Study: NCT03331042

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SM-1
Description: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SM-1
Description: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SM-1
Description: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: SM-1
Description: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: D+Z
Description: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: D+Z
Description: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: D+Z
Description: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: D+Z
Description: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: D+L
Description: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: D+L
Description: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: D+L
Description: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: D+L
Description: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Placebo
Description: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.