Sominex

What is Sominex?

Sominex is an over-the-counter medication primarily used to alleviate temporary sleep disturbances. It contains promethazine hydrochloride, an antihistamine, as the active ingredient. It works by reducing the time needed to fall asleep and increases the depth of sleep.

Active Ingredients

The active ingredient in Sominex is promethazine hydrochloride, which is a first-generation H1-receptor antagonist with pronounced sedative effects. It can also exhibit significant anticholinergic activity.

Available Formulations

Sominex is available as tablets. Each Sominex tablet typically contains 25 mg of promethazine hydrochloride.

Indications for Use

Indicated for short-term treatment of sleep disorders in adults. It is recommended when occasional sleeplessness causes difficulty falling asleep.

Pharmacodynamics

Promethazine, the active component, is a phenothiazine derivative that possesses antihistaminic, sedative, anticholinergic, and antiemetic properties. Its sedative effects result from its antagonism of histamine H1 receptors in the brain.

Pharmacokinetics

After ingestion, promethazine is well-absorbed through the gastrointestinal tract. It undergoes extensive hepatic metabolism and is excreted primarily in the urine. Peak plasma concentrations are reached within 2 to 3 hours post-administration.

Dosage and Administration

For adults and children aged 16 years and over, the usual dose is one tablet at bedtime. The tablet should be swallowed with water.

Special Populations

Children under 16 years, the elderly, and those with underlying health conditions should consult a healthcare provider before using Sominex.

Drug Interactions

Promethazine should not be taken with other sedative medications including benzodiazepines, opioids, or other antihistamines. Concomitant use of alcohol should be avoided due to the increased sedative effect.

Adverse Drug Reactions

Common side effects of Sominex include drowsiness, dizziness, dry mouth, blurred vision, constipation, and urinary retention. These are due to its anticholinergic effect.

Overdosage

In the event of overdosage, the symptoms may include severe drowsiness, confusion, convulsions, and respiratory depression. Immediate medical attention is required, and supportive measures, alongside symptomatic and supportive therapy, should be administered.

Storage Conditions

Sominex should be stored in a dry place at room temperature. It should also be kept out of reach and sight of children.

Proper Disposal

Unused or expired tablets should be properly disposed of, in accordance with local regulations, to prevent accidental consumption or environmental harm.

Patient Counseling Information

Patients should be counseled about the potential for next-day drowsiness, the risks of engaging in activities requiring mental alertness, and the importance of establishing a conducive sleep environment. They should also be advised about the potential for anticholinergic-related side effects.

Monitoring Parameters

While Sominex is typically used on an as-needed basis, individuals using it should be monitored for effectiveness and adverse effects, especially if used with other medications or by special populations.

Regulatory Status

Sominex is an over-the-counter medication, but its use should still be compliant with the indications and dosages specified by healthcare regulatory authorities.