P-081 - (Poster #81) Clinical Evidence with the Combination of Ibuprofen and Diphenhydramine for the Management of Pain and Sleeplessness

Based on Center for Disease Control (CDC) data approximately 35% of the population does not get enough sleep.¹ The CDC recommends that adults from 18 to 60 years of age should get 7 hours of sleep per day, and children and older adults are recommended to get even more sleep.² Inadequate sleep can have a significant impact on health, including effects on immunity, metabolism, stress, heart health, risk for chronic conditions, and cognitive function.³ Pain is a major contributor to sleeplessness, and sleeplessness can contribute to pain.  Both acute and chronic pain can lead to sleeplessness, and if not managed, the combination of pain and sleeplessness can play a role in onset of disability.^4,5,6,7

Purpose/Objectives:

There are a broad range of options to independently treat pain and sleeplessness, which include over-the-counter (OTC) and prescription (Rx) products. There are also a number of combination products that include an analgesic and a sleep aid, including readily accessible OTC products. One of the most frequently used combinations with a long history of managing pain and sleeplessness includes ibuprofen/diphenhydramine (IBU/DPH). In this analysis, we evaluate the IBU/DPH data compared to placebo (PBO) from four clinical studies of subjects with pain and sleeplessness.

Methods:

Four placebo (PBO)-controlled clinical studies were conducted with solubilized IBU/DIPH 400/50 mg per dose.  Subjects were post-third molar extraction with moderate to severe pain experiencing sleeplessness. We evaluated common study endpoints including duration of sleep, onset of sleep, global rating of sleep, and use of rescue medicine.

Results:

In four studies, the range of subjects with duration of sleep >6 hours with IBU/DIPH was 57%-70% versus PBO 3%-15%. Average minutes to sleep was 30.8-45 minutes with IBU/DIPH versus 63.8- >180 minutes with PBO. Global assessment of sleep was rated as good, very good, or excellent for 51.6%-79.3% with IBU/DIPH versus 2.5%-14.6% with PBO. Average time to use of rescue medication was >12 hours with IBU/DIPH versus ≤2.1 hours with PBO, and rescue medication was 33.6%-45.8% with IBU/DIPH versus 81%-95% with PBO.

Conclusions/Implications for future research and/or clinical care:

Pain and sleeplessness are commonly experienced and can have long term impacts on health. Solubilized IBU/DIPH is a well-established treatment for pain with sleeplessness. In the studies evaluated, the product consistently provided longer duration of sleep, faster onset of sleep, a better global sleep experience, and less rescue medication use. The improved total sleep experience allows the user to optimize the benefits of sleep on overall health.

1.) Data Source: CDC Behavioral Risk Factor Surveillance System (BRFSS), 2013–2022. FastStats: Sleep in Adults | Sleep | CDC.

2.) CDC, Sleep, Getting Enough Sleep. About Sleep | Sleep | CDC.

3.) CDC, Sleep, Benefits of Sleep. About Sleep | Sleep | CDC.

4.) McBeth J, Wilkie R, Bedson J, et al.  Sleep disturbance and chronic widespread pain.  Curr Rheumatol Rep. 2015 Jan;17(1):469.

5.) Cho SJ, Song TJ, Chu MK.  Sleep and Tension-Type Headache.  Curr Neurol Neurosci Rep. 2019 May 30;19(7):44.

6.) Okifuji K, Hare BD.  Do sleep disorders contribute to pain sensitivity?  Curr Rheumatol Rep. 2011 Dec;13(6):528-34.

7.) Sivertsen B, Lallukka T, Petrie KJ, et al.  Sleep and pain sensitivity in adults.  Pain. 2015 Aug;156(8):1433-1439.