Related Experiment Video
Updated: Feb 19, 2026

Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
Published on: February 17, 2023
Real-world analysis of gender differences in drug-induced insomnia: evidence from FAERS and CVARDD databases
Yuntai Wang1,2, Shengjie Wang1,2, Fuxing Liu1,2
1Department of Rehabilitation Medicine, Hubei Provincial Hospital of Integrated Chinese and Western Medicine, Wuhan City, Hubei Province, China.
Background:
Insomnia is a common sleep disorder that substantially impairs quality of life. Drug-induced insomnia (DII), an important cause of secondary insomnia, is often underrecognized, and many potential signals are not yet documented in drug labels. Evidence regarding sex-specific differences in DII remains limited, hindering the development of tailored safety strategies.
Objective:
To identify drug-insomnia associations, assess sex-specific differences, validate signals in an independent database, and characterize the time-to-onset (TTO) of high-risk drugs using large-scale real-world pharmacovigilance data.
Methods:
We conducted a retrospective observational pharmacovigilance study using insomnia-related reports from FAERS (2004Q1-2025Q2). Disproportionality analyses (ROR, PRR, BCPNN, MGPS) were performed, and sex-stratified associations were compared using Wald chi-square tests. Signals were externally validated in the Canadian Vigilance Adverse Reaction Database (CVARDD). Weibull models were applied to evaluate TTO for the drugs with the highest insomnia report counts.
Results:
A total of 266,429 insomnia-related reports were identified, with more reports from females (60.1%) than males (32.0%). A total of 237 drugs demonstrated significant disproportionality signals, including several without labeled insomnia risk. Among the 20 most frequently implicated drugs, 15 showed significant sex-drug interactions. Duloxetine exhibited a stronger association in males, whereas niraparib and levothyroxine showed higher risks in females. External validation confirmed 124 overlapping drugs with consistent signals. TTO analyses revealed an early-failure pattern (Weibull β < 1) for all five high-reporting drugs, with median onset ranging from 3 to 211.5 days.
Conclusion:
This study identified multiple drug-insomnia signals, quantified sex-specific differences, and validated findings in an independent database. These results underscore the importance of recognizing DII and monitoring sex-related variability in clinical practice.
Related Concept Videos
Substance Use Disorders Affecting Sleep
Understanding the concepts of physical dependence,...
Management of Insomnia
Sedatives and Hypnotics Drugs: Miscellaneous Agents
Melatonin congeners like ramelteon (Rozerem) and tasimelteon (Hetlioz) selectively bind to melatonin receptors (MT1 and MT2) and thus mimic the actions of melatonin, a hormone that regulates sleep-wake cycles. Tasimelteon is primarily used for non-24-hour sleep-wake disorder, common in blind patients. They are also used to treat conditions like insomnia...
Blind Procedures
Insomnia
Multiple factors contribute...
Chronopharmacokinetics: Circadian Rhythms and Influence on Drug Response
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...

