A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment

A 3-Month, Open-Label, Pharmacy-Based, Actual-Use Trial in a Simulated Over-The-Counter (OTC) Environment to Assess Self-Selection and Consumer Use Patterns of Gabapentin 250 mg for Occasional Sleeplessness

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00659100

Enrollment

1254

Registered

2008-04-16

Start date

2006-08-31

Completion date

2007-01-31

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 consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.

Interventions

DRUGGabapentin

Gabapentin 50 mg oral capsule 30 minutes before bedtime

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age of 18 years or older with symptoms of sleeplessness * Provided informed consent

Exclusion criteria

* Contraindications to use of gabapentin

Design outcomes

Primary

Measure	Time frame
Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)	Throughout Day 90
Subject compliance with directions for use (number of capsules per dose and the number of doses per day)	Throughout Day 90

Secondary

Measure	Time frame
Adverse events	Duration of study

Countries

United States

Outcome results

None listed

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