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This study provides Class I evidence that suvorexant improves sleep efficiency over 4 weeks in nonelderly adult patients with primary insomnia.

Introduction We evaluated the clinical profile of the orexin receptor antagonist suvorexant for treating insomnia in patients with mild‐to‐moderate probable Alzheimer's disease (AD) dementia. Methods Randomized, double‐blind, 4‐week trial of suvorexant 10 mg (could be increased to 20 mg based on clinical response) or placebo in patients who met clinical diagnostic criteria for both probable AD dementia and insomnia. Sleep was assessed by overnight polysomnography in a sleep laboratory. The primary endpoint was change‐from‐baseline in polysomnography‐derived total sleep time (TST) at week 4. Results Of 285 participants randomized (suvorexant, N = 142; placebo, N = 143), 277 (97%) completed the trial (suvorexant, N = 136; placebo, N = 141). At week 4, the model‐based least squares mean improvement‐from‐baseline in TST was 73 minutes for suvorexant and 45 minutes for placebo; (difference = 28 minutes [95% confidence interval 11‐45], p < 0.01). Somnolence was reported in 4.2% of suvorexant‐treated patients and 1.4% of placebo‐treated patients. Discussion Suvorexant improved TST in patients with probable AD dementia and insomnia.

Aims-To compare the tolerability and eYcacy of a fixed combination solution of dorzolamide/timolol (Cosopt), administered twice daily with the concomitant administration of its components, dorzolamide (Trusopt) twice daily and timolol (Timoptic) twice daily. Methods-After a 2 week timolol run in, patients with open angle glaucoma or ocular hypertension were randomised (1:1) to receive treatment with either the dorzolamide/timolol combination solution twice daily (combination) or the dorzolamide solution twice daily plus timolol maleate solution twice daily (concomitant) for 3 months. Results-299 patients were entered and 290 patients completed the study. Compared with the timolol baseline, additional IOP lowering of 16% was observed at trough (hour 0) and 22% at peak (hour 2) at month 3 in both the concomitant and combination groups. The IOP lowering eVects of the two treatment groups were clinically and statistically equivalent as demonstrated by the extremely small point diVerences (concomitant − combination) observed in this study−0.01 mm Hg at trough and 0.08 mm Hg at peak. The safety variables of the concomitant and combination groups were very similar. Both combination and concomitant therapy were well tolerated and few patients discontinued due to adverse eVects. Conclusions-Thedorzolamide/timolol combination solution administered twice daily is equivalent in eYcacy and has a similar safety profile to the concomitant administration of the components administered twice daily. (Br J Ophthalmol 1998;82:1249-1253 The safety and eYcacy of timolol maleate (Timoptic) and dorzolamide hydrochloride (Trusopt) as monotherapy agents to lower intraocular pressure (IOP) has been demonstrated in previous clinical investigations. 1 Timolol maleate remains the most widely prescribed treatment for elevated IOP in patients with open angle glaucoma or ocular hypertension. However, since open angle glaucoma is a chronic progressive disease, the majority of patients eventually require additional medication for control of IOP. In previous clinical studies, dorzolamide demonstrated a clinically significant additive eVect ranging from a 13-21% further reduction in IOP when added to ophthalmic blockers.2 3 This additive effect supported the development of a combination solution of dorzolamide and timolol (Cosopt), which is administered twice daily. Other agents additive to timolol (such as pilocarpine, adrenaline (epinephrine), and oral carbonic anhydrase inhibitors) have side eVects which may often result in discontinuation. However, the discontinuation rate due to side eVects has been low with dorzolamide and timolol.4 5 In a crossover study, patients preferred therapy with dorzolamide and timolol to therapy with pilocarpine and timolol by more than 7:1. 4 This combination product may also improve patient compliance with therapy since compliance decreases as the dosing frequency increases. Thus, a twice daily combination solution should lead to improved compliance compared with concomitant therapy with timolol and eit...