onset latency, number of awakenings, wake time after sleep onset, sleep quality, the Hamilton Rating Scale for Anxiety, the Beck Anxiety Inventory, the Sleep Impact Scale, the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire, and the Sheehan Disability Scale. The last-observation-carried-forward method was used to impute missing values for most efficacy measures. Safety was monitored at each visit. At week 8 and all time points, there was a significant improvement in the zolpidem extended-release/escitalopram group compared with placebo/escitalopram for total sleep time (P < 0.0001). Most of the secondary efficacy measures also significantly favored zolpidem at most visits (P < 0.0001). The most common treatment-emergent adverse events in both groups were nausea, dizziness, headache, fatigue, and dry mouth. Concurrent zolpidem extended-release/escitalopram, compared with placebo/escitalopram, significantly improved insomnia and sleep-related next-day symptoms, but not anxiety symptoms, in patients with comorbid insomnia and generalized anxiety disorder.
Fava
Maurizio
M
Depression Clinical and Research Program, Massachusetts General Hospital, Boston, MA 02114-2696, USA. MFAVA@PARTNERS.ORG
Asnis
Gregory M
GM
Shrivastava
Ram
R
Lydiard
Bruce
B
Bastani
Bijan
B
Sheehan
David
D
Roth
Thomas
T
D000328:Adult; D001008:Anxiety Disorders / Q000150:complications / Q000188:drug therapy; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D007319:Sleep Initiation and Maintenance Disorders / Q000150:complications / Q000188:drug therapy*; D055815:Young Adult; D000077334:Zolpidem
D015283:Citalopram; D003692:Delayed-Action Preparations; D006993:Hypnotics and Sedatives; D011725:Pyridines; D017367:Selective Serotonin Reuptake Inhibitors; D000077334:Zolpidem