A Phase 3 interventional study of Gabapentin and Gabapentin in Transient Insomnia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 309 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Gabapentin
Drug: Gabapentin
Drug: Placebo
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
Matched placebo 30 minutes prior to bedtime
Latency to persistent sleep as measured by polysomnography
Time frame: Hour +8
Subjective wake after sleep onset
Time frame: Hour +8
Subjective total sleep time
Time frame: Hour +8
Subjective assessment of sleep refreshment
Time frame: Hour +8
Subjective assessment of sleep quality
Time frame: Hour +8
Stanford Sleepiness Scale
Time frame: Hour +13
Karolinska Sleep Diary-Sleep (KSD) Quality Index
Time frame: Hour +8
KSD individual scores
Time frame: Hour +8
Digit Symbol Substitution Test
Time frame: Hour +8
Latency to REM sleep
Time frame: Hour +8
Number of awakenings
Time frame: Hour +8
Wake after sleep onset
Time frame: Hour +8
Total wake time plus Stage 1 sleep
Time frame: Hour +8
Total sleep time
Time frame: Hour +8
Sleep efficiency
Time frame: Hour +8
Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep
Time frame: Hour +8
Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
Time frame: Hour +8
Vital signs
Time frame: Hour +8
Adverse events
Time frame: Hour +13
Sleep onset latency
Time frame: Hour +8
Percent slow wave sleep (Stages 3&4 combined)
Time frame: Hour +8
Subjective sleep latency
Time frame: Hour +8
Subjective number of awakenings
Time frame: Hour +8
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.