Current Phase II investigational therapies for insomnia.

Authors :: Zisapel N
Source :: Expert opinion on investigational drugs [Expert Opin Investig Drugs] 2015 Mar; Vol. 24 (3), pp. 401-11. Date of Electronic Publication: 2014 Nov 25.
Publication Year :: 2015
Abstract: Introduction: Insomnia is typified by a difficulty in sleep initiation, maintenance and/or quality (non-restorative sleep) resulting in significant daytime distress.<br />Areas Covered: This review summarizes the available efficacy and safety data for drugs currently in the pipeline for treating insomnia. Specifically, the authors performed MEDLINE and internet searches using the keywords 'Phase II' and 'insomnia'. The drugs covered target GABAA (zaleplon-CR, lorediplon, EVT-201), orexin (filorexant, MIN-202), histamine-H1 (LY2624803), serotonin 5-HT2A (ITI-007), melatonin/serotonin5-HT1A (piromelatine) and melatonin (indication expansions of prolonged-release melatonin and tasimelteon for pediatric sleep and circadian rhythm disorders) receptors.<br />Expert Opinion: Low-priced generic environments and high development costs limit the further development of drugs that treat insomnia. However, the bidirectional link between sleep and certain comorbidities may encourage development of specific drugs for comorbid insomnia. New insomnia therapies will most likely move away from GABAAR receptors' modulation to more subtle neurological pathways that regulate the sleep-wake cycle.