Caffeine

Generic Name: Caffeine

Brand Names: Anacin, Arthriten Inflammatory Pain, Ascomp, Bc Arthritis, Bc Original Formula, Cafcit, Diurex, Dvorah, Esgic, Exaprin, Excedrin, Excedrin Tension Headache, Fioricet, Fioricet With Codeine, Fiorinal, Goody's Extra Strength, Goody's Headache Relief Shot, Goody's PM, Midol Complete, Midol Cramps & Bodyaches, Migergot, Norgesic, Norgesic Forte, Orbivan, Orphengesic, Pamprin Max Formula, Peyona, Stanback Headache Powder Reformulated Jan 2011, Trezix, Trianal, Trianal C, Triatec, Triatec-8, Vanatol, Vanatol S, Vanquish, Vivarin, Peyona (previously Nymusa), Gencebok

Drug Type: Small Molecule

Chemical Formula: C_₈H_₁₀N_₄O_₂

CAS Number: 58-08-2

Unique Ingredient Identifier: 3G6A5W338E

Background: Caffeine is a drug of the methylxanthine class used for a variety of purposes, including certain respiratory conditions of the premature newborn, pain relief, and to combat drowsiness. Caffeine is similar in chemical structure to Theophylline and Theobromine. It can be sourced from coffee beans, but also occurs naturally in various teas and cacao beans, which are different than coffee beans. Caffeine is also used in a variety of cosmetic products and can be administered topically, orally, by inhalation, or by injection.

The caffeine citrate injection, used for apnea of the premature newborn, was initially approved by the FDA in 1999. According to an article from 2017, more than 15 million babies are born prematurely worldwide. This correlates to about 1 in 10 births. Premature birth can lead to apnea and bronchopulmonary dysplasia, a condition that interferes with lung development and may eventually cause asthma or early onset emphysema in those born prematurely. Caffeine is beneficial in preventing and treating apnea and bronchopulmonary dysplasia in newborns, improving the quality of life of premature infants.

Indication: Caffeine is indicated for the short term treatment of apnea of prematurity in infants and off label for the prevention and treatment of bronchopulmonary dysplasia caused by premature birth. In addition, it is indicated in combination with sodium benzoate to treat respiratory depression resulting from an overdose with CNS depressant drugs. Caffeine has a broad range of over the counter uses, and is found in energy supplements, athletic enhancement products, pain relief products, as well as cosmetic products.

Associated Conditions: Acute Pain, Chronic Lung Disease of Prematurity, Common Cold, Dyspepsia, Fatigue, Fever, Flu caused by Influenza, Headache, Menstrual Pain, Myalgia, Pain, Pain caused by Rheumatism, Primary apnea of premature newborns, Respiratory Depression, Somnolence, Tension Headache, Toothache, Under-eyes Dark Circles, Vascular Headaches, Moderate Pain

Associated Therapies: Analgesia, Antacid therapy, Athletic Performance

Clinical Trials

A Study to Determine if Caffeine Accelerates Emergence From Propofol Anesthesia

Phase 4

Completed

Conditions: Anesthesia

Interventions: Drug: Placebo
Drug: Caffeine

First Posted Date: 2017-12-04

Last Posted Date: 2019-11-18

Lead Sponsor: University of Chicago

Target Recruit Count: 8

Registration Number: NCT03360903

Locations: 🇺🇸
The University of Chicago, Chicago, Illinois, United States

Intermittent Hypoxia and Caffeine in Infants Born Preterm

Phase 2

Completed

Conditions: Intermittent Hypoxia

Interventions: Drug: Placebos
Drug: Caffeine

First Posted Date: 2017-10-26

Last Posted Date: 2023-09-01

Lead Sponsor: Children's National Research Institute

Target Recruit Count: 170

Registration Number: NCT03321734

Locations: 🇺🇸
Children's National Medical Center/Children's Research Institute, Washington, District of Columbia, United States
🇺🇸
Loma Linda University Health System, Loma Linda, California, United States
🇺🇸
University of Massachusetss, Worcester, Massachusetts, United States

and more 12 locations

Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

Phase 1

Completed

Conditions: NASH

Interventions: Drug: Midazolam
Drug: Caffeine
Drug: Rosuvastatin
Drug: EDP-305

First Posted Date: 2017-06-15

Last Posted Date: 2017-08-21

Lead Sponsor: Enanta Pharmaceuticals, Inc

Target Recruit Count: 24

Registration Number: NCT03187496

Locations: 🇺🇸
Pharmaceutical Research Associates, Inc.,, Lenexa, Kansas, United States

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Phase 1

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: BMS-986195
Drug: Methotrexate
Drug: Caffeine
Drug: Montelukast
Drug: Leucovorin
Drug: Flurbiprofen
Drug: Omeprazole
Drug: Midazolam
Drug: Digoxin
Drug: Pravastatin

First Posted Date: 2017-04-27

Last Posted Date: 2017-12-15

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 26

Registration Number: NCT03131973

Locations: 🇺🇸
PPD Development, LP, Austin, Texas, United States

The Effects of Caffeine Withdrawal on Migraine

Phase 2

Terminated

Conditions: Migraine
Caffeine Withdrawal

Interventions: Drug: Caffeine

First Posted Date: 2017-01-18

Last Posted Date: 2019-07-23

Lead Sponsor: Nordlandssykehuset HF

Target Recruit Count: 10

Registration Number: NCT03022838

Locations: 🇳🇴
Departement of Neurology, Tromsø, Norway
🇳🇴
Departement of Neurology, NLSH HF, Bodø, Norway
🇳🇴
Nordland Hospital, Bodø, Norway

Ibuprofen/Caffeine Lower Back or Neck Pain Study

Phase 3

Completed

Conditions: Back Pain
Neck Pain

Interventions: Drug: ibuprofen
Drug: placebo
Drug: caffeine

First Posted Date: 2016-12-26

Last Posted Date: 2019-06-07

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 635

Registration Number: NCT03003000

Locations: 🇩🇪
Praxis Dr. Steinebach, Essen, Essen, Germany
🇩🇪
Praxis Dr. Pabst, Gilching, Gilching, Germany
🇩🇪
Praxis Dr. Klein, Künzing, Künzing, Germany

and more 15 locations