Allowed Concomitant Medications Sample Clauses

Allowed Concomitant Medications. It is ideal to have all patients participating in the study go without any hypnotic agents for the entire double-blind period of the study. Yet there may be instances in which patients’ insomnia symptoms need to be addressed with a concomitant treatment. In these instances, the Investigator should recommend use of an antihistamine-based OTC hypnotic, such as Benadryl® or generic diphenhydramine 25-50 mg, for a limited period (e.g. no more than a few nights in a row). Patients should be asked to keep track of their use of such sleeping remedies, and again, chronic nightly use should be avoided whenever possible. Melatonin is considered an allowable concomitant medication but its usage should have been stable for at least 30 days prior to baseline and usage should remain stable during the study. If diphenhydramine is ineffective, the treating Investigator should contact the medical monitor to discuss alternative options. Allergy medications and cold remedies containing adrenergic agonist decongestants such as pseudoephedrine or phenylephrine should be avoided unless absolutely necessary (and in such cases when considered absolutely necessary, they should be avoided in the evening or at bedtime to minimize their interference with sleep). Sympathomimetics such as adrenergic agonist decongestants have the potential to acutely worsen PTSD symptoms and therefore could confound the assessment of TNX-102 SL versus placebo for treatment of PTSD. Other prescription or over-the-counter medications not specifically excluded by entry criteria typically may be continued during the study, with the expectation that chronic medications should have been used in a stable fashion for at least 30 days prior to randomization. Sites should contact the medical monitor for any questions about whether a concomitant medication may be continued during the study or if it would be acceptable to taper an excluded medication.