In the United States, Sominex is marketed by Prestige Brands,[1] sometimes under their subsidiary Medtech Products, Inc.,[2] and has as its active ingredient diphenhydramine hydrochloride.
[5] However, a 2019 manual for counseling professionals in Canada included Sominex as a medicine to be used for the treatment of Parkinson's tremors and stiffness related to the condition in addition to its usage as an antihistamine.
[10][non-primary source needed] Diphenhydramine and promethazine are both marketed by names other than Sominex for several indications including and besides their use as sleep aids.
One ad spot featured the image of the sleeping pill tablet itself as a classic bouncing ball to follow the lyrics of their jingle, shown on the lower third of the screen.
[16] Congressman John Blatnik had previously revealed that the manufacturer of Sominex, Pharmaceuticals, Inc., was selling lemon-flavored skim milk under the brand name of RDX, US¢7 product they sold for US$3.00 per bottle.
[18] In 1971, Sominex was a combination of scopolamine aminoxide hydrobromide, methapyrilene hydrochloride, and salicylamide,[19] the last of which is noted as a pain killer,[20] and comprised the largest part of the formula.
[39] Television advertisements for Sominex 2 in 1983, manufactured by Beecham, made specific claims as to the effectiveness and physician preference for diphenhydramine.
[43] Competing with GSK in the UK, Actavis ran an ad in 2010 for Sominex—their first television promotional campaign for the drug—in an attempt to increase the market share for their formulation of Sominex.
[8] The promethazine formula of Sominex was included in a recall issued in 2010 in the United Arab Emirates by Ministry of Health and Prevention Ministerial Decree No.
Clinic trials of this class of drug versus a placebo have shown that the medication can affect attention, motor control, and memory.
[49] In 1972, Sominex included methapyrilene, a drug known to cause nausea, vomiting, hypotension and central nervous system depression, among other effects, when taken in excess.
[58][19] In 1971, FDA Commissioner Dr. Charles Edwards testified before Congress that Sominex, as it was then-formulated in the U.S., was no more effective than a placebo and noted that some users could experience hallucinations.
[60] Promethazine has been determined at 20mg dosages to increase sleep duration through apparent direct effect on the brain rather than simply clearing congestion.
[62] In 1986, a patient who had taken 1600 mg of Sominex 2 daily for a period of one month led his physicians to question whether additional caution should be taken with respect to abuse potential.
[64] An FAA report found that between 2012 and 2016, diphenhydramine was the most common pharmaceutical known to cause impairment detected in post-mortem toxicology tests performed on someone who may have been in charge of the aircraft at the time of a fatal plane crash, specifically naming both Benadryl and Sominex.
[65] A 2016 recommendation regarding possibly misused over-the-counter medications indicated that the generic diphenhydramine had the potential to be over-utilized by patients and suggested changing it to a behind-the-counter class drug.
[68] An interview following the documentary's release with the medical director of UCI Health Sleep Medicine Services revealed that no studies have been done regarding the Sominex brand's possible long-term effects as it is only intended for short-term use.