A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00666770

Enrollment

309

Registered

2008-04-25

Start date

2004-10-31

Completion date

2004-11-30

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient Insomnia

Brief summary

The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.

Interventions

DRUGGabapentin

Gabapentin 250 mg oral capsule 30 minutes prior to bedtime

DRUGPlacebo

Matched placebo 30 minutes prior to bedtime

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Aged \>/= 18 years * Females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening

Exclusion criteria

* Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition) * Recreational drug use within past 30 days

Design outcomes

Primary

Measure	Time frame
Latency to persistent sleep as measured by polysomnography	Hour +8

Secondary

Measure	Time frame
Subjective total sleep time	Hour +8
Subjective assessment of sleep refreshment	Hour +8
Subjective assessment of sleep quality	Hour +8
Stanford Sleepiness Scale	Hour +13
Karolinska Sleep Diary-Sleep (KSD) Quality Index	Hour +8
KSD individual scores	Hour +8
Digit Symbol Substitution Test	Hour +8
Latency to REM sleep	Hour +8
Number of awakenings	Hour +8
Wake after sleep onset	Hour +8
Subjective wake after sleep onset	Hour +8
Total sleep time	Hour +8
Sleep efficiency	Hour +8
Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep	Hour +8
Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)	Hour +8
Vital signs	Hour +8
Adverse events	Hour +13
Sleep onset latency	Hour +8
Percent slow wave sleep (Stages 3&4 combined)	Hour +8
Subjective sleep latency	Hour +8
Subjective number of awakenings	Hour +8
Total wake time plus Stage 1 sleep	Hour +8

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026