Occasional Sleeplessness
Conditions
Brief summary
The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.
Detailed description
Diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of the ethanolamine classes with known sleep-inducing properties and is approved by the Food & Drug Administration to reduce the time to sleep onset in individuals having difficulty falling asleep. The goal of the study is to investigate diphenhydramine versus placebo with regard to several sleep parameters, including time to sleep onset, in healthy adult subjects suffering from occasional sleeplessness.
Interventions
30 mL at bedtime
DRUGPlacebo
30 mL at bedtime
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* be male or female subjects, ≥18 years of age to 55 years of age, who report that they are currently experiencing occasional sleeplessness characterized by difficulty initiating sleep (ie, taking ≥30 minutes to fall asleep) on average 2-4 times per week for less than 1 month; * be in good general health without clinically significant disease (no previously diagnosed sleep disorders); * if female, have a negative screening pregnancy test and agree to be on approved methods of birth control throughout the study
Exclusion criteria
* have a clinically significant illness within 30 days of Screening; * are taking medication that could interfere with the study medication; * have been under a clinician's care for insomnia treatment and control within the past year or has a history of insomnia or is currently taking prescription medications for insomnia; * are currently taking medications known to effect sleep function; * have current or past history of serious, severe or unstable physical or psychiatric illness; * have current diagnosis of severe urinary retention; * have current diagnosis of untreated narrow angle glaucoma; * had participated in a clinical drug study or used an investigational new drug during the previous 30 days; * have any clinically significant or abnormal finding in physical examination, vital signs, ECG, or clinical laboratory tests that may affect the subject's safety or outcome of the study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Latency to Persistent Sleep | 4 weeks | Per Protocol population based on subjects who completed treatment crossover |
Participant flow
Recruitment details
Participants were recruited at Henry Ford Medical Hospital, Detroit MI, USA between October 2013 to December 2014.
Pre-assignment details
43 subjects screened. 33 subjects received product (ie, enrolled, for the purposes of this reporting), of whom 2 withdrew but re-enrolled (per protocol amendment). These 2 subjects are counted as starting each sequence in the table below, bringing total started to 35 and for AEs to 30 and 29 (DPH and placebo, respectively.) 25 subjects completed.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Entire Study Population Includes groups that received Placebo and Drug First | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (First of Crossover) | Did not meet Phase 2 eligibility | 4 | 4 |
| Period 1 (First of Crossover) | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 9.64 |
| Body Mass Index (BMI) | 25.9 kg/m2 STANDARD_DEVIATION 4.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 66.4 inches STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 8 Participants |
| Weight | 163.3 lb STANDARD_DEVIATION 34.29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 30 | 7 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
Primary
Mean Latency to Persistent Sleep
Per Protocol population based on subjects who completed treatment crossover
Time frame: 4 weeks
Population: Subjects with evaluable data for mean latency to persistent sleep for both treatment periods were included in the efficacy analysis provided they meet the other defined Per Protocol criteria. All data for each treatment and endpoint were averaged for all days in which the study medication was taken in a given treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diphenhydramine Hydrochloride | Mean Latency to Persistent Sleep | 19.1 minutes | Standard Error 3.1 |
| Placebo | Mean Latency to Persistent Sleep | 27.1 minutes | Standard Error 3.1 |
p-value: 0.0312ANCOVA