Details

Autor(en) / Beteiligte

• ROTH, Thomas
• HULL, Steven G
• LANKFORD, D. Alan
• ROSENBERG, Russell
• SCHARF, Martin B

Titel

Low-Dose Sublingual Zolpidem Tartrate is Associated with Dose-Related Improvement in Sleep Onset and Duration in Insomnia Characterized by Middle-of-the-Night (MOTN) Awakenings

Ist Teil von

• Sleep (New York, N.Y.), 2008-09, Vol.31 (9), p.1277-1284

Ort / Verlag

Rochester, MN: American Academy of Sleep Medicine

Erscheinungsjahr

2008

Quelle

Oxford Journals 2020 Medicine

Beschreibungen/Notizen

• To evaluate the efficacy and safety of low-dose, sublingual zolpidem tartrate when taken during a scheduled middle-of-the-night (MOTN) awakening in subjects with insomnia characterized by difficulty returning to sleep following MOTN awakenings. Randomized, double-blind, placebo-controlled, 3-way crossover study. Each treatment period consisted of 2 consecutive nights of dosing separated by a washout of 5 to 12 days. Subjects were awakened 4 h after lights out, dosed with sublingual zolpidem tartrate (3.5 mg or 1.75 mg) or placebo, kept awake for 30 min, and then returned to bed for an additional 4 h. Sleep parameters were assessed by polysomnography (PSG) and post-sleep questionnaires. Five sleep laboratories. Adults (24 males, 58 females, mean age 45.9 y) with a diagnosis of DSM-IV primary insomnia and a history of prolonged MOTN awakenings. Baseline difficulties with MOTN awakenings were confirmed by a 10-day screening sleep diary and PSG screening. Low-dose sublingual zolpidem tartrate demonstrated significant dose-related decreases in latency to persistent sleep and total sleep time (P < 0.001) compared to placebo after MOTN dosing. All subject reports paralleled PSG observations. Neither dose showed next-morning impairment on the DSST or ratings of sleepiness. The 3.5-mg dose produced improvements in reports of sleep quality (P < 0.001), ability to function, and level of refreshed sleep (P < 0.05 for both dosages) compared to placebo. Sublingual zolpidem tartrate lozenges were generally safe and well tolerated. Low-dose sublingual zolpidem tartrate may be suitable for treatment of patients who have difficulty resuming sleep after MOTN awakenings.