Compositions and methods of treating middle-of-the night insomnia

Abstract

The present invention provides compositions and methods for treating middle-of-the-night insomnia without residual sedative effects upon awakening by administering low doses (about 5 mg or less) of zolpidem or a salt thereof.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Application No. 60 / 684,842, filed May 25, 2005, U.S. Provisional Application No. 60 / 741,673, filed Dec. 1, 2005, U.S. Provisional Application No. 60 / 788,340, filed Mar. 31, 2006, and U.S. Provisional Application No. 60 / 788,249, filed Mar. 31, 2006, the disclosures of which are hereby incorporated by reference in their entirety for all purposes.BACKGROUND OF THE INVENTION [0002] Until recently, medical literature has recognized four types of insomnia, including sleep onset insomnia (e.g., trouble falling asleep at bedtime), sleep maintenance insomnia (e.g., disturbed sleep during the night), early morning awakening, and transient insomnia (e.g., new environment, first night in hotel syndrome). However, according to the National Sleep Foundation's 2005 “Sleep in America” poll, about 20% of total respondents and about 50% of respondents reporting insomnia symptoms complained of waking u...

AI Technical Summary

Benefits of technology

"The present invention provides methods for treating insomnia with zolpidem or a salt thereof. The invention provides solid pharmaceutical compositions and methods for delivering zolpidem across the oral mucosa, which can produce a plasma concentration within 20 minutes of administration and does not produce residual sedative effects when awakened at a time 4 hours after dosing. The invention also provides a method for treating MOTN insomnia in a subject who awakens from sleep and desires to resume sleep for less than 5 hours. The invention provides a solid unit dosage composition for treating insomnia that contains zolpidem or a salt thereof in an amount less than 1.30×10−5 moles and a pharmaceutical composition for delivering zolpidem across the oral mucosa that produces a blood level of zolpidem between about 25 ng / ml and about 50 ng / ml within about 20 minutes of administration."

Problems solved by technology

Unfortunately, currently available hypnotic medications are unsuitable for treating MOTN insomnia because they are slow to induce sleep (e.g., zaleplon) and / or require administration prior to about 7 to 9 hours in bed to avoid residual sleepiness in the morning (e.g., available dosage forms of zolpidem, eszopiclone, and zopiclone).

Also, administration of most presently available hypnotics is prophylactic, resulting in unnecessary medication and overmedication of persons who require treatment for their MOTN insomnia a few nights a week.

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